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Diabetes Affects Breastfeeding; Will Metformin Help?


Yael Waknine

Insulin dysregulation in women during pregnancy and/or just after birth is associated with a low supply of breast milk, data from 2 new studies conducted at Cincinnati Children's Hospital in Ohio suggest.
The first, conducted among 561 women seeking support at the hospital's Breastfeeding Medicine Clinic, found that women experiencing problems with milk supply were 2.5-times more likely to have had gestational diabetes than those who reported "latching-on" problems but had not had issues with milk supply.
The second, much smaller, study found that elevated body mass index (BMI) and glucose and insulin parameters in the prediabetic range were all predictors of insufficient milk supply in women attempting to exclusively breastfeed who had returned to the clinic at 4 weeks' postpartum with concerns.
And in other research, published online May 8 in the journal Public Health Nutrition, researchers in Columbus, Ohio found that women diagnosed with diabetes before or during pregnancy were less likely to initiate and continue breastfeeding their newborns than women without diabetes.
"We need to develop targeted therapies to support lactation success in women with a history of glucose intolerance," said Sarah Riddle, MD, a pediatrician at the Center for Breastfeeding Medicine in Cincinnati and lead author of the larger Cincinnati study, which she presented May 5 at the annual meeting of the Pediatric Academic Societies in Vancouver, British Columbia.
The smaller Cincinnati study was presented April 27 at the Experimental Biology annual meeting in San Diego, California.
First Trial of Metformin to Boost Milk Production Planned
Senior author of both Cincinnati trials, Laurie Nommsen-Rivers, PhD, from the Cincinnati Children's Perinatal Institute, told Medscape Medical News that she and her coworkers now plan to conduct a small randomized controlled study to determine whether the oral hypoglycemic agent metformin boosts milk production in prediabetic mothers.
"Women who present to the clinic with unexplainable difficulty breastfeeding will receive baseline testing, and if they have elevated fasting plasma glucose [FPG] in a range where they might benefit from improving insulin metabolism, they will be enrolled in the Metformin to Augment Low Milk Supply [MALMS] trial," Dr. Nommsen-Rivers said.
"Metformin has never been used in a randomized controlled trial to improve breast-milk supply, but based on the chain of evidence, we feel that it's worth a try," she added, noting the potential impact in a US population where 23% of reproductive-aged women are prediabetic.
Diabetes Linked to Low Milk Supply…
In the first Cincinnati study, researchers reviewed the records of a subset of 175 women who had been diagnosed with low milk supply within 90 days of birth.
"We started with the hypothesis that if metabolic dysregulation is contributing to low milk supply, women presenting with the problem would be more likely to have a history of gestational diabetes," Dr. Nommsen-Rivers explained.
Results confirmed a strong link between diabetes in pregnancy and low milk supply (odds ratio [OR], 2.6; P = .005) that remained unchanged after adjustment for covariates such as maternal and infant age (OR, 2.5; P = .008. Further analysis revealed the effect to also be independent of polycystic ovary syndrome (P = .49), hypothyroidism (P = .62), and infertility (P = .23).
The results support the hypothesis that the same contributors to gestational diabetes (ie, waning pancreatic insulin secretion in the context of insulin resistance) may also contribute to suppressed breast-milk production, Dr Nommsen-Rivers said.
…And to Problems With Breastfeeding
Meanwhile, in the research published by Reena Oza-Frank, PhD, RD, of National Children's Hospital, Columbus, Ohio, and colleagues, women with gestational diabetes were as likely to initiate breastfeeding as women without diabetes, but the gestational-diabetes sufferers were less likely to continue the practice for at least two months.
The data, from the 2009–2011 Pregnancy Risk Assessment Monitoring System (PRAMS), which is administered by the Centers for Disease Control and Prevention, showed that 8.8% of nearly 73,000 women included had gestational diabetes and 1.7% had diabetes prior to pregnancy.
Women with prepregnancy diabetes were less likely to initiate than both other groups of women but continued breastfeeding at about the same rate as women with gestational diabetes.
"We found that women with prepregnancy diabetes had the lowest breastfeeding initiation and continuation rates. However, women with gestational diabetes also had low continuation rates," Dr. Oza-Frank said.
"This study indicates that women with prepregnancy diabetes need additional support both initiating and continuing breastfeeding and that women with gestational diabetes need additional support in continuing breastfeeding."
Obese Moms Can Breastfeed; May Need Extra Support
Finally, in the second much smaller Cincinnati study, the researchers examined the issues from a different angle — by measuring insulin-related factors in 14 obese women concerned about their metabolic health (mean BMI, 32.6). All had given birth in a hospital with strong support for exclusive breastfeeding and expressed a strong intention to do so for at least 1 month.
Results at 1-month follow-up revealed significantly higher fasting plasma glucose levels among the 4 women unable to sustain exclusive breastfeeding, compared with the 10 mothers reporting either abundant or sufficient milk supply (97.2 g/dL vs 86.9 g/dL, P = .02).
"Although all 14 of these moms were overweight, other women with abundant milk supply were also overweight or even obese — yet metabolically healthy," Dr Nommsen-Rivers noted.
"We don't want to give the impression that obese moms can't breastfeed," she emphasized. "We have the convergence of a very strong public-health campaign to promote exclusive breastfeeding at the same time as we have this obesity and diabetes epidemic."
However, it is important to realize that obesity is linked to an increased risk for difficulty lactating, she observed. "Women should plan ahead of time for extra breastfeeding support with a certified lactation consultant or a pediatrician who's knowledgeable about breastfeeding. They should know where to get good follow-up care within a day or 2 of discharge," she added.
"We need to have empathy for our moms who are doing everything they can to exclusively breastfeed, while we are limited by tremendous knowledge gaps in how to help. They deserve better evidence to help support them," she concluded.
Pediatric Academic Societies and Asian Society for Pediatric Research Joint Meeting. May 3-6, 2014.
Public Health Nutr. Published online May 8, 2014. Abstract
FASEB J. 2014;28 (1, supplement 131.1). Abstract








