2 drugs better than 1 to treat youth with type 2 diabetes

NIH-funded study addresses emerging health problem

2012-04-30

(Press-News.org) A combination of two diabetes drugs, metformin and rosiglitazone, was more effective in treating youth with recent-onset type 2 diabetes than metformin alone, a study funded by the National Institutes of Health (NIH) has found. Adding an intensive lifestyle intervention to metformin provided no more benefit than metformin therapy alone.

The study also found that metformin therapy alone was not an effective treatment for many of these youth. In fact, metformin had a much higher failure rate in study participants than has been reported in studies of adults treated with metformin alone.

The Treatment Options for type 2 Diabetes in Adolescents and Youth (TODAY) study is the first major comparative effectiveness trial for the treatment of type 2 diabetes in young people. TODAY was funded by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), part of NIH. Study results will appear in the New England Journal of Medicine on April 29, 2012.

"The results of this study tell us it might be good to start with a more aggressive drug treatment approach in youth with type 2 diabetes," said Philip Zeitler, M.D., Ph.D., the TODAY study chair and a pediatric endocrinologist at Children's Hospital Colorado, Aurora. "We are learning that type 2 diabetes is a more aggressive disease in youth than in adults and progresses more rapidly, which could be why metformin alone had a higher than expected failure rate."

The TODAY study tested how well and for how long each of three treatment approaches controlled blood glucose levels in youth enrolled from ages 10 to 17 with type 2 diabetes. Participants were randomly assigned to one of three treatment groups: metformin alone, metformin and rosiglitazone together, and metformin plus intensive lifestyle changes aimed at helping participants lose weight and increase physical activity.

The study found that treatment with metformin alone was inadequate for maintaining acceptable, long-term, blood glucose control in 51.7 percent of youth over an average follow-up of 46 months. The failure rate was 38.6 percent in the metformin and rosiglitazone group, a 25.3 percent reduction from metformin alone. In the metformin plus lifestyle group the failure rate was 46.6 percent.

The childhood obesity epidemic has led to the emergence of type 2 diabetes in youth. However, because type 2 diabetes has been primarily an adult illness, information about how to effectively treat youth is limited, and pediatric diabetes experts have had to rely on what is known about adult treatment.

Currently, metformin is the standard treatment for young people with type 2 diabetes and the only oral drug approved for this use by the U.S. Food and Drug Administration.

The longer a person has type 2 diabetes, the greater the likelihood of developing complications including coronary artery disease, stroke, kidney and eye disease, and nerve damage, making it critical for young people with type 2 diabetes to quickly achieve and sustain control of their blood glucose.

"This important study provides much-needed information about how to treat type 2 diabetes in young people. Earlier studies in adults have shown that early, effective treatment can prevent serious and costly diabetes complications later in life," said NIDDK Director Griffin P. Rodgers, M.D. "Longer-term follow up will be important to understand whether more aggressive therapy for youth with type 2 diabetes will yield long-term benefits as they move into adulthood."

In September 2010, the FDA restricted the use of rosiglitazone because of studies linking the medicine to a higher risk of heart attacks and stroke in adults. The TODAY Data Safety and Monitoring Board—an independent group of health and science experts—carefully examined all safety data for TODAY participants and recommended that the study should continue to test rosiglitazone. Rosiglitazone is sold commercially as Avandia.

Studies have shown lifestyle-change programs to be effective in improving blood glucose control for adults with type 2 diabetes. However, the TODAY lifestyle intervention—a family-based weight-management program that included intensive education and activities delivered one-on-one by trained study staff—added no benefit to the metformin therapy. Some youth lost weight during the study, but the majority did not.

"Despite a rigorous lifestyle intervention, we were unable to achieve sustained lifestyle changes in these youth, though similar strategies have proven effective in adults," said Barbara Linder, M.D., Ph.D., NIDDK senior advisor for childhood diabetes research. "TODAY investigators will look more closely at those youth who succeeded in losing weight to better understand how to achieve effective lifestyle change in this population."

