Compared with intensive medical therapy (IMT) alone, bariatric surgery plus IMT reduced, and in some cases resolved, hyperglycemia in patients with obesity and type 2 diabetes, according to 5-year results of the Surgical Treatment and Medications Potentially Eradicate Diabetes Efficiently (STAMPEDE; ClinicalTrials.gov identifier: NCT00432809) trial.
Researchers of the study, which was published in the New England Journal of Medicine, examined 150 patients with type 2 diabetes and a body mass index ranging from 27 to 43 kg/m2. Patients were randomly assigned to receive IMT alone or IMT plus Roux-en-Y gastric bypass or sleeve gastrectomy.
A glycated hemoglobin level of 6% or less, with or without the use of diabetes medications, served as the primary outcome measure.
Of the surviving patients (1 patient died during follow-up), 90% completed 5-year follow-up. Among these patients, the mean age was 49 ± 8 years, the mean body mass index was 37 ± 3.5 kg/m2, the mean glycated hemoglobin level was 9.2% ± 1.5%, and 66% were women.
At 5 years, the primary end point was achieved in 5% of patients in the IMT group compared with 29% in the gastric bypass group (unadjusted P =.01; adjusted P =.03; intention-to-treat P =.08) and 23% in the sleeve-gastrectomy group (unadjusted P =.03; adjusted P =.07; intention-to-treat P =.17).
Furthermore, compared with IMT patients, those who received surgery experienced a greater mean rate reduction in glycated hemoglobin level (2.1% vs 0.3%; P =.003).
The following outcomes were also significantly improved in the surgery groups at 5 years (P for all <.05):
- Body weight (gastric bypass, −23%; sleeve gastrectomy, −19%; IMT, −5%)
- Triglyceride level (gastric bypass, −40%; sleeve gastrectomy, −29%; IMT, −8%)
- High-density lipoprotein cholesterol level (gastric bypass, 32%; sleeve gastrectomy, 30%; IMT, 7%)
- Use of insulin (gastric bypass, −35%; sleeve gastrectomy, −34%; IMT, −13%)
- Quality-of-life measures, as assessed by general health score increases on the RAND 36-Item Health Survey (gastric bypass, 17; sleeve gastrectomy, 16; IMT, 0.3)
There were no major late surgical complications, aside from 1 reoperation.
“The current 5-year follow-up of patients in our trial showed that the beneficial effects of bariatric surgery on glycemic control were durable, even among patients with mild obesity ([body mass index] of 27 to 34), which led to a sustained reduction in the use of diabetes and cardiovascular medications,” the researchers wrote.
“Changes in body weight, lipid levels, and quality of life after surgery were superior to the changes observed after medical therapy alone. The potential benefits of bariatric surgery on clinical end points, such as myocardial infarction, stroke, renal failure, blindness, and death, as suggested in nonrandomized trials, can be adequately assessed only through larger, multicenter trials.”
The researchers report several financial disclosures with pharmaceutical and device manufacturers, available on the journal’s website.
Schauer PR, Bhatt DL, Kirwan JP, et al. Bariatric surgery versus intensive medical therapy for diabetes — 5-year outcomes. N Engl J Med. 2017;376(7):641-651. doi: 10.1056/nejmoa1600869.