Gastric Band Is First Step Surgery for Morbidly Obese Teens


Lisa Nainggolan

SOFIA, Bulgaria — Among severely obese adolescents, laparoscopic adjustable gastric-band surgery is a reasonable option for weight loss after all other avenues have failed, say experts.
Reporting some of the longest-term results to date, out to 3 years, on a cohort of teenagers who underwent the procedure, pediatrician Myriam Dabbas, MD, of Necker-Enfants Malades Hospital, Paris, France, told the 2014 European Congress on Obesity here that, on the whole, the operation is a success.
"Patients improve their eating behavior rapidly in the first month, and we see the majority of weight loss within the first 2 years," she explained.
Her team also found amelioration of metabolic syndrome among the teenagers who underwent gastric-band surgery and an improvement in cardiovascular-risk profiles. "Losing weight as soon as possible is essential to the future well-being of obese young people," she observed, noting that the teens lost, on average, 40 kg.
However, she stressed that it is very important to have adequate professional support — her team found a correlation between the amount of weight lost and the number of follow-up visits.
Asked to comment, session chair Francois Pattou, MD, a bariatric surgeon from Lille University Hospital, France, said he too performs gastric banding in morbidly obese adolescents and believes it is the best surgical option in this age group due to the low risk associated with it and the reversibility, among other things.
"I think there is a strong, sound clinical rationale [for this procedure] because there is nothing else. These patients are suffering incredibly, and there is no other option," he told Medscape Medical News.
Banding Is a "One-Step-at-a-Time" Approach for Teens
Dr. Dabbas explained that surgery is considered in her center only in patients with a body mass index (BMI) of 40 or greater who are at least 14 years of age and in whom all other approaches have failed, including at least 1 to 2 years of on-site multidisciplinary programs such as group-based and behavioral/lifestyle interventions.
Although some centers perform sleeve gastrectomy and/or gastric bypass on adolescents, and gastric banding is to an extent falling out of favor as an adult bariatric procedure  — because of complications such as band slippage — both Drs. Dabbas and Pattou said they felt banding is the best option in this age group for a number of reasons.
First, weight loss in teenagers needs to be progressive to prevent nutritional deficiencies, and the band allows gradual weight loss, as it can be adjusted, Dr. Dabbas noted.
"It's one step at a time with adolescents," she said, noting that patients can always go on to have further procedures such as sleeve gastrectomy or gastric bypass when they are older.
The reversibility of the band is also a big draw compared with other bariatric procedures, Dr. Pattou added.
"This is important because we are faced with patients who are not deciding [all by] themselves, so in 5 years they might be in terrible dispute with their parents."
And despite sleeve gastrectomy being "a la mode," there are signs that complications are starting to be seen with this procedure too, both doctors told Medscape Medical News.
"Sleeve gastrectomy has advantages: it's quicker, with greater weight loss, but no one knows about the long term," said Dr. Pattou. "In our experience with adults, the 5-year results with the sleeve are not better than with the band. And this is 5 years only, and we are speaking about lifelong maintenance."
Also, it's higher risk, he noted. "The risk of death with sleeve gastrectomy is 0.3%, meaning 3 adolescents will die in 1000. I think this is a toll that is not acceptable" when banding is safe, he observed.
Good Results but Longer-term Follow-up Will Be Key
Dr. Dabbas said her center has been performing gastric banding since 2008, and so far they have operated on 37 teens, of whom 26% were male, with a mean age of 16 (range, 14 to 18 years) who weighed 130 kg, on average, and had a mean BMI of 45. Before surgery, careful psychological evaluation is performed to ensure the patients are suitable candidates, she noted.
Prior to surgery, 60% of the patients had insulin resistance and 75% of them had metabolic syndrome, but no one had developed type 2 diabetes. Almost half of all the females had menstrual disorders.
Three years after surgery, median weight loss was 42 kg, corresponding to 69% excess weight loss.
Most of this was evident the first year after surgery, and weight tended to stabilize after the second year (mean BMI at 2 years was 34 compared with 33.7 at 3 years, a nonsignificant difference), Dr. Dabbas explained. All metabolic parameters were also normal at 3 years, she added, and cardiovascular risk factors, such as dyslipidemia, improved.
She stressed that the extensive follow-up was important in gaining the good results, with the patients having an average of 12 visits in the first year after the operation and 9 in the second year.
Nevertheless, even longer-term follow-up will yield key information, she said, noting that even now, "after 3 years we are beginning to have difficulties, complications, slippage of banding, and patients being lost to follow-up."
And there was a subset of 5 patients in whom the procedure was not particularly successful, who suffered complications such as regurgitation, heartburn, dysphagia, and reflux, she said, noting that her team had been unable to determine why this was — there were no obvious predictors of failure.
Which Surgeons Should Perform the Operation?
Unfortunately, there was also 1 death among the series of 35 patients, the result of an abdominal hemorrhage in a patient who presented to the emergency room some time after surgery.
Dr. Dabbas said all operations were suspended for 6 months following this fatality, but they were unable to determine whether it was related to the surgery.
She explained that the pediatric surgeons in her institution performed the gastric banding, but Dr. Pattou told Medscape Medical News he believes that bariatric surgeons should conduct these operations.
"Very unfortunately, this team had a death, but this is very unexpected and very rare," he noted, acknowledging that it has not been demonstrated that the surgery was a contributory factor in the fatality.
Nevertheless, "this operation should be done with a pediatrician team for follow-up but with a bariatric team for surgery," he stressed. "I think it's a mistake to have a pediatric-surgery team who does only a few of these operations, because these are young anatomical adults."
Dr. Dabbas and Dr. Pattou reported no relevant financial relationships.
2014 European Congress on Obesity. Abstract T5:S1.1, presented May 29, 2014.




