NCT00641251

DSS: Diabetes Surgery Study - Intensive Medical Management of Type 2 Diabetes, With and Without Gastric Bypass Surgery

Global Randomized Prospective Study of Intensive Medical Management of Type 2 Diabetes, With and Without Gastric Bypass Surgery

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Medtronic - MITG · Industry
• Sex: All
• Age: 30 Years – 67 Years
• Healthy volunteers: Not accepted

Summary

The present study is the first stage of a research program whose ultimate goal is to conduct a randomized clinical trial involving type 2 diabetics with BMI from 30.0 to 39.9 kg/m2. This program will determine the relative effectiveness of RYGB combined with intensive medical management (IMM), versus IMM alone, in reducing CVD event rates and mortality in patients with poorly controlled diabetes. IMM will include rigorous lifestyle modification for weight loss and stepped pharmacologic treatment for diabetes and other CVD risk factors. The proposed study is a randomized trial which will provide an assessment of the efficacy of treatment, in reducing CVD risk factors and also assessing the feasibility, cost, and safety of a larger trial.

Conditions

• Type 2 Diabetes
• Cardiovascular Disease

Interventions

Type	Name	Description
OTHER	intensive medical management	IMM will include rigorous lifestyle modification for weight loss and stepped pharmacologic treatment consistent with standard of care for diabetes and other CVD risk factors.
OTHER	RYGB & IMM	Roux-en-Y gastric bypass Surgery combined with intensive medical management

Timeline

• Start date: 2008-02-01
• Primary completion: 2016-12-01
• Completion: 2016-12-01
• First posted: 2008-03-24
• Last updated: 2017-11-29

Locations

5 sites across 2 countries: United States, Taiwan