Inhalable insulin for diabetes wins FDA approval

imagesThe Food and Drug Administration on Friday approved a long-delayed inhalable diabetes medication to help patients control their blood sugar levels during meals.

The FDA cleared MannKind Corp.’s drug Afrezza, a fast-acting form of insulin, for adults with the most common form of diabetes that affects more than 25 million Americans. The approval decision comes more than three years after the agency first asked MannKind to run additional clinical studies on the drug.

Diabetes is a chronic condition in which the body either does not make enough insulin to break down the sugar in foods or uses insulin inefficiently. It can lead to blindness, strokes, heart disease or death. In Type 2 diabetes, the most common form of the disease, the body does not use insulin properly. Type 1 diabetes is usually diagnosed in children and young adults. In those cases, the body does not produce insulin.

Afrezza, an insulin powder, comes in a single-use cartridge and is designed to be inhaled at the start of a meal or within 20 minutes of starting. MannKind has said patients using the drug can achieve peak insulin levels within 12 to 15 minutes. That compares to a wait time of an hour and a half or more after patients inject insulin.

The FDA said in its approval announcement that Afrezza is not a substitute for long-acting insulin and is a new option for controlling insulin levels during meals.

The FDA approved the drug with a boxed warning — the strongest type — indicating that the drug should not be used in patients with chronic lung diseases, such as asthma, due to reports of breathing spasms.

Demand for diabetes treatments are surging globally as the prevalence of obesity explodes. Roughly 347 million people worldwide have the disease, according to the World Health Organization.

New effort to fight diabetes in Sonoma County

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Sonoma County medical providers are taking aggressive steps to deal with the high rate of patients with diabetes admitted to local hospitals, a trend that is said to be driving up hospital costs.

In Sonoma County, patients with diabetes account for almost 26 percent of all local hospital admissions, according to a recent UCLA analysis of 2011 hospital patient discharge data. That’s a total of 7,459 hospital admissions.

The added cost of hospital care is estimated at $16.4 million, according to the study, which was conducted by the UCLA Center for Health Policy Research with support from the California Center for Public Health Advocacy.

“We are very concerned about the epidemic of diabetes and the toll that it takes on individuals and the system that cares for them,” said Karen Holbrook, the county’s deputy public health officer.

Holbrook said diabetic patients who are admitted to local hospitals pose more medical complications than those who are not diabetic and often require more tests and treatments. Severe diabetes often results in serious medical conditions such as liver disease and kidney failure, she said.

According to the UCLA study, 31 percent of the state’s hospitalized patients 35 years or older, the age group that accounts for most hospitalizations, had diabetes. The study estimated that the added cost to hospitals in California was $1.6 billion. Hospital stays for diabetic patients in the state cost an average of $2,200 more than for non-diabetic patients, according to the study.

The study’s authors pointed out that 75 percent of this care is covered by Medicare and Medi-Cal, the state’s Medicaid program. Medi-Cal alone pays $254 million in added costs for diabetic patients.

The Tour de Cure event hosted by the American Diabetes Association of Northeast Ohio has already raised $250,000 for diabetes research

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CUYAHOGA FALLS — The Tour de Cure event hosted by the American Diabetes Association of Northeast Ohio has already raised $250,000 for diabetes research in the region, according to Melissa Sutton, the event manager.

The annual event leads riders through a bike route as long as 100 miles. However, riders could also bike shorter distances.

The Saturday ride kicked off at the Cuyahoga Valley Christian Academy on Wyoga Lake Rd. in Cuyahoga Falls.

Participants could also enjoy on-site activities geared towards fun and information about diabetes.

Sutton, who has lived with type one diabetes since she was 9-years-old, says she hopes the ride will combat the stigma the disease faces. “My pancreas stopped working and there’s not a darn thing I can do about it,” Sutton tells Channel 3’s Hilary Golston. “It stops working. So I take it particularly personally when people think it’s a lifestyle disease.”

According to the ADA, 330,000 people have diabetes in Northeast Ohio. “Red riders” or those living with the disease donned red shirts to denote they have diabetes and are participating in the race.

Riders were asked to raise at least $200 to participate, but some raised much more. 11-year-old Gabe Grizwald was able to rake in $2,000. He’s also living with type one diabetes. “I ride for diabetes because it’s just a horrible disease to have and it’s really just changed my life and I think it helps so much when people ride for us and raise money and it really could lead to a cure,” Grizwald tells Golston.