Eating Nuts May Help Pause Path to Type 2 Diabetes



Lisa Nainggolan

SOFIA, Bulgaria — Eating nuts could help protect against the development of type 2 diabetes in individuals who are already at high risk for the disease, 2 new studies suggest.
Researchers from Spain and the United States reported on the potential benefits of pistachio nuts and almonds, so-called "tree nuts," here at the 2014 European Congress on Obesity.
Mònica Bulló, MD, of the human nutrition unit at Virgili University, Reus, Spain, and senior author on the pistachio study, told Medscape Medical News: "I would advise people to eat a handful of nuts whenever they can."
Her study, conducted in 49 overweight or obese prediabetic subjects, showed that 57 g of pistachios daily for 4 months significantly reduced fasting glucose, insulin, and insulin resistance. Importantly, there was no change in body weight after eating the nuts.
The other trial, presented in a poster by Sze Yen Tan, PhD, of department of nutrition science, Purdue University, West Lafayette, Indiana, reported on 137 adults at elevated risk for diabetes who were randomized to consume 43 g of almonds per day — either with meals or as a snack — or to no almonds, for 4 weeks.
Those who ate the nuts felt less hungry and fuller than those who didn't, and they had lower postprandial blood glucose levels, without experiencing any weight gain.
Dr. Bulló added that nuts in general have been found to be associated with a reduced risk for coronary heart disease through moderation of LDL cholesterol, triglycerides, and circulating glucose concentrations. And in studies in type 2 diabetes, they have been shown to reduce postmeal glucose and insulin levels, although she admitted findings have been "mixed" in this patient population.
But nuts are, she noted, "a rich, dense food with a healthy lipid profile," and pistachios in particular are rich in antioxidant carotenoids, she added.
However, Dr. Richard Elliott, research communications officer at Diabetes UK, told Medscape Medical News that until full reports of these studies have been published, "We would not be able to make a definitive judgement….We are not aware of any strong evidence that eating nuts reduces the risk of type 2 diabetes."
Potential Protective Role of Pistachios
Despite the prior work on nuts, no previous study has evaluated the effect of nuts in prediabetes, which Dr. Bulló told a press briefing here is "a silent disease," indicating blood glucose levels in the range of 100 to 125 mg/dL, associated comorbidities, and an increased mortality risk.
In the study, reported at the meeting by her colleague Pablo Hernández-Alonso, MD, also of Virgili University, 54 overweight or obese prediabetic people were randomly assigned to a control diet or a pistachios diet (57 g daily, around a "handful" of nuts, said Dr. Bulló) for 4 months. They then had a 2-week washout period before crossing over to the alternative diet for another 4 months, so the individuals effectively acted as their own controls.
The diets were designed to be isocaloric and modified according to each individual's weight: the amount of calories varied from 1900 to 2500 per day, depending on the weight of the person.
Both diets were Mediterranean in nature, and the control diet used olive oil in place of pistachios — the diets did not differ in the amount of saturated fatty acids and cholesterol content. At baseline and then monthly, anthropometric measurements were taken, blood pressure was measured, and physical activity was assessed. Blood samples were also collected at the beginning and end of each intervention period to look at hemostatic, inflammatory, oxidative, and related metabolic risk markers.
There were no statistically significant changes in body mass index (BMI) between intervention periods, but fasting glucose, insulin, and insulin-resistance markers decreased significantly after the pistachio diet compared with the control diet (P < .001).
There were nonsignificant decreases in HbA1c and serum-LDL cholesterol levels; the latter became significant when 5 participants who dropped out for personal reasons were excluded from the analysis.
Other metabolic risk markers such as fibrinogen, glucagonlike peptide-1 (GLP-1), oxidized LDL, and platelet factor-4 all showed a statistically significant decrease after the pistachio diet compared with control diet (P < .05).
"Regular consumption of pistachios could decrease insulin resistance, thus suggesting a potential protective role for pistachio consumption against development of type 2 diabetes," Dr. Bulló concluded.
Almonds Get in on the Action Too, but Are Best as a Snack
Meanwhile, in the almond study, 137 adults at elevated risk of diabetes (BMI 27–35 or normal weight with a family history of diabetes) were randomized to 1 of 3 groups: 43 g per day of almonds (approximately 250 calories) with breakfast or lunch; 43 g of almonds alone as a morning or afternoon snack; or no almonds; for 4 weeks.
Those who ate the almonds felt less hungry and fuller than those who did not consume them; these effects were most noticeable when the almonds were eaten as a snack. Similarly, although almond consumption led to lower blood glucose, this reduction was significant only among those who ate the nuts as a snack.
Adding almonds to the usual diet for 4 weeks did not alter body weight or any other anthropometric measures compared with the control group. The lipid profile of those who consumed the nuts did not improve, however, "possibly because participants were generally healthy and normal-cholesterolemic," said Dr. Tan.
Dr. Tan noted that the US Department of Agriculture recommends the inclusion of about 43 g of nuts per day as part of a healthy diet.
"Overall," he concluded, "inclusion of 43 g of almonds into a daily diet, especially as snacks, may help to moderate glycemia without promoting weight gain."
Dr. Bulló's study was funded by the Western Pistachios Association (United States) and Paramount Farms, but none of the funding sources played a role in the design, collection, analysis, or interpretation of the data, and she said neither she nor her colleagues receive any honoraria from these sources. Dr. Tan's study was funded by the Almond Board of California.
2014 European Congress on Obesity. Abstract T5:OS2.3, presented May 31, 2014.





