Diabetes Mellitus Clinical Trial
Official title:
Multicentric Prospective Randomized Controlled Trial on the Effect of Gastric Bypass and Bilopancreatic Diversion on Type 2 Diabetes Mellitus in Patients With BMI Between 30 and 35
200 type 2 diabetic patients -BMI between 30-35- will be submitted to bariatric surgery
(biliopancreatic diversion BPD or gastric bypass GBP ) and 100 will receive standard medical
treatment.
Subjects will be monitored during a 5 year period to assess the effects of the surgical
procedures on diabetes resolution and control at 1, 3 and 5 years.
The study is a multicentric prospective 2-arm randomized controlled trial. Only Centers with
at least 50 bariatric surgeries performed during the time window January 2007 and September
2008 will be allowed to participate in the study.
Each Collaborating Center participating in the study will perform only one type of surgical
procedure (GBP or BPD), depending on which one it is more familiar with.
Patients will be randomly assigned with a 2 to 1 ratio to receive either bariatric surgery
(BS) (either GBP or BPD) or standard antidiabetic care (AC). The randomization will be
centralized in the Coordinating Center. Patients assigned to BS will undergo GBP or BPD,
depending on each Collaborating Center. Recruitment will continue, independently of the
number of recruited patients per center, until the target of 200 GBP+BPD patients, and 100
AC patients will be attained.
After one year since enrollment, patients in AC group will be offered the choice to undergo
one of the two surgical procedures, and then will follow the same protocol study as the
other surgical patients. In addition, each Collaborating Center will be responsible for
selecting one diabetic subject for each operated patient, matched as closely as possible
with the patients assigned to surgical therapy, from the local population in medical
treatment. These patients will serve as controls for long term mortality and morbidity.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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