PMID- 23782896
OWN - NLM
STAT- MEDLINE
DCOM- 20150330
LR  - 20211021
IS  - 1745-6215 (Electronic)
IS  - 1745-6215 (Linking)
VI  - 14
DP  - 2013 Jun 20
TI  - 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.
PG  - 183
LID - 10.1186/1745-6215-14-183 [doi]
AB  - 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.
FAU - Kenngott, Hannes G
AU  - Kenngott HG
FAU - Clemens, Gabriella
AU  - Clemens G
FAU - Gondan, Matthias
AU  - Gondan M
FAU - Senft, Jonas
AU  - Senft J
FAU - Diener, Markus K
AU  - Diener MK
FAU - Rudofsky, Gottfried
AU  - Rudofsky G
FAU - Nawroth, Peter P
AU  - Nawroth PP
FAU - Buchler, Markus W
AU  - Buchler MW
FAU - Fischer, Lars
AU  - Fischer L
FAU - Muller-Stich, Beat P
AU  - Muller-Stich BP
LA  - eng
SI  - DRKS/DRKS00004550
PT  - Comparative Study
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20130620
PL  - England
TA  - Trials
JT  - Trials
JID - 101263253
RN  - 0 (Hypoglycemic Agents)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Anastomosis, Roux-en-Y
MH  - *Body Mass Index
MH  - Clinical Protocols
MH  - Diabetes Mellitus, Type 2/blood/diagnosis/mortality/*therapy
MH  - Disease Progression
MH  - Female
MH  - *Gastric Bypass
MH  - Germany
MH  - Humans
MH  - Hypoglycemic Agents/*therapeutic use
MH  - Intention to Treat Analysis
MH  - Male
MH  - Middle Aged
MH  - Obesity/complications/diagnosis/mortality/*surgery
MH  - Proportional Hazards Models
MH  - *Research Design
MH  - Risk Factors
MH  - Sample Size
MH  - Time Factors
MH  - Treatment Outcome
MH  - Weight Loss
PMC - PMC3694456
EDAT- 2013/06/21 06:00
MHDA- 2015/03/31 06:00
PMCR- 2013/06/20
CRDT- 2013/06/21 06:00
PHST- 2012/12/13 00:00 [received]
PHST- 2013/06/04 00:00 [accepted]
PHST- 2013/06/21 06:00 [entrez]
PHST- 2013/06/21 06:00 [pubmed]
PHST- 2015/03/31 06:00 [medline]
PHST- 2013/06/20 00:00 [pmc-release]
AID - 1745-6215-14-183 [pii]
AID - 10.1186/1745-6215-14-183 [doi]
PST - epublish
SO  - Trials. 2013 Jun 20;14:183. doi: 10.1186/1745-6215-14-183.