5-Year Outcomes: Bariatric Surgery vs Medical Therapy for Diabetes

Good Better Best SignThe final results of the STAMPEDE trial, a study evaluating the use of bariatric surgery and intensive medical therapy in patients with type 2 diabetes and a BMI of 27 to 43, showed that treatment with bariatric surgery was more effective with favorable and durable outcomes.

Bariatric surgery led to more and longer lasting weight loss, greater improvements in health, less pain, and most achieved good to acceptable glycemic control.

About the STAMPEDE Clinical Trial

The study enrolled 150 patients with type 2 diabetes and a body mass index (BMI) between 27 and 43 from the Cleveland Clinic Bariatric and Diabetes Outpatient Clinic from December 2006 to January 2011. The aim of the study was to compare medical therapy with surgical therapy for diabetes control.

Patients were randomly assigned to one of three groups: medical therapy alone or medical therapy combined with bariatric surgery (either laparoscopic Roux-en-Y gastric bypass or laparoscopic sleeve gastrectomy). Patient outcomes were evaluated for a five year period.

Study Results: 5-Year Outcomes

Patients who met primary end-point of a glycated hemoglobin (HbA1c) level of 6% or less:

  • Medical Therapy Group: 2 of 38 patients (5%)
  • Gastric Bypass Group: 14 of 29 patients (29%)
  • Sleeve Gastrectomy Group: 11 of 47 patients (23%)

Reduction in mean HbA1c from baseline:

  • Medical Therapy Group: from 8.8% to 8.5%
  • Gastric Bypass Group: from 9.3% to 7.3%
  • Sleeve Gastrectomy Group: from 9.5% to 7.4%

Observed changes to body weight from baseline:

  • Medical Therapy Group: 5% reduction (mean BMI dropped from 36.4 to 34)
  • Gastric Bypass Group: 23% reduction (mean BMI dropped from 37 to 28.9)
  • Sleeve Gastrectomy Group: 19% reduction (mean BMI dropped from 36 to 29.3)

Changes in triglyceride levels from baseline:

  • Medical Therapy Group: 8% reduction
  • Gastric Bypass Group: 40% reduction
  • Sleeve Gastrectomy Group: 29% reduction

Changes in high-density lipoprotein cholesterol levels from baseline:

  • Medical Therapy Group: 7% reduction
  • Gastric Bypass Group: 32% reduction
  • Sleeve Gastrectomy Group: 30% reduction

Use of insulin from baseline:

  • Medical Therapy Group: 13% reduction (from 53% to 40%)
  • Gastric Bypass Group: 35% reduction (from 47% to 12%)
  • Sleeve Gastrectomy Group: 34% reduction (from 45% to 11%)

Among surgical patients, these benefits were observed:

The drop in HbA1c was similar in patients with a BMI less than 35 compared to those with a BMI equal to or greater than 35. Currently, insurance does not cover bariatric surgery for patients with a BMI less than 35, although this study supports use of bariatric surgery in these patients.

88% of surgical patients achieved good to acceptable glycemic control (defined as a mean HbA1c equal to or less than 7%).

More lasting weight loss and greater improvements in overall health and less pain based on replies to the RAND 36-Item Health Survey, compared to Medical Therapy Group.

Study Information

The final 5-year results of the STAMPEDE trial, “Bariatric Surgery versus Intensive Medical Therapy for Diabetes — 5-Year Outcomes,” were published in the February 15 issue of the New England Journal of Medicine. The ClinicalTrials.gov number is NCT00432809.

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