Diabetes Drug Eyed as Obesity Treatment



Miriam E. Tucker

LAS VEGAS — The glucose-lowering drug liraglutide (Victoza, Novo Nordisk) promotes weight loss in overweight and obese people who don't have diabetes, according to the results of the multinational SCALE — Obesity and Prediabetes trial, presented here at the American Association of Clinical Endocrinologists (AACE) 23rd Annual Scientific and Clinical Congress.
The injectable glucagonlike peptide-1 (GLP-1) agonist performed significantly better than placebo, producing weight loss comparable to that of already-approved weight-loss drugs in other trials, said Xavier Pi-Sunyer, MD, professor of medicine at Columbia University College of Physicians and Surgeons in New York City and codirector of the New York Obesity Nutrition Research Center.
"Patients lost 8% of their body weight from baseline," he told Medscape Medical News. "That's as good as any drug out there. It's better than anything except [phentermine-topiramate], and it's about as good as [phentermine-topiramate]. I think it stacks up pretty well."
On September 11, 2014, a US Food and Drug Administration advisory panel is scheduled to review liraglutide 3.0 mg — a higher dose than the approved 1.8-mg dose used for diabetes — for the new obesity indication.
There was significantly more nausea and vomiting with liraglutide compared with placebo in SCALE, but it resolved with time.
Also, a slightly elevated risk for pancreatitis and gallbladder disorders was seen among patients randomized to liraglutide compared with placebo. "The net effect was under 1% but was slightly more for the drug vs placebo group. It is being investigated and people are being followed," said Dr. Pi-Sunyer.
Low rates of these events preclude any conclusion about causation, Farhad Zangeneh, MD, director of the Endocrine, Diabetes, and Osteoporosis Clinic, Sterling, Virginia, told Medscape Medical News. "Obesity and diabetes [themselves] cause pancreatitis and gallbladder issues. There's a lot of background noise," he said. Dr. Zangeneh was not involved in the study.
Weight Loss
The study enrolled 3731 individuals with a body mass index (BMI) ≥30 kg/m2 or ≥27 kg/m2 with 1 or more comorbidities. Participants were randomized 2:1 to receive once-daily subcutaneous liraglutide 3.0 mg or placebo, along with diet and exercise.
Of the 2590 patients who completed the 56-week study, 78.5% were female with a mean age of 45 years, mean body weight of 106 kg, and mean BMI of 38 kg/m2. Nearly two-thirds had prediabetes. More patients on liraglutide completed the study than those on placebo (72% vs 64%).
At week 56, the liraglutide group had lost 8.0% of their body weight (8.4 kg), compared with 2.6% (2.8 kg) in the placebo group (P < .0001). The proportion of patients who lost 5% or more of their body weight was 64% with liraglutide 3.0 mg vs 27% with placebo (P < .0001); 33% and 10%, respectively, lost more than 10% of their body weight.
Weight loss was independent of prediabetes status or baseline BMI, Dr. Pi-Sunyer reported.
The liraglutide group experienced blood-pressure drops of 2.82 mm Hg (systolic) and 0.89 mm Hg (diastolic). Lipid profiles improved as well, with increases in HDL cholesterol and reductions in LDL and VLDL cholesterol and triglycerides (overall significance P < 0.02).
Gastrointestinal Side Effects
Mild to moderate nausea and vomiting were the most frequently reported side effects. Withdrawal rates due to adverse events — primarily gastrointestinal — were 9.9% for liraglutide vs 3.8% for placebo.
Most of the nausea and vomiting occurred early on, within the first 4 weeks, Dr. Pi-Sunyer told Medscape Medical News. "That's why you do a dose titration, starting with 0.6 mg and work your way up by 0.6-mg increments. Patients get better after 4 to 5 weeks. By 56 weeks, you have very few people who have a problem with [these side effects]."
Rates of gallbladder disorders and pancreatitis were 2.7 and 0.3 events per 100 patient-years for liraglutide, respectively, and 1.1 and 0.1 events per 100 patient-years for placebo, respectively. Both pancreatitis and gallbladder-related problems were reported in 1 patient in the liraglutide group and 1 patient in the placebo group.
The new framework for treating obesity as a chronic disease, previously reported on by Medscape Medical News , requires as much focus on obesity as on diabetes, said Dr. Zangeneh. Lifestyle modifications and medical therapy are needed for both conditions, he said. "Everything in medicine [has a] risk/benefit ratio. To leave people obese is not without risk."
Dr. Pi-Sunyer is on the advisory boards for Novo Nordisk, Vivus, Eisai, Zafgen and Lilly. Dr. Zangeneh is a consultant and/or speaker for Novo Nordisk, AstraZeneca, Eli Lilly, Boehringer Ingelheim, Eisai, Vivus, AbbVie, Janssen, and Bristol-Myers Squibb.
American Association of Clinical Endocrinologists 23rd Annual Scientific and Clinical Congress. Presented May 16, 2014.



Type 2 diabetes: European Commission approves Jardiance® (empagliflozin) tablets for use in adults in Europe



