Key result
Roux-en-Y gastric bypass will be evaluated against standardized medical therapy to determine its efficacy in preventing long-term cardiovascular complications and mortality in 400 non-severely obese patients with insulin-dependent type 2 diabetes.
Why the study?
Does Roux-en-Y gastric bypass reduce a composite of cardiovascular and peripheral vascular events in non-severely obese patients with insulin-dependent type 2 diabetes mellitus?
RCT (n=400)
Open-label
1:1 block randomization
Yes
Does Roux-en-Y gastric bypass reduce a composite of cardiovascular and peripheral vascular events in non-severely obese patients with insulin-dependent type 2 diabetes mellitus?
The DiaSurg 2 trial protocol outlines a randomized study to determine if Roux-en-Y gastric bypass reduces long-term cardiovascular and microvascular morbidity and mortality compared to standard medical therapy in non-severely obese patients with insulin-dependent type 2 diabetes.
Addresses evidence gap for bypass in non-severely obese insulin-dependent diabetes; extends prior CV outcome trials to this population.
BACKGROUND: Type 2 diabetes mellitus (T2DM) is a disease with high prevalence, associated with severe co-morbidities as well as being a huge burden on public health. It is known that glycemic control decreases long-term morbidity and mortality. The current standard therapy for T2DM is medical treatment. Several randomized controlled trials (RCTs) performed in obese patients showed remission of T2DM after bariatric surgery. Recent RCTs have shown bariatric procedures to produce a similar effect in non-morbidly and non-severely obese, insulin-dependent T2DM patients suggesting procedures currently used in bariatric surgery as new therapeutical approach in patients with T2DM. This study aims at investigating whether Roux-en-Y gastric bypass (RYGB) is an efficient treatment for non-severely obese T2DM patients in terms of preventing long-term complications and mortality. METHODS: The DiaSurg 2 trial is a multicenter, open randomized controlled trial comparing RYGB including standardized medical treatment if needed to exclusive standardized medical treatment of T2DM (control group). The primary endpoint is a composite time-to-event endpoint (cardiovascular death, myocardial infarction, coronary bypass, percutaneous coronary intervention, non-fatal stroke, amputation, surgery for peripheral atherosclerotic artery disease), with a follow-up period of 8 years. Insulin-dependent T2DM patients aged between 30 and 65 years will be included and randomly assigned to one of the two groups. The experimental group will receive RYGB and, if needed, standardized medical care, whereas the control group will receive exclusive standardized medical care, both according to the national treatment guidelines for T2DM. Statistical analysis is based on Cox proportional hazards regression for the intention-to-treat population. Assuming a loss to follow-up rate of 20%, 200 patients will be randomly allocated to the comparison groups. A total sample size of n=400 is sufficient to ensure 80% power in a two-tailed significance test at alpha=5%. DISCUSSION: The DiaSurg2 trial will yield long-term data (8 years) on diabetes-associated morbidity and mortality in patients with insulin-dependent T2DM receiving either RYGB or standardized medical care. TRIAL REGISTRATION: The trial protocol has been registered in the German Clinical Trials Register DRKS00004550.
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Kenngott et al. (2013) conducted an RCT in Insulin-dependent type 2 diabetes mellitus (n=400). Roux-en-Y gastric bypass (RYGB) vs. Standardized medical treatment was evaluated on Time to composite of cardiovascular death, non-fatal myocardial infarction, coronary artery bypass grafting, percutaneous coronary intervention, non-fatal stroke, amputation, or surgery for peripheral atherosclerotic artery disease. Roux-en-Y gastric bypass will be evaluated against standardized medical therapy to determine its efficacy in preventing long-term cardiovascular complications and mortality in 400 non-severely obese patients with insulin-dependent type 2 diabetes.
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