Brian Travalik is Tour de Cure’s red rider ambassador. Decked out in a tutu for flare, he not only lives with diabetes, but represents the so-called “red riders.” Red riders are those who have diabetes and are also participating in Tour de Cure. “It’s a chance to be honored as a hero,” Travalik said. “To see other people with diabetes, it’s a good feeling to be around that comradery of other people that are dealing with that same disease.”

It’s not too late to donate to the cause. You can head over to http://main.diabetes.org/site/TR?fr_id=9375&pg=pfind to give.

 

Human gut cells turned into insulin producers may treat diabetes

Scientists have converted human gut cells into insulin producers by turning off a single gene in an experiment that suggests a novel way forward in treating diabetes.

Using a miniature model of the human intestine, only a few millimeters in size and made from stem cells, the scientists deactivated a gene in the cells tied to metabolic regulation called FOXO1. Once disabled, the cells began producing insulin.

The method, described Monday in the journal Nature Communications, raises the possibility of replacing insulin- making pancreatic beta cells lost in diabetics by using a drug to retrain patients’ existing cells. While progress has been made in generating beta cells from stem cells, the method hasn’t yet produced ones with all the needed functions, said Domenico Accili, the study’s lead author. Plus, such cells would require transplantation.

“We provided a proof of principle that we can do this in human tissues and are also very excited that there is a single identifiable target to trigger this process,” Accili, professor of medicine at Columbia University’s Naomi Berrie Diabetes Research Center in New York, said in an interview. “This is what the pharmaceutical industry is interested in — make a chemical and do what we did in test tubes to administer to persons with diabetes and teach their gut cells to become beta cells.”

The results build on research two years ago by Accili and his team that first tested the approach in mice, successfully converting gut cells into insulin-making cells. In the human cell experiment, the gut cells started releasing insulin after seven days and only in response to insulin.

Now that Accili and his team have shown it works in human cells, their next step is to develop a drug to test in people. Accili said it’s possible that there could be a compound for clinical trials in a year or two.

Diabetes, which results when the body doesn’t use insulin properly or doesn’t make the hormone, is the seventh-leading cause of death in the U.S. Insulin is a hormone secreted by the pancreas that helps the body control blood sugar.

Destruction of insulin-making beta cells in the pancreas is the central feature of Type 1 and Type 2 diabetes. In Type 1 diabetics, the pancreas are destroyed by the immune system and don’t produce insulin. In Type 2, in which the body doesn’t use insulin properly, beta cells become progressively dysfunctional.

One advantage to this experimental approach is that the gastrointestinal tract is partly protected from attack by the immune system, making gut cells less susceptible to destruction, Accili said.

A treatment for diabetes that doesn’t require daily insulin injections would change the treatment landscape for the 29 million diabetics in the U.S. However, it’s likely that any potential drug would first be evaluated for Type 2 diabetes, because of concerns of testing in Type 1 diabetics going without insulin injections, he said.

“The work is a laser-like focus on turning this into a treatment,” Accili said. “We follow 3,000 patients with Type 1 at the Berrie Center alone. That’s our main goal.”

Collaborations with drugmakers are already under way, Accili said, though he declined to name companies.

British drugmaker AstraZeneca Plc helped fund the research, with the National Institutes of Health, the Manpei Suzuki Diabetes Foundation, the Swedish Society for Medical Research, the Japan Society for the Promotion of Science, the JPB Foundation and the Brehm Coalition.

June 30, 2014 ~ Ginger Vieira, Dealing with Diabetes Burnout

photo2Ginger Vieira

Author of Your Diabetes Science Experiment and Emotional Eating with Diabetes, Ginger Vieira has lived with Type 1 diabetes and Celiac disease since 1999, and fibromyalgia since early 2014. Today, she is an avid freelance writer and motivational speaker with a background as a certified cognitive coach, personal trainer, and Ashtanga yoga instructor specializing in coaching people with diabetes. She creates diabetes video blogs at her YouTube Channel and produces regular freelance content for various diabetes websites including DiabetesDaily.com and ASweetLife.org. In 2009 and 2010, Ginger set 15 records in drug-tested powerlifting with her best lifts including a 308 lb deadlift, 190 lb. bench press, and a 265 lb. squat. Today, she lives in Vermont with three dogs and her fella. Living-in-progress.com

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Listen to the latest broadcast of Diabetes Living Today®:  June 3o, 2014 ~ Ginger Vieira on Dealing with Diabetes Burnout.

 

March 31, 2014 ~ Medtronic Insulin Pump Therapy and CGM with Dr. Francine R. Kaufman

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FRANCINE R. KAUFMAN, M.D.

Chief Medical Officer and Vice President, Global Medical,

Clinical & Health Affairs, Medtronic Diabetes

Emeritus Professor of Pediatrics and Communications at USC

The Center for Diabetes, Endocrinology & Metabolism

Francine Ratner Kaufman, M.D. has had a 30 year distinguished careerin diabetes care, research and advocacy.  In 2009, she stepped down as director of the Comprehensive Childhood Diabetes Center, and head of the Center for Endocrinology, Diabetes and Metabolism at Childrens Hospital Los Angeles to become Chief Medical Officer and VP of Global Clinical, Medical and Health affairs at Medtronic Diabetes (Northridge, CA).

 

Dr. Kaufman is also a Distinguished Professor Emerita of Pediatrics and Communications at the Keck School of Medicine and the Annenberg School of Communications of the University of Southern California, and an attending physician at Childrens Hospital Los Angeles.

Dr. Kaufman has published more than 200 peer-reviewed and invited publications. She is the author of more than 30 books or book chapters. In 2008, she edited the 5th edition of the ADA’s the Medical Management of Type 1 Diabetes.  In 2005 her book, Diabesity, was published by Bantam. Diabesity explores the ravages of the obesity and diabetes epidemics as they spread across the globe. Dr. Kaufman was chair of the National Institutes of Health funded Studies to Treat (the TODAY Trial) and Prevent (the HEALTHY Trial) Type 2 Diabetes in Youth (STOPP-T2). She was a principal investigator of TrialNet, a multinational consortium evaluating ways to prevent type 1 diabetes, funded by the National Institutes of Health (NIH).  She has received many awards and honors, including the LA City Council for promoting youth physical fitness (2004), from the State of California for her role in banning sodas from Los Angeles Unified School District (2003), and from the American Diabetes Association (ADA), Juvenile Diabetes Research Foundation (JDRF), European Association for the Study of Diabetes (EASD), Partners in Care, Starbright Foundation, amongst others.

In 2009, Dr. Kaufman was elected to membership in the Advisory Council of the Diabetes Branch of the NIH. In 2007, she filmed a documentary for Discovery Health on the global diabetes epidemic which was aired around the world on World Diabetes Day, November 14, 2007. Also in 2007, Dr. Kaufman was Co-Chair of the Diabetes Work Group for the Department of Health Services of the State of California to recommend diabetes treatment and prevention strategies for the Medicaid population.  In 2005, she was elected Membership in the Institute of Medicine.  Dr. Kaufman was national president of the American Diabetes Association in 2002-03.  She was elected to AOA Medical Honorary Society. She was also president of Shaping America’s Health, chair of the National Diabetes Education Program, and served as chair of the Youth Consultative Section of the International Diabetes Federation.

Listen to the latest broadcast of Diabetes Living Today®:  March 21, 2014 ~ Medtronic Insulin Pump Therapy and CGM with Dr. Francine R. Kaufman

Merck, Bristol Diabetes Drugs Linked to Pancreatitis Risk

Diabetes drugs sold by Merck & Co. (MRK) and Bristol-Myers Squibb Co. (BMY) may double a user’s risk of developing an inflammation of the pancreas linked to cancer and kidney failure, an analysis of insurance records shows.

Patients hospitalized with pancreatitis were twice as likely to be taking Januvia, Merck’s top-selling drug, or using Bristol-Myers’s Byetta, than a control group of diabetics who didn’t have pancreatitis, according to the analysis today in the journal JAMA Internal Medicine. Both drugs increase GLP-1, a hormone that stimulates insulin production from the pancreas.

Doctors have been concerned that this category of diabetes treatments may damage the pancreas since the U.S. Food and Drug Administration said in 2007 it received a high number of reports of pancreatitis in patients taking Byetta. The agency issued a similar alert for Januvia in 2009. The study, which analyzed data from 2005 to 2008, showed a doubling in pancreatitis cases.