RIDGEFIELD, Conn. and INDIANAPOLIS, May 23, 2014 /PRNewswire/ -- The European Commission granted marketing authorization for Jardiance® (empagliflozin) tablets, a sodium glucose co-transporter 2 (SGLT2) inhibitor, for the treatment of type 2 diabetes mellitus (T2D) to improve glycemic control in adults in Europe, Boehringer Ingelheim Pharmaceuticals, Inc. and Eli Lilly and Company /quotes/zigman/232185/delayed/quotes/nls/lly LLY +0.66% announced.1
The European Commission approved JARDIANCE 10 and 25 mg once daily tablets for use when diet and exercise alone do not provide adequate glycemic control. JARDIANCE may be used alone when metformin is not considered appropriate due to intolerance, or alongside other glucose-lowering medicines including insulin, when glucose control is inadequate.
JARDIANCE is a member of the sodium glucose co-transporter-2 (SGLT2) inhibitor class of compounds. The emerging SGLT2 inhibitor class removes excess glucose through the urine by blocking glucose re-absorption in the kidney.  
"In Europe, the number of people with type 2 diabetes is growing and management of the condition increasingly requires a holistic approach for individuals and their needs," said Professor Klaus Dugi, chief medical officer, Boehringer Ingelheim. "We aim to bring the very latest therapy options to people living with type 2 diabetes and are delighted empagliflozin will become available in Europe."
The marketing authorization is based on results from a clinical program comprised of more than 10 multinational clinical trials and more than 13,000 adults with T2D. Phase III studies showed JARDIANCE 10 and 25 mg significantly reduced hemoglobin A1c (A1c, or average blood glucose) as well as body weight and blood pressure as a stand-alone treatment or in combination with a range of background treatments, including metformin, sulfonylureas, insulin and pioglitazone.1 The most frequently reported adverse reaction was hypoglycemia when used with sulfonylurea or insulin.1 Common side effects experienced with JARDIANCE were genital infection, urinary tract infection, pruritus and increased urination. Genital infection and urinary tract infection were more common in women than men.1 JARDIANCE is not indicated for weight loss or as antihypertensive therapy. Weight loss and  blood pressure change were secondary or exploratory endpoints in clinical trials.
"The approval of empagliflozin marks the third diabetes product from the Boehringer Ingelheim and Lilly Diabetes alliance to be approved in Europe," said Enrique Conterno, president of Lilly Diabetes. "We are proud to continue with our commitment in supporting the varied treatment needs of people living with type 2 diabetes."
About Diabetes Approximately 24.4 million Americans and an estimated 382 million people worldwide have type 1 or type 2 diabetes. T2D is the most common type, accounting for an estimated 85 to 95 percent of all diabetes cases. Diabetes is a chronic condition that occurs when the body either does not properly produce, or use, the hormone insulin. 2
Boehringer Ingelheim and Eli Lilly and Company In January 2011, Boehringer Ingelheim and Eli Lilly and Company announced an alliance in diabetes that centers on compounds representing several of the largest diabetes treatment classes. The alliance leverages the strengths of two of the world's leading pharmaceutical companies. By joining forces, the companies demonstrate commitment in the care of patients with diabetes and stand together to focus on patient needs. Find out more about the alliance at www.boehringer-ingelheim.com or www.lilly.com .
About Boehringer Ingelheim Pharmaceuticals, Inc. Boehringer Ingelheim Pharmaceuticals, Inc., based in Ridgefield, CT, is the largest U.S. subsidiary of Boehringer Ingelheim Corporation (Ridgefield, CT) and a member of the Boehringer Ingelheim group of companies.
The Boehringer Ingelheim group is one of the world's 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 142 affiliates and more than 47,400 employees. Since it was founded in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel medications of high therapeutic value for human and veterinary medicine.
Social responsibility is a central element of Boehringer Ingelheim's culture. Involvement in social projects, caring for employees and their families, and providing equal opportunities for all employees form the foundation of the global operations. Mutual cooperation and respect, as well as environmental protection and sustainability are intrinsic factors in all of Boehringer Ingelheim's endeavors.
In 2013, Boehringer Ingelheim achieved net sales of about $18.7 billion (14.1 billion euro). R&D expenditure in the Prescription Medicines business corresponds to 19.5% of its net sales.
For more information please visit  http://www.us.boehringer-ingelheim.com
About Lilly Diabetes Lilly has been a global leader in diabetes care since 1923, when we introduced the world's first commercial insulin. Today we are building upon this heritage by working to meet the diverse needs of people with diabetes and those who care for them. Through research and collaboration, a broad and growing product portfolio and a continued determination to provide real solutions—from medicines to support programs and more—we strive to make life better for all those affected by diabetes around the world. For more information, visit www.lillydiabetes.com .
This press release contains forward-looking statements about empagliflozin, an investigational compound that is being studied for type 2 diabetes. It reflects Lilly's current beliefs; however, as with any such undertaking, there are substantial risks and uncertainties in the process of drug development and commercialization. There is no guarantee that future study results and patient experience will be consistent with study findings to date or that empagliflozin will receive regulatory approvals or prove to be commercially successful. For further discussion of these and other risks and uncertainties, please see Lilly's latest Forms 10-Q and 10-K filed with the U.S. Securities and Exchange Commission. Lilly undertakes no duty to update forward-looking statements.
References
1 Jardiance® (empagliflozin) tablets. EMA Summary of Product Characteristics. Approval May 2014.
2  International Diabetes Federation. Diabetes Atlas, 6th Edition. 2013. ( http://www.idf.org/diabetesatlas ). Accessed April 23, 2014.
 


