STAMPEDE Trial Follow up Substudy

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I had mentioned the results of the STAMPEDE trial (Surgical Therapy and Medications Potentially Eradicate Diabetes Efficiently) in a past Blog post, but there is new information that is worth mentioning.  In the new substudy, the same participants have been reevaluated and the findings are interesting.

To review, the STAMPEDE trial, with its initial results published in 2010, compared the efficacy of intensive medical therapy (IMT) alone, vs. IMT combined with one of two Bariatric procedures, Sleeve Gastrectomy or Gastric Bypass.  The studied participants had Type 2 DM, and a BMI of 27-42.

After 12 months, the main outcome was measured: HbA1C of <6.0%.  They found that among the groups, 12% of the IMT group got to goal, and 42% of the Bypass and 37% of the Sleeve groups got to goal.  It was also concluded that all groups improved in their glycemic control, but the surgical groups did outperform the IMT group, and showed superior weight loss and measured improvement in insulin resistance.

In the follow up substudy, 60 of the original participants were rechecked at 24 months after the study was completed.  They were evaluated for the ongoing effects of the three original treatments in terms of glucose regulation, pancreatic beta-cell function, and body composition.

Glycemic control improved for all three groups at 24 months.  Reduction in body fat was similar for each of the 2 surgical groups, but the Bypass groups showed a greater absolute decrease in truncal fat vs. the Sleeve Gastrectomy group, which did correlate positively with an associated improvement in insulin sensitivity and significantly improved beta-cell function over the Sleeve patients.

The take home point?  Both bariatric surgery groups had a durable and significant improvement in glycemic control, with the addition of improved body composition / decreased body fat.  The favoring of the Bypass results seems to go along with its likely heightened mechanism of metabolic action, as to how and where the weight loss occurs.

Beta-cell failure defines the pathophysiology in DM2, and the exact surgical effects on reversing this cascade to end stage disease is an area of  ongoing study and research.  The exact placement, practically, of metabolic surgery in the aramentarium against Diabetes is the next real question that needs to be answered.  Studies like STAMPEDE, and now its 24 month substudy, will go a long way toward developing these protocols, and best practice scenarios.

And in case you wondered, there are a number of additional studies in the works on similar subjects, as well as another substudy in 24 more months to the same STAMPEDE group.