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Clinical Trial Compares Leading-Edge Treatments for Obesity and Diabetes

Led by Joslin Diabetes Center and Brigham and Women’s Hospital, Boston-area studies will look at weight-loss stomach surgery versus intensive program of lifestyle and medical management

BOSTON, Mass. – February 25, 2010 – Obesity is a major contributing factor to type 2 diabetes, a disease affecting more than 20 million people in the United States. For those who are overweight and have type 2 diabetes, weight loss lowers blood sugar levels and leads to improved health and better quality of life. However, it is difficult to lose weight and keep it off.

Recent studies suggest that bariatric surgery (which promotes weight loss by restricting the body’s ability to take in and process nutrients) may lead to impressive resolutions or even cures for many with type 2 diabetes. During the past decade there also have been many advances with new medications and innovative programs for intensive medical diabetes and weight management programs.

Joslin Diabetes Center and Brigham and Women’s Hospital are joining forces for a clinical trial, now recruiting volunteers in greater Boston, which will compare these two types of treatment.

The project is led by Dr. David Lautz, Director of Bariatric Surgery at Brigham and Women's Hospital and Instructor at Harvard Medical School, and Dr. Allison Goldfine, Head of Clinical Research at Joslin and Associate Professor of Medicine at Harvard Medical School. The two physician researchers have teamed up to compare the effectiveness of two popular types of bariatric surgery to an intensive lifestyle modification and medical management program called Weight Achievement and Intensive Treatment (Why WAIT?) in obese patients with type 2 diabetes.

Known as SLIMM-T2D (Surgery or Lifestyle with Intensive Medical Management in the Treatment of Type 2 Diabetes), the two-year study will examine whether patients test in the non-diabetic range one year after either the surgical or medical and weight management interventions.

Previous observational studies estimate that 60 to 90 percent of bariatric surgery patients who were obese and had type 2 diabetes were later able to maintain normal blood glucose levels without medication.

“Weight loss surgery has become a go-to option for obese patients with type 2 diabetes because of the successes seen,” says Dr. David Lautz. “But we want to compare these two popular procedures with this particular lifestyle modification and medical management program which is also very effective and utilizes significant medical advances, to determine more scientifically what the most effective option is, particularly for the less overweight patient.”

“Unlike common simple diet and exercise plans that are often minimally effective, the  Why WAIT? lifestyle modification program is a proven tool for weight management,” notes Dr. Goldfine. The program was pioneered at the Joslin in 2005 by Dr. Osama Hamdy, Assistant Professor of Medicine at Harvard Medical School, who is collaborating in this research study.

Why WAIT? includes adjustments to diabetes medications to enhance weight reduction, a structured diet with regular food and meal replacements, adherence to Joslin nutrition guidelines, weekly learning sessions with an exercise physiologist and an individualized exercise plan, and weekly group behavioral modification sessions led by a psychologist. After the 12-week program, participants attend monthly support sessions to maintain their weight loss.

The SLIMM-T2D study is the first to examine patients with relatively mild degrees of excess body weight, by including participants with a body mass index (BMI) in the range of 30 to 42. Bariatric surgery is currently approved for patients with a BMI greater than 35 and at least one other medical condition, such as diabetes. However, because the procedure appears to be so effective in treating type 2 diabetes, the researchers are interested in studying whether it might also be effective in treating milder cases of obesity.

Eligible study participants will have type 2 diabetes and a BMI between 30 and 42. To attend an information session or to find out if you qualify for the study, contact Kerri Clancy, R.N., at 617-525-7388 or e-mail BWHSLIMMT2D@partners.org.

The SLIMM-T2D study is supported by a grant from the National Institutes of Health funded through the American Recovery and Reinvestment Act of 2009 (the so-called “stimulus package”) and by Covidien, a provider of healthcare devices.