Lawyers ask for $60 million for Clark County women who took diabetes drug



By DAVID FERRARA


A pair of Clark County women deserve at least $60 million after developing bladder cancer from taking the diabetes drug Actos, one of their attorneys told a jury Monday.
The lawyers for Delores Cipriano, 81, and Bertha Triana, 80, have said they plan to seek billions of dollars more in punitive damages from the Japan-based drug maker Takeda as the case wraps up this week.
After a three-month trial that started in Las Vegas in February, the jury heard the start of closing arguments Monday in the product liability trial against Asia’s largest drug maker over the cancer risks of the prescription diabetes drug pioglitaone, known as Actos.
Cipriano’s lawyer, Robert Eglet, told jurors that Takeda was “needlessly endangering the public with an unreasonably dangerous drug,” and the company valued profits over patients’ safety.
“Takeda and everyone involved with them doesn’t want to play by the rules,” said Eglet, representing Cipriano, of Henderson, who filed suit against the drug maker last year. “They infected everybody.”
Takeda lawyer Craig Thompson called bladder cancer a “slow-growing disease” and that Actos did not cause the disease in Cipriano or Triana.
“It is critical to respond and set the record straight when necessary,” he said. “It’s critical to respond when incorrect statements are being made. … Our job, our obligation and our goal has been to present our facts and represent our client in a zealous manner.”
Cipriano’s case was consolidated with Triana’s for the trial. Along with thousands across the country, the women said they were not warned about cancer risks.
Eglet asked the jury to award Triana $35 million and Cipriano $25 million in compensatory damages, along with another $3.5 to $5.25 million for Triana’s husband, Hiram for loss of consortium.
“This is a case about corporate greed,” said Eglet, the first lawyer to give a closing argument.
Last month, a federal jury in Louisiana imposed $6 billion in punitive damages against the company.
Before Monday’s arguments started, Clark County District Judge Kerry Earley read a list of 58 jury instructions, including one that stated defense counsel engaged in “pattern of misconduct” throughout the trial, which began with jury instructions Feb. 10.
The instruction was the result of a sanction against the defense attorneys who the judge said repeatedly violated court orders.
Throughout the trial, attorneys for Cipriano and Triana have tried to show that Takeda did not inform patients or doctors about the risk of bladder cancer associated with the use of Actos, first sold in the United States in 1999.
Triana took Actos for two years, between 2005 and 2007, and Cipriano took it for 14 months before the drug maker mentioned the cancer risk in package warnings.
In June 2011, the Food and Drug Administration issued a warning that use of Actos for more than a year may be associated with an increased risk of bladder cancer.
Cipriano and Triana were both diagnosed with bladder cancer in 2012 and have undergone multiple surgeries to remove their tumors.
Takeda destroyed computers and shredded documents that contained information about the risks of the drug, Eglet said.
“They erased everything,” Eglet said. “Is that playing by the rules, or is that playing by Takeda’s rules?”
While Cipriano’s cancer was in remission, Triana discovered last week that her cancer returned, Eglet told the jury as he placed his hand on Triana’s shoulder.
“And you know from the evidence that it’s likelier than 50 percent that the same thing is going to happen to Mrs. Cipriano,” Eglet said, then placing his hand on Cipriano’s shoulder. “Mrs. Cirpiano is not a statistic. She is a living, breathing and feeling human being.”
Eglet asked jurors to “send a message to the community” and quoted Martin Luther King Jr. — “injustice anywhere is a threat to justice everywhere” — in his more than two hour closing argument.
He urged the jury to find that Takeda should pay punitive damages but did not disclose a figure.
“There’s no amount of money that will ever take care of Mrs. Triana and take this away,” Eglet said. “There’s no amount of money that will change what happened to Mrs. Cipriano and take away that fear that this will come back.”
Thompson’s closing argument is slated to continue after the trial resumes at 10:30 a.m. Tuesday.





With diabetes spending over $174 billion annually, including direct water supplies totaling $116 billion for homework and being willing to share your situations and we will share, what's going on?



By COLUMN By DAVID ZINCZENKO | 

If someone you love has ever struggled with the scourge of diabetes, you know what a devastating disease it can be.
Roughly 25.8 million Americans have diabetes, according to the American Diabetes Association, and pre-diabetes -- higher than normal blood glucose levels, but not yet high enough to be diagnosed as diabetes -- affects one in three U.S. adults over the age of 20. Diabetes is a leading cause of heart disease, kidney disease and stroke, and its other complications include blindness, amputation, impotence and nerve damage.
But type 2 diabetes is a relatively preventable disease if you live a healthy lifestyle and learn to Eat It to Beat It. Several studies suggest that belly fat is most strongly correlated with risk factors such as insulin resistance, which sets the stage for the disease, and reducing belly fat through exercise and a healthy diet are the two best ways to prevent and manage the disease.
While you’re at it, consider adopting these healthy dietary habits to help reduce your risk.
Eat red fruits
A recent study suggests that eating a diet rich in anti-inflammatory flavonoids, particularly anthocyanins—compounds that give fruits their red or purple color, could offer protection from type 2 diabetes.
Researchers from the University of East Anglia analyzed questionnaires and blood samples of about 2,000 people and found that those with the highest intakes of flavonoids, particularly from berries and red grapes, had lower insulin resistance and better blood glucose regulation.
Reach for pumpkin seeds
A study at the University of North Carolina at Chapel Hill found that people who consumed the most magnesium in foods and from vitamin supplements (200 milligrams per 1,000 calories) were about half as likely to develop diabetes over the next 20 years as people who took in the least magnesium (100 milligrams per 1,000 calories). Large clinical trials testing the effects of magnesium on diabetes risk are needed to determine whether a causal relationship truly exists.
Researchers also found that as magnesium intake rose, levels of several markers of inflammation decreased, as did resistance to the effects of the key blood sugar-regulating hormone insulin. Higher blood levels of magnesium also were linked to a lower degree of insulin resistance.
Pumpkin seeds and dark chocolate are two of the best food sources. Pair one-quarter cup of pumpkin seeds with just one square of 70 percent chocolate, and your daily need is met!
Eat the whole thing
Simply swap a glass of apple juice for a whole apple and you’ll not only dodge a ton of added sugar and additives, but you may also lower your risk for diabetes, according to a study by the Harvard School of Public Health.
Researchers found that people who ate at least two servings each week of certain whole fruits -- particularly blueberries, grape, and apples -- reduced their risk for type 2 diabetes by as much as 23 percent in comparison to those who ate less than one serving per month. Conversely, those who consumed one or more servings of fruit juice each day increased their risk of developing type 2 diabetes by as much as 21 percent.
Swapping three glasses of juice a week with three servings of whole fruit was associated with a 7 percent risk reduction! The high glycemic index of fruit juice, which passes through the digestive system more rapidly than fiber-rich fruit, may explain the results.
Ditch acid
A study of more than 60,000 women found that an acidic diet that includes more animal products and processed foods than fruit and vegetables was linked to a number of metabolic problems including a reduction in insulin sensitivity. According to the study, women with an “acid load” in the top quartile had a 56 percent increased risk of developing type 2 diabetes compared with the bottom quartile.
Alkaline foods like vegetables, fruits and tea counter acidity.



Effects of Diabetes on Men's Sexual Health


The top cause of sexual health problems for men and women is diabetes. It ranks higher than smoking cigarettes, high cholesterol levels and even hypertension, according to modern research studies. Diabetes impacts nervous system functions, blood flow throughout the body and puts diabetics at risk for problems sexually.
This is understood by experts in the field of diabetic treatment, all over the world. Seeking out the best method of treatment early on, before noticing major health problems can save lives and avoid any undue complications to your sex life. Here are some key facts to understand about diabetes today.
Kenneth Snow, M.D., who studies diabetes for Joslin's Diabetes Center says, "In men, this can commonly manifest as erectile dysfunction. The same problems that lead to decreased blood flow in the arteries in the penis, lead to blockages in the arteries of the heart."
In simplest terms, males with uncontrolled diabetes are at great risk for sexual dysfunctions. Even males with their diabetes under control, maybe prone to sexual health issues more often. Although males who are dealing with their diabetes regularly, will probably have mild manifestations and will respond better to therapeutic treatments.
The primary cause of sexual dysfunctions in male diabetes is damage to the arteries and nerves, both generally and within the genitals. When blood flow to this region is hindered, it can cause erectile dysfunction. Over half of male diabetics show signs of erectile dysfunction, after at least 10 years. As Dr. Snow stated above, research has shown that males with both erectile dysfunction and are diabetic, are at risk for heart disease.
In general, male diabetics can manifest a variety of sexual problems, but the most common is a lower libido. This decrease maybe related to suffering depression or much lower testosterone levels. Also most men experience some premature ejaculation, but many do not realize that it is probably related to their diabetes.  Erectile Dysfunction will appear before any of the other possible disorders, being the same classification of sickness, as coronary artery diseases.
 Approximately 1 third of all people with diabetes don't know it. Also diabetes is the leading cause of blindness in adults, but numbers are equal or equal to the bones, or just give it in, stop crying and ask for your x-box.
Dr. Snow also recently said, "Complications and sexual issues can be avoided by taking proper care of your diabetes. Keep your diabetes, blood pressure, and cholesterol under control."
 Male diabetics need to properly manage their options and treatments, as chosen to combat the harsh consequences of being a full time diabetic. This means being examined and followed up by a clinical professional regularly, possible surgical procedures and the mechanical sex enhancement products for men, such as cock rings, penis pumps and stretching apparatus.
 Sometimes diabetic sufferers will try out new pills for sexual enhancement, such as Cialis and Viagra. Keeping up with your diabetic routine, will make maintaining your sexual health easier. This method is more readily employed by career criminals, but the panic has many people yelling, honking and even listening more intensely.
In Conclusion
Diabetes is a leading cause of sexual health problems, so treat anything that might try to hurt your sexual health or give away their loyalty, all over a brand name in diabetic treatments. Very few have been busy making diabetes more sexy, better understood or tried for personal health reasons. In the last days of women and men, please know that someone is looking for a cure. Diabetes has recently been studied with careful scrutiny.
 Any true complications will automatically save and you profile will be updated immediately. Perhaps a lone female traveler is a good sign tonight. That way every word is heard, yet saying it out-loud is a quick way to happiness, good fortune and a prolific signup page for anonymous individuals in an online community. Streetwise and book learning together, allows African American artists into the backstage of all the big shows.


Untreated Diabetes: What Can Happen and Where You Can Get Help


By Joshua M. Patton, May 21, 2014

Thanks to the miracle that is modern science and medicine, a discovery that you have a certain disease is not necessarily as scary or life-changing as it once was.
People who have diabetes seem to live somewhat normal, healthy lives – with the inconvenience of having to manage their blood sugar levels. One unfortunate side effect of this is that some diabetics, especially younger people who feel the invincibility of youth, may feel that “it’s no big deal” and leave their diabetes untreated.
A 2012 study from the Agency for Healthcare Research and Quality found that 2.4 percent of respondents with diabetes did not use insulin, take oral medication, or follow a healthy diet. Essentially, these people are letting diabetes “take its course.” So what can they expect in the future with untreated diabetes?
What Can Happen
Left untreated, diabetes can affect your long-term health in catastrophic ways. The most serious long-term effects are heart disease and possible kidney-failure. However, there can also be damage to your blood vessels and your eyes. Diabetic ketoacidosis, during which the body breaks down fat stores because it can no longer process sugar, is another serious health complication that can occur. And while mortality is inevitable for all of us, people who do not treat their diabetes will most likely die as a result of one complication or another.
Untreated diabetes can result in both temporary and permanent blindness. There can also be nerve damage in the extremities – typically the hands and feet – which can lead to infection, gangrene and amputation. Along with heart disease and kidney failure, untreated diabetes can also lead to stroke and paralysis.
Where You Can Get Help
Interestingly, the AHRQ study found that very few respondents thought that diabetes was “no big deal,” but instead did not treat diabetes for economic reasons. They either lacked insurance or enough income to adhere to a diabetic diet, opting instead for cheap, sugary processed foods.
If you are not treating diabetes for economic reasons, there are a number of options at your disposal. If your doctor (or any doctor) can’t provide deferred or reduced payments for diabetes treatment, check with local hospitals that might provide “compassionate care.”
There are also free and low-cost health clinics popping up in communities across the country. The National Association of Free and Charitable Clinics is one resource to find them. Your local Department of Welfare office should have that information as well.