The study enrolled 699 youth who had type 2 diabetes for less than two years and a body mass index (BMI) at the 85th percentile or greater. BMI is a measurement of weight in relation to height. Overweight children have a BMI at the 85th to 94th percentile for their age and sex, while obesity is defined as a BMI at the 95th percentile or more. The TODAY participants had an average BMI at the 98th percentile.

###Type 2 diabetes in adults and children is closely linked to being overweight, inactive, and having a family history of diabetes. Type 2 diabetes represents 95 percent of diabetes cases in adults, but is much less common in children than type 1 diabetes. Type 1 diabetes, which usually strikes children and young adults, develops when the body's immune system destroys insulin-producing beta cells in the pancreas.

The TODAY study centers included Children's Hospital Los Angeles Children's Hospital Colorado, Aurora University of Oklahoma Health Sciences Center, Oklahoma City The University of Texas Health Science Center at San Antonio Texas Children's Hospital, Baylor College of Medicine, Houston Washington University School of Medicine, St. Louis Saint Louis University Health Sciences Center, St. Louis Rainbow Babies & Children's Hospital, Cleveland Children's Hospital of Pittsburgh Children's Hospital of Philadelphia Joslin Diabetes Center at SUNY Upstate Medical University, Syracuse, N.Y. Yale University, New Haven, Conn. Massachusetts General Hospital, Boston Joslin Diabetes Center, Boston Berrie Center at Columbia University, New York City Data Coordinating Center at George Washington University, Washington, D.C.

The TODAY study received additional support from BD, Bristol-Myers Squibb, Eli Lilly and Company, GlaxoSmithKline, LifeScan Inc., Pfizer Inc., and Sanofi-aventis.

The NIDDK, part of the NIH, conducts and supports basic and clinical research and research training on some of the most common, severe and disabling conditions affecting Americans. The Institute's research interests include: diabetes and other endocrine and metabolic diseases; digestive diseases, nutrition, and obesity; and kidney, urologic and hematologic diseases. For more information, visit www.niddk.nih.gov.

About the National Institutes of Health (NIH): NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov

NIH…Turning Discovery Into Health

ELSE PRESS RELEASES FROM THIS DATE:

Bioluminescent technology for easy tracking of GMO

2012-04-30

It is important to be able to monitor genetically modified (GM) crops, not only in the field but also during the food processing chain. New research published in BioMed Central's open access journal BMC Biotechnology shows that products from genetically modified crops can be identified at low concentration, using bioluminescent real time reporter (BART) technology and loop mediated isothermal amplification (LAMP). The combination of these techniques was able to recognise 0.1% GM contamination of maize, far below the current EU limit of 0.9%. In agriculture GM crops have ...

Orangutans harbor ancient primate Alu

2012-04-30

Alu elements infiltrated the ancestral primate genome about 65 million years ago. Once gained an Alu element is rarely lost so comparison of Alu between species can be used to map primate evolution and diversity. New research published in BioMed Central's open access journal Mobile DNA has found a single Alu, which appears to be an ancestral great ape Alu, that has uniquely multiplied within the orangutan genome. Analysis of DNA sequences has found over a million Alu elements within each primate genome, many of which are species specific: 5,000 are unique to humans, ...

Breastfeeding is associated with a healthy infant gut

2012-04-30

Early colonization of the gut by microbes in infants is critical for development of their intestinal tract and in immune development. A new study, published in BioMed Central's open access journal Genome Biology, shows that differences in bacterial colonization of formula-fed and breast-fed babies leads to changes in the infant's expression of genes involved in the immune system, and in defense against pathogens. The health of individuals can be influenced by the diversity of microbes colonizing the gut, and microbial colonization can be especially important in regulating ...

