Gastric surgery controlled blood sugar better than intensive medical therapy among obese type 2 diabetics, according to the STAMPEDE trial, the results of which were presented recently at the recent 61st Annual Scientific Sessions of the American College of Cardiology meeting in Chicago, Illinois, US.
Patients who underwent Roux-en-Y gastric bypass surgery or sleeve gastrectomy achieved HbA1c control below 6 percent within a year in 42 percent (P=0.002) and 37 percent of cases (P=0.008), respectively, compared with 12 percent who received intensive medical therapy alone. [N Engl J Med 2012 Mar 26. Epub ahead of print]
“Despite improvements in pharmacotherapy, fewer than 50 percent of patients with moderate-to-severe type 2 diabetes actually achieve and maintain therapeutic thresholds, particularly for glycemic control,” said researchers from the Cleveland Clinic in Ohio, US, Veterans Affairs Boston Healthcare System and Brigham and Women’s Hospital in Boston, Massachusetts, US.
“Observational studies have suggested that bariatric or metabolic surgery can rapidly improve glycemic control...”
The trial randomized 150 obese patients (mean age 49 years, mean body mass index 36 kg/m2, mean HbA1c 9.2 percent) with uncontrolled type 2 diabetes to receive intensive medical therapy alone, medical therapy plus Roux-en-Y gastric bypass surgery or medical therapy plus sleeve gastrectomy.
Intense medical therapy followed the guidelines of the American Diabetes Association and included lifestyle counselling, weight management, and drug therapy.
Patients randomized to surgery experienced significantly more weight loss compared with those receiving medical therapy after 12 months (-29.5 kg gastric bypass, -25.1 kg sleeve gastrectomy, -5.4 kg medical therapy, P<0.001 for both) and lead author Dr. Philip Schauer, of the Cleveland Clinic, said this, more than anything else, was the likely driver for glycemic control.
Mean HbA1c was 6.4 percent in the gastric bypass group (P<0.001), 6.6 percent in the sleeve gastrectomy group (P=0.003) and 7.5 percent among patients receiving medical therapy.
Patients who underwent surgery also significantly reduced or halted use of glucose control and cardiovascular medications.
“Reductions in the use of diabetes medications occurred before achievement of maximal weight loss, which supports the concept that the mechanisms of improvement in diabetes involve physiologic effects in addition to weight loss...” the researchers said.
No deaths or life threatening complications occurred although four patients required a second surgery for complications.
In an accompanying comment, Dr. Paul Zimmet, Baker IDI Heart and Diabetes Institute, Melbourne, VIC, Australia, and Dr. K. George M. M. Alberti, Kings College Hospital, London, England, said surgery would not be the “universal panacea” for obese patients with type 2 diabetes and pointed out that the study duration was only 1 year and that surgery has inherent hazards. [N Engl J Med 2012 Mar 26. Epub ahead of print]
“There is also the problem of ‘remission’ versus ‘cure,’” they said. “Type 2 diabetes is often progressive, and worsening of glycemic control over time is likely in many patients. However, some years of improved glycemia may well result in less microvascular disease.”
Both the researchers and commenters called for further studies on the long-term clinical effects of gastric surgery.
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