“This is the first real study to give an estimate of what the risk is, until now we just had a few case reports,” said Sonal Singh, the study’s author and an assistant professor of medicine at Johns Hopkins University in Baltimore. “These drugs are effective in lower glucose, but we should also consider the risk of pancreatitis and balance the risk versus the benefit.”

Merck, the second-largest U.S. drugmaker, reported $4 billion in sales, or about 9 percent of total revenue, from Januvia last year. The daily pill blocks an enzyme that breaks down GLP-1. Janumet, which combines Januvia with the older diabetes drug metformin, generated $1.7 billion in sales last year for Whitehouse Station, New Jersey-based Merck.

Novo’s Victoza

Bristol-Myers, based in New York, acquired Byetta when it bought Amylin Pharmaceuticals last year for about $5 billion. Byetta, which mimics GLP-1, had sales of $148 million for Bristol-Myers last year, and $159 million for Indianapolis-based Eli Lilly & Co. (LLY), which ended its marketing partnership with Amylin in 2011.

“Bristol-Myers Squibb and AstraZeneca are confident in the positive benefit-risk profile of Byetta and Bydureon as demonstrated by extensive clinical trial data and safety surveillance data,” Ken Dominski, a Bristol-Myers spokesman, said in an e-mail. The companies “will continue to carefully monitor any post-marketing reports of acute pancreatitis.”

AstraZeneca Plc (AZN), based in London, has a partnership with Bristol-Myers on diabetes treatments. Bydureon is a longer acting version of Byetta.

Other drugs that increase the level of GLP-1 in the body include Bristol-Myers’s Onglyza and Novo Nordisk A/S (NOVOB)’s Victoza. The analysis only looked at Januvia and Byetta because the other treatments weren’t on the market during the study period. Januvia was approved in the U.S. in 2006, and Byetta in 2005.

Pancreatic Cancer

Singh said long-term studies should be done to determine if GLP-1 therapies also increase the risk of pancreatic cancer.

“We really need to know more about these drugs as pancreatitis is on the pathway to pancreatic cancer,” he said.

Merck said it has thoroughly reviewed preclinical, clinical and post-marketing safety data and found “no compelling evidence of a causal relationship between” the active ingredient in Januvia and pancreatitis or pancreatic cancer.

“Nothing is more important to Merck than the safety of our medicines and vaccines and the patients who use them,” Pam Eisele, a company spokeswoman, said in a statement.

Diabetes Patients

In diabetics, pancreatitis occurs in about 3 in 1,000 patients. A doubling of that risk, such as that seen in the study, would drive that number to 6 in 1,000 for patients taking Byetta or Januvia, Singh said. About 8.6 percent of Americans, or 25 million people, had diabetes in 2010, according to data compiled by Bloomberg. The number may rise to more than 34 million by 2020.

The study looked at 1,268 diabetics who had been hospitalized with pancreatitis and compared them to the same number of patients who didn’t have the condition. Among those with pancreatitis, 87 had filled a prescription for Byetta or Januvia compared with 58 in the control group. When adjusting for variables that can make a patient more likely to develop pancreatitis, the researchers determined there was a doubling of risk, Singh said.

The study was funded by grants from Johns Hopkins, the National Center for Research Resources, and the National Institutes of Health Roadmap for Medical Research.

To contact the reporter on this story: Shannon Pettypiece in New York at spettypiece@bloomberg.net

To contact the editor responsible for this story: Reg Gale at rgale5@bloomberg.net

“Merry Christmas” There is a Santa Claus and a God!

My Christmas Gift Came, I Am Out Of Rejection!

As many of you may know I have been battling rejection Since June of 2010.  Under going aggressive treatments that has taken a major toll on my body!  The past year and a half has been a real roller coaster ride to say the least.  With many medicine changes, oodles of trips to the lab for blood work, traveling and working with my transplant team, Dr. Nasser I. Youssef, Transplant Surgeon at Our Lady of Lourdes Medical Center (my rock)  and world renowned research scientist from Virgina Eastern Medical School (Dr. Aaron I. Vinik)  to Miami, a big thanks to my family at The Diabetes Research Institute, My friend Gary Kleiman and  Dr. Camillo Ricordi.  Also The University of Maryland Medical Center ~ Transplantation.   The support of my loving family and friends.  I am happy to share with you that this week, I beat my battle with rejection!  I am now out of rejection and my pancreas is working beautiful!  I’ve always said it and will say it again, I was blessed with an awesome donor.  May he enjoy his Christmas in the arms of Jesus and know how much his gift of life has been appreciated!