A middle-ear microphone

2012-04-30

SALT LAKE CITY, April 30, 2012 – Cochlear implants have restored basic hearing to some 220,000 deaf people, yet a microphone and related electronics must be worn outside the head, raising reliability issues, preventing patients from swimming and creating social stigma. Now, a University of Utah engineer and colleagues in Ohio have developed a tiny prototype microphone that can be implanted in the middle ear to avoid such problems. The proof-of-concept device has been successfully tested in the ear canals of four cadavers, the researchers report in a study just published ...

Yellowstone 'super-eruption' less super, more frequent than thought

2012-04-30

PULLMAN, Wash.— The Yellowstone "super-volcano" is a little less super—but more active—than previously thought. Researchers at Washington State University and the Scottish Universities Environmental Research Centre say the biggest Yellowstone eruption, which created the 2 million year old Huckleberry Ridge deposit, was actually two different eruptions at least 6,000 years apart. Their results paint a new picture of a more active volcano than previously thought and can help recalibrate the likelihood of another big eruption in the future. Before the researchers split ...

Gladstone scientists identify brain circuitry associated with addictive, depressive behaviors

2012-04-30

SAN FRANCISCO, CA—April 29, 2012—Scientists at the Gladstone Institutes have determined how specific circuitry in the brain controls not only body movement but also motivation and learning, providing new insight into neurodegenerative disorders such as Parkinson's disease—and psychiatric disorders such as addiction and depression. Previously, researchers in the laboratory of Gladstone Investigator Anatol Kreitzer, PhD, discovered how an imbalance in the activity of a specific category of brain cells is linked to Parkinson's. Now, in a paper published online today in Nature ...

Tablet-based case conferences improve resident learning

2012-04-30

Tablet based conference mirroring is giving residents an up close and personal look at images and making radiology case conferences a more interactive learning experience, a new study shows. Residents at Northwestern University in Chicago are using tablets and a free screen sharing software during case conferences to see and manipulate the images that are being presented. "The idea stems from the fact that I was used to having presentation slides directly in front of me during medical school lectures. I thought this would benefit radiology residents, especially in ...

MR enterography is as good or better than standard imaging exams for pediatric Crohn's patients

2012-04-30

MR enterography is superior to CT enterography in diagnosing fibrosis in pediatric patients with Crohn disease and equally as good as CT enterography in detecting active inflammation, and a new study shows. The study, conducted at Massachusetts General Hospital in Boston, found that MR enterography was 77.6% accurate in depicting fibrosis compared to 56.9% for CT enterography. MR enterography had an 82.1% accuracy rate versus 77.6% accuracy rate for CT enterography for detecting active inflammation, said Keith Quencer, MD, one of the authors of the study. The study ...

Radiologists rank themselves as less than competent on health policy issues

2012-04-30

Radiologists classify themselves as less competent than other physicians regarding knowledge of patient imaging costs and patient safety, a new study shows. The study conducted at Thomas Jefferson University in Philadelphia and Northwestern University in Chicago compared 711 radiologists to 2,685 non-radiology physicians. "On a scale of one to five, with five being highly competent, understanding of patient safety was rated as 3.1 by radiologists and 3.33 by non-radiologists," said Rajni Natesan, MD, an author of the study from Northwestern University. Patient imaging ...

Study examines benefit of follow-up CT when abdominal ultrasound inconclusive

2012-04-30

About one-third of CT examinations performed following an inconclusive abdominal ultrasound examination have positive findings, according to a study of 449 patients at Massachusetts General Hospital in Boston. Opinions vary as to the need and relevance for further diagnostic imaging workup after an inconclusive abdominal ultrasound examination, said Supriya Gupta, MD, one of the authors of the study. "Our study found that 32.9% of follow-up CT examinations had positive findings, while 42.7% had findings that were not significant and 11.7% were equivocal. The remaining ...

2 drugs better than 1 to treat youth with type 2 diabetes

ELSE PRESS RELEASES FROM THIS DATE:

LAST 30 PRESS RELEASES: