This trial is active, not recruiting.

Conditions type 2 diabetes, cardiovascular disease
Treatments intensive medical management, rygb & imm
Phase phase 4
Sponsor Covidien
Start date February 2008
End date January 2014
Trial size 120 participants
Trial identifier NCT00641251, AS07008


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
(Active Comparator)
intensive medical management
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.
(Active Comparator)
Roux-en-Y gastric bypass with intensive medical management
rygb & imm
Roux-en-Y gastric bypass Surgery combined with intensive medical management

Primary Outcomes

HbA1c < 7.0%
time frame: 12 Months
Systolic blood pressure < 130 mm Hg
time frame: 12 Months
LDL cholesterol < 100 mg/dl
time frame: 12 Months

Eligibility Criteria

Male or female participants from 30 years up to 67 years old.

Inclusion Criteria: 1. Age 30 to 67 years at eligibility visit. 2. Diagnosed with T2DM at least 6 months prior to enrollment, under the active care of a doctor for at least the six months prior to enrollment, and HbA1c ≥ 8.0 %. 3. Body Mass Index (BMI) ≥ 30.0 kg/m2 and ≤ 39.9 kg/m2 at eligibility visit. 4. Willingness to accept random assignment to either treatment group. 5. Expect to live or work within approximately one hour's traveling time from the study clinic for the duration of the two-year trial. 6. Willingness to comply with the follow-up protocol and successful completion of the run-in (described below). 7. Written informed consent. Exclusion Criteria: 1. Cardiovascular event (myocardial infarction, acute coronary syndrome, coronary artery angioplasty or bypass, stroke) in the past six months. 2. Current evidence of congestive heart failure, angina pectoris, or symptomatic peripheral vascular disease. 3. Cardiac stress test indicating that surgery or IMM would not be safe. 4. Pulmonary embolus or thrombophlebitis in the past six months. 5. Cancer of any kind (except basal cell skin cancer or cancer in situ) unless documented to be disease-free for five years. 6. Significant anemia (hemoglobin 1.0 g or more below normal range) or history of coagulopathy. 7. Serum creatinine ≥ 1.5 mg/dl. 8. HbA1c > 14.0%.

Additional Information

Official title Global Randomized Prospective Study of Intensive Medical Management of Type 2 Diabetes, With and Without Gastric Bypass Surgery
Principal investigator Sayeed Ikramuddin, MD
Trial information was received from ClinicalTrials.gov and was last updated in March 2014.
Information provided to ClinicalTrials.gov by Covidien.