I will celebrated my Christmas with my close family and friends and start to rebuild my strength.  I thank everyone of you who prayed for me during this time, your spirits will always shine on in my heart!

Our motto at Diabetes Living Today® has always been:  May Kindness Always Be Our Guide! We wish all of you a very Happy Holiday filled with peace and joy!

Caution: New Study Alleging HFCS-Diabetes Link is Flawed and Misleading, Says Corn Refiners Association

WASHINGTON, Nov. 26, 2012 — Authors Target HFCS, while Ignoring it is Nutritionally Equivalent to Sugar

WASHINGTON, Nov. 26, 2012 /PRNewswire-USNewswire/ — A new study, to be released Tuesday, November 27, by researchers from USC and Oxford, uses a severely flawed statistical methodology and ignores well established medical facts to “suggest” a unique link between high fructose corn syrup (HFCS) and Type 2 diabetes. A previous study critical of HFCS from the lead author, Dr. Michael I. Goran, has met with severe criticism for both its study design and conclusions.  Most importantly, Dr. Goran’s newest attack on HFCS fails to account for widespread agreement among scientists and medical doctors that HFCS and sucrose (table sugar) are nutritionally equivalent.

Statement attributed to Audrae Erickson, President, Corn Refiners Association

“This latest article by Dr. Goran is severely flawed, misleading and risks setting off unfounded alarm about a safe and proven food and beverage ingredient.  There is broad scientific consensus that table sugar and high fructose corn syrup are nutritionally and metabolically equivalent.  It is, therefore, highly dubious of Dr. Goran–without any human studies demonstrating a meaningful nutritional difference between high fructose corn syrup and sugar–to point an accusatory finger at one and not the other.  Dr. Goran commits the most fundamental of research errors:  Just because an ingredient is available in a nation’s diet does not mean it is uniquely the cause of a disease.

“If this study shows anything, it is that there is an association between body mass index (BMI) and diabetes prevalence.  Take for example, Japan, where the average BMI is 22.59, and Mexico, where the average BMI is 27.59.  Even though Japan consumes more HFCS every year than Mexico, the prevalence rates of diabetes in Japan are about half of Mexico.  This example alone shows that Dr. Goran’s hypothesis is totally flawed.

“This is not the first time HFCS detractors have tried to use statistical analysis to ‘suggest’ a unique causal link between HFCS and obesity.  The co-authors of the infamous 2004 Bray and Popkin paper, which Dr. Goran relies on, now admit they reached an erroneous hypothesis.  As one author of the 2004 paper confirmed, ‘All sugar you eat is the same, that’s what we know now that we didn’t know in 2004.’

“Rigorous, credible scientific inquiry into the health effects of sweeteners is essential to advancing our understanding of a healthy diet.  But Dr. Goran’s latest quest to condemn high fructose corn syrup crosses the line from science to advocacy.

“The bottom line is this is a poorly conducted analysis, based on a well-known statistical fallacy, by a known detractor of HFCS whose previous attack on the ingredient was deeply flawed and roundly criticized.  The common sense message for consumers to understand is to watch their intake of all extra calories, including all added sugars.”

Statement attributed to James M. Rippe, M.D., Professor, BioMedical Sciences, University of Central Florida (and consultant to CRA)

“Diabetes is a complex disease with many underlying factors.  It is highly unlikely that one component of the diet is uniquely related to diabetes. There are well-established links between obesity and diabetes. That is where we should be focusing our attention rather than vilifying one component of the diet.”

Five Major Reasons the Goran Study is Flawed and Unreliable

1. HFCS and sugar are nutritionally equivalent.  There is broad scientific consensus that HFCS and table sugar are nutritionally and metabolically equivalent, and the American Medical Association has concluded that HFCS is not a unique cause of obesity.  There is absolutely no scientific or medical basis for Dr. Goran to distinguish HFCS from table sugar in terms of human health effects.

2.  Glucose is wrongly compared to fructose.  The studies that are cited by Dr. Goran to justify his belief that fructose is dangerous are largely studies that compare pure fructose to pure glucose, neither of which is consumed in isolation in a normal diet.  HFCS and table sugar contain about equal amounts of glucose and fructose–not fructose or glucose, alone. When the same measurements cited by Dr. Goran are made comparing HFCS to sucrose, all of the differences disappear. Stating that fructose and glucose are treated differently in the liver is misleading and irrelevant. Humans almost always consume these two simple sugars together, not in isolation, and both HFCS and table sugar contain approximately equal amounts of both.

3.  Dr. Goran’s study is based on an “ecological fallacy”.  It associates a characteristic of a large group (diabetes) to a single factor (high fructose corn syrup availability), with no clear evidence of causation.  Comparing levels of HFCS “availability” to a disease with multiple contributing factors (diabetes) is an extremely weak association, particularly given the study’s grandiose claim of a global significance.  In fact, Dr. Goran and his co-authors are forced to admit in their own paper that the arguments they make “could be subject to ecological fallacy” and that the approach they have taken “might introduce errors.”

4.  Goran’s previous HFCS study was shown to be deeply flawed.  For a prior study purporting to find higher than expected fructose in HFCS sweetened drinks, Dr. Goran used the wrong laboratory test methodology.  This flawed approach falsely inflated the levels of fructose and glucose in HFCS and in HFCS-sweetened products.  Dr. Goran later admitted that he and his team “are not disputing the sugar composition of HFCS” and that there were errors caused by the limitations of the method used in the study.  Dr. Goran’s previous study has been roundly criticized.

5.  Isolating one aspect of a national diet and implying that it is a singular cause of diabetes is unwise, unscientific and highly speculative. Diabetes is a complicated condition just like obesity.  The scientific community would not support this kind of approach, linking the availability of one component of the diet to increased risk of diabetes.   For example, drawing from the study’s own data, Japan consumes more high fructose corn syrup every year than does Mexico. Yet the rates of diabetes in Japan are about half of what you see in Mexico.  There are also epidemics of obesity and diabetes in many countries where no high fructose corn syrup is even being used.  Thus, to make a comparison between high and low “availability” of HFCS and diabetes in certain countries is simply misleading.  And Dr. Goran fails to put HFCS and sucrose consumption into proper global perspective: sucrose comprises more than 90% of annual sweetener consumption worldwide.

CONTACT: David Knowles (202) 331-1634

The Corn Refiners Association (CRA) is the national trade association representing the corn refining (wet milling) industry of the United States. CRA and its predecessors have served this important segment of American agribusiness since 1913. Corn refiners manufacture sweeteners, ethanol, starch, bioproducts, corn oil and feed products from corn components such as starch, oil, protein and fiber.

Visit us on the Web at www.Corn.org

SOURCE Corn Refiners Association

Read more here: http://www.sacbee.com/2012/11/26/5010805/caution-new-study-alleging-hfcs.html#storylink=cpy

Study Identifies Possible Protective Blood Factors Against Type 2 Diabetes

BRONX, N.Y., May 3, 2012 /PRNewswire via COMTEX/ — Researchers at Albert Einstein College of Medicine of Yeshiva University in collaboration with Nurses’ Health Study investigators have shown that levels of certain related proteins found in blood are associated with a greatly reduced risk for developing type 2 diabetes up to a decade or more later. The findings, published today in the online edition of Diabetes, could open a new front in the war against diabetes.

These proteins are part of what is called the IGF axis. This axis was named for insulin-like growth factor-1, (IGF-1), so called because it has biological effects similar to those of insulin (the hormone that regulates blood glucose levels) but has a greater effect on cell growth than insulin. The researchers also looked at levels of several proteins known as IGF binding proteins, or IGFBPs, that may have strong effects independent of IGF-1.

Researchers have hypothesized that the IGF axis may influence risk for developing diabetes – an idea supported by laboratory and mouse studies, and a few initial studies in humans. However, the current study is the first large, prospective investigation of several components of the IGF-axis and the risk for developing diabetes, according to co-senior author Howard Strickler, M.D., M.P.H., professor of epidemiology & population health at Einstein.

In the current study, the researchers analyzed levels of IGF-1, IGFBP-1, IGFBP-2, and IGFBP-3 in blood taken from 742 women in the Nurses’ Health Study who years later developed type 2 diabetes as well as a similar number of women in the study who did not develop diabetes. None of the women had any signs or symptoms of the disease at the time their blood samples were taken. The median time between the taking of blood samples and diabetes onset was nine years.