Kids and Diabetes: How to recognize and manage low blood sugar


 BY JANET HAAS, RN, CDE 0 COMMENTS

Diabetes occurs when blood sugar levels are too high. So why should you worry about your child getting low blood sugar?
It may seem counterintuitive, but low blood sugar (hypoglycemia) will affect children who have diabetes.
The condition occurs when an individual has excessive insulin, perhaps as a result of taking too much insulin, skipping meals or exercising at a high level. If your child’s blood sugar drops too low, they can become unconscious and/or have a seizure.
Watch for these early warning signs of hypoglycemia:
        Mild reaction – irritability, hunger, weakness, shakiness, headache or stomachache
        Moderate reaction – any of the above, plus drowsiness, paleness, clammy and cold skin, heart pounding, tingling of the lips or tongue, enlarged pupils, behavioral changes, poor concentration, confusion or staggering
        Severe reaction – any of the above plus heavy drowsiness, extreme confusion, unconsciousness or seizures
If your child shows signs of hypoglycemia, respond immediately. The condition can progress from mild discomfort to a severe, life-threatening condition in minutes.
Have your child stop any activity they may be involved in and take the following steps:
Mild/moderate reactions
Follow the Rule of 15 (15 grams of carbohydrate), as follows:
        Dex 4 Glucose® tablets (4 tablets)
        ½ cup (4 oz) orange juice or a 4-oz juice box
Moderate reactions
Give your child the glucose tablets or juice listed above OR one of the following:
        ½ tube of Monojel®
        ½ cup (4 oz) of a soft drink containing sugar – If your child is nauseous, release the carbonation by adding 1 tsp sugar and stirring the drink.
Severe reactions
In cases of unconsciousness or seizures, do not give liquids or food because your child could choke on them. Instead, try squeezing Instant Glucose®, Monojel® or gel-type cake frosting inside their cheek. Use your Glucagon Emergency Kit®.  Always keep an unexpired kit on hand. CALL 911.
Of course prevention is the best way to handle hypoglycemia. Try to avoid the problem by:
        Following your diabetes team’s instructions
        Giving your child their insulin with meals or snacks
        Testing blood sugar levels more often during illness or when your child’s diet or activity level changes



Methi Seeds for Diabetes


  By Sobiya N. Moghul 

Fenugreek or methi seeds are available as fresh leaves, sprouts, dried leaves or dried seeds and can be used whole and in powdered form as a spice.
It is high in soluble fibre, which helps lower blood sugar by slowing down digestion and absorption of carbohydrates. The seeds are a rich source of vitamins, minerals and antioxidants, which help protect the body’s cells from damage caused by free radicals.
 Several clinical studies also point out that fenugreek or methi seeds can treat metabolic symptoms related to type-1 and type-2 diabetes by reducing blood sugar levels and increase blood sugar tolerance levels in the body.
 To decrease the fasting blood sugar levels in the body add 100 gms of methi seed powder to your diet if you are suffering from type-1 diabetes.
 Ways to add fenugreek or methi seeds to your diabetic diet:
•           Add fenugreek leaves to your salads and side dishes.
•           Boil methi seeds in a litre of drinking water and drink this juice regularly.
•           Consume two tbsp of powdered fenugreek seeds with milk everyday.



Whey protein lowers diabetes and cardiovascular disease risk factors in obese adults



Tags: whey protein, obesity, diabetes prevention

(NaturalNews) Whey protein may reduce obese adults' risk of diabetes and cardiovascular disease, according to a study published in the Journal of Proteome Research and funded by the Nordic Centre of Excellence and the Danish Council for Strategic Research.
Whey is a form of protein most commonly found in dairy products such as milk and cheese. It is a popular dietary supplement among muscle builders and recent studies have also suggested that it may have health benefits in people who are obese. Because whey is produced as a byproduct of dairy manufacture, and would have to be disposed of as waste if not purchased, it tends to be low-cost relative to other protein supplements.
Healthier sugar and fat levels
Approximately 35 percent of adults and 17 percent of children in the United States suffer from obesity, placing them at increased risk of developing a variety of health problems, including cardiovascular disease and type 2 diabetes. In this population, high levels of blood sugar and high levels of blood fat after meals are considered major risk signs for diabetes and cardiovascular disease, respectively.
Recent studies have suggested that in obese adults, blood fat levels after meals may be affected, in part, by the type of protein consumed during the meal. Other studies have suggested that whey protein in particular might lower fat levels and also boost production of insulin (thereby lowering blood sugar levels).
In order to examine these issues further, the researchers fed volunteers a meal of soup and bread supplemented with either whey, casein (another milk protein), gluten (a grain protein) or cod protein. They found that the participants who ate the whey protein had lower levels of fatty acids in their blood after meals, as well as higher levels of amino acids that are known to increase insulin levels. This suggests that in obese adults, whey protein could lower the risk of type 2 diabetes and cardiovascular disease.
Many demographics benefit from whey
The study is only the latest to suggest the cardiovascular benefits of whey consumption in some populations. For example, a study conducted by researchers from Washington State University and published in the International Dairy Journal in 2013 found that individuals with high blood pressure taking a daily whey supplement led to a six-point reduction in blood pressure. There was no effect on people who did not have high blood pressure. Prior studies have shown that blood pressure decreases on this scale can reduce the risk of fatal stroke by 35 to 40 percent and also lowers the risk of cardiovascular disease.
"One of the things I like about this is it is low-cost," researcher Susan Fluegel said. "Not only that, whey protein has not been shown to be harmful in any way."
Another study, published in the Journal of the American College of Nutrition in 2013, examined the effect of whey and soy protein supplements on resistance-trained men in their early 20s. Men were randomly assigned to consume 20 grams of whey protein isolate, soy protein isolate or maltodextrin (placebo) every day before engaging in heavy resistance exercise. Participants were not allowed to take any other supplements during the course of the intervention; vegetarians, vegans, and people on high-protein diets were excluded from the study.
The researchers found that after two weeks, resistance athletes who took the whey supplement exhibited a significantly lower stress hormone (cortisol) response following the exercise than patients in the placebo group. In contrast, patients who took soy protein demonstrated decreased blood levels of testosterone.
"Protein supplementation alters the physiological responses to a commonly used exercise modality with some differences due to the type of protein utilized," the researchers wrote.
Sources for this article include:
http://www.acs.org
http://www.diabetes.co.uk
http://www.sciencedaily.com/releases/2013/10/131010091557.htm
http://www.sciencedaily.com/releases/2010/12/101208125624.htm