Controlling glycemia, blood pressure, and cholesterol is important for patients with diabetes.
How best to achieve this goal is unknown.
Dr Sayeed Ikramuddin and colleagues compared roux-en-Y gastric bypass with lifestyle and intensive medical management to achieve control of comorbid risk factors.
The research team performed a 12-month, 2-group unblinded randomized trial at 4 teaching hospitals in the United States and Taiwan involving 120 participants who had a hemoglobin A1c (HbA1c) level of 8% or higher, body mass index (BMI) between 30 and 40, C peptide level of more than 1.0 ng/mL, and type 2 diabetes for at least 6 months. The study began in 2008.
The team evaluated lifestyle-intensive medical management intervention and Roux-en-Y gastric bypass surgery.
|Participants in the gastric bypass group lost 26% of their initial body weight |
|Journal of the American Medical Association|
Medications for hyperglycemia, hypertension, and dyslipidemia were prescribed according to protocol and surgical techniques that were standardized.
The team's main outcomes and measures evaluates composite goal of HbA1c less than 7%, low-density lipoprotein cholesterol less than 100 mg/dL, and systolic blood pressure less than 130 mm Hg.
All 120 patients received the intensive lifestyle-medical management protocol, and 60 were randomly assigned to undergo Roux-en-Y gastric bypass.
After 12-months, 28 participants in the gastric bypass group, and 11 in the lifestyle-medical management group achieved the primary end points.
Participants in the gastric bypass group required 3 fewer medications, and lost 26% vs 8% of their initial body weigh compared with the lifestyle-medical management group.
Regression analyses indicated that achieving the composite end point was primarily attributable to weight loss.
There were 22 serious adverse events in the gastric bypass group, including 1 cardiovascular event, and 15 in the lifestyle-medical management group.
The team found 4 perioperative complications, and 6 late postoperative complications.
The gastric bypass group experienced more nutritional deficiency than the lifestyle-medical management group.
Dr Ikramuddin's team commented, "In mild to moderately obese patients with type 2 diabetes, adding gastric bypass surgery to lifestyle and medical management was associated with a greater likelihood of achieving the composite goal."
"Potential benefits of adding gastric bypass surgery to the best lifestyle and medical management strategies of diabetes must be weighed against the risk of serious adverse events."