Each component of the IGF axis (IGF-1 and IGFBP-1, -2, and -3) had a significant independent association with diabetes risk – most notably IGFBP-1 and -2. Compared with women in the bottom 20 percent with respect to their levels of IGFBP-1, having high levels of IGFBP-1 (top 20 percent) was associated with a three-fold reduction in risk for diabetes, while high levels of IGFBP-2 were associated with a more than five-fold reduction in diabetes risk.

“Our data provide important new evidence that circulating IGF-axis proteins may have a role in the development of type 2 diabetes,” said Dr. Strickler.

The findings have potential clinical implications. First of all, IGF-axis proteins could help in stratifying people at risk for diabetes. “For example,” said Dr. Strickler, “we know that obesity is a major risk factor for diabetes. But some overweight individuals don’t develop diabetes, while some thin people do. If our findings are confirmed, they could help doctors more precisely determine who is actually at risk for the disease.”

The proteins may also prove useful as targets for novel therapies to prevent or treat diabetes. But Dr. Strickler cautions that it’s too early to apply these findings to clinical practice. “IGF-axis proteins have other effects, some beneficial and some not,” he notes. “We need to learn more about the connection between the IGF-axis and diabetes before we recommend that people get tested for these substances, and before deciding how we can exploit the IGF-1 axis to help address diabetes.”

The Diabetes paper is titled, “The Insulin-Like Growth Factor Axis and Risk of Type 2 Diabetes in Women.” The first author was Swapnil Rajpathak (who was at Einstein at the time this work was conducted). The other senior author is Frank B. Hu, M.D., Ph.D, of Harvard School of Public Health, Boston, MA. Additional contributors include Meian He, M.D., Ph.D., (Harvard and Huazhong University of Science and Technology, Wuhan, Hubei, China); Qi Sun M.D., Sc.D., (Harvard); Jeannette Beasley, Ph.D., R.D., M.P.H., (Fred Hutchinson Cancer Research Center, Seattle, WA); Michael Pollak, M.D., (McGill University, Montreal, Quebec, Canada); and Robert Kaplan, Ph.D., Radhika Muzumdar M.D., M.B.B.S., Thomas Rohan, M.D., Ph.D., Mimi Kim, Sci.D., Jeffrey Pessin, Ph.D., and Judith Wylie-Rosett, Ed.D., all of Einstein. Co-author Marc Gunter, Ph.D., contributed to the paper while at Einstein.

The study was supported by grants from the National Institutes of Health. Laboratory testing and data analysis were supported in part by NIDDK 5-R01-DK-080792. The NHS is supported by grants CA-87969, DK-58845, and DK-58785 from the National Institute of Diabetes and Digestive and Kidney Diseases and the National Institute of Child Health and Human Development. Q.S. was supported by a career development award (K99HL098459) from the National Heart, Lung, and Blood Institute. The authors report no conflicts of interest.

About Albert Einstein College of Medicine of Yeshiva University

Albert Einstein College of Medicine of Yeshiva University is one of the nation’s premier centers for research, medical education and clinical investigation. During the 2011-2012 academic year, Einstein is home to 724 M.D. students, 248 Ph.D. students, 117 students in the combined M.D./Ph.D. program, and 368 postdoctoral research fellows. The College of Medicine has 2,522 full time faculty members located on the main campus and at its clinical affiliates. In 2011, Einstein received nearly $170 million in awards from the NIH. This includes the funding of major research centers at Einstein in diabetes, cancer, liver disease, and AIDS. Other areas where the College of Medicine is concentrating its efforts include developmental brain research, neuroscience, cardiac disease, and initiatives to reduce and eliminate ethnic and racial health disparities. Its partnership with Montefiore Medical Center, the University Hospital and academic medical center for Einstein, advances clinical and translational research to accelerate the pace at which new discoveries become the treatments and therapies that benefit patients. Through its extensive affiliation network involving Montefiore, Jacobi Medical Center – Einstein’s founding hospital, and five other hospital systems in the Bronx, Manhattan, Long Island and Brooklyn, Einstein runs one of the largest post-graduate medical training programs in the United States, offering approximately 155 residency programs to more than 2,200 physicians in training. For more information, please visit www.einstein.yu.edu and follow us on Twitter @EinsteinMed.

SOURCE Albert Einstein College of Medicine

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