title: 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.
abstract: 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%.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  The trial protocol has been registered in the German Clinical Trials Register DRKS00004550.
authors.forename: Hannes G
authors.initials: HG
authors.lastname: Kenngott
authors.forename: Gabriella
authors.initials: G
authors.lastname: Clemens
authors.forename: Matthias
authors.initials: M
authors.lastname: Gondan
authors.forename: Jonas
authors.initials: J
authors.lastname: Senft
authors.forename: Markus K
authors.initials: MK
authors.lastname: Diener
authors.forename: Gottfried
authors.initials: G
authors.lastname: Rudofsky
authors.forename: Peter P
authors.initials: PP
authors.lastname: Nawroth
authors.forename: Markus W
authors.initials: MW
authors.lastname: Büchler
authors.forename: Lars
authors.initials: L
authors.lastname: Fischer
authors.forename: Beat P
authors.initials: BP
authors.lastname: Müller-Stich
mesh_terms: D000328:Adult; D000368:Aged; D000713:Anastomosis, Roux-en-Y; D015992:Body Mass Index; D002985:Clinical Protocols; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000175:diagnosis / Q000401:mortality / Q000628:therapy*; D018450:Disease Progression; D005260:Female; D015390:Gastric Bypass; D005858:Germany; D006801:Humans; D007004:Hypoglycemic Agents / Q000627:therapeutic use*; D057194:Intention to Treat Analysis; D008297:Male; D008875:Middle Aged; D009765:Obesity / Q000150:complications / Q000175:diagnosis / Q000401:mortality / Q000601:surgery*; D016016:Proportional Hazards Models; D012107:Research Design; D012307:Risk Factors; D018401:Sample Size; D013997:Time Factors; D016896:Treatment Outcome; D015431:Weight Loss
chemical_list: D007004:Hypoglycemic Agents