Metabolic surgery is superior to medical treatment for short-term remission of T2DM and comorbidities .
OBJECTIVE To compare surgical versus medical treatment  of  type 2 diabetes mellitus ( T2DM ) remission and comorbidities in patients with a body mass index ( BMI ) less than 35 kg/m2 .
BACKGROUND Obesity surgery can achieve remission of T2DM and its comorbidities .
Metabolic surgery has been proposed as a treatment option for diabetic patients with BMI less than 35 kg/m2 but the efficacy of metabolic surgery has not been conclusively determined .
DiaSurg 2 trial - surgical vs. medical treatment of insulin-dependent type 2 diabetes mellitus in patients with a body mass index between 26 and 35 kg/m2: study protocol of a randomized controlled multicenter trial - DRKS00004550
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 st and ard therapy for T2DM is medical treatment . Several r and omized 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 r and omized controlled trial comparing RYGB including st and ardized medical treatment if needed to exclusive st and ardized medical treatment of T2DM ( control group ) . The primary endpoint is a composite time-to-event endpoint ( cardiovascular death , myocardial infa rct ion , 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 r and omly assigned to one of the two groups . The experimental group will receive RYGB and , if needed , st and ardized medical care , whereas the control group will receive exclusive st and ardized 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 r and omly 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 st and ardized medical care . Trial registration The trial protocol has been registered in the German Clinical Trials Register DRKS00004550
Metabolic surgery is superior to medical treatment for short-term remission of T2DM and comorbidities .
OBJECTIVE To compare surgical versus medical treatment  of  type 2 diabetes mellitus ( T2DM ) remission and comorbidities in patients with a body mass index ( BMI ) less than 35 kg/m2 .
BACKGROUND Obesity surgery can achieve remission of T2DM and its comorbidities .
Metabolic surgery has been proposed as a treatment option for diabetic patients with BMI less than 35 kg/m2 but the efficacy of metabolic surgery has not been conclusively determined .