Impact of Gastric Bypass Surgery on Risk of CVD in Type 2 Diabetes Mellitus
Completed · Phase 3
Conditions studied: Obese Patients, Type 2 Diabetes Mellitus
In brief
Central hypothesis is: Gastric bypass surgery reduces the risk of CVD in morbidly obese subjects (defined as BMI ≥35 kg/m2) with T2DM. To determine whether surgically induced weight loss decreases the risk of CVD in morbidly obese subjects with T2DM. I hypothesize that patients with T2DM who undergo gastric bypass surgery will significantly reduce mean levels of risk factors for CVD compared with diabetic individuals with the same BMI who maintain their weight.
Key facts
- Study ID
- NCT00444392
- Run by
- Vanderbilt University
- People needed
- 9
- Starts
- 2007-03-01
- Expected to finish
- 2009-03-01
- Last updated by the study team
- 2016-11-21
Who can join
Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Clinical diagnosis of T2DM diabetes mellitus with HbA1c ≤ 10.0%
- Any one of the following will be considered to be sufficient evidence that diabetes is present:
- Current regular use of insulin
- Current regular use of oral hypoglycemic medication.
- Documented diabetes by current ADA criteria (98).
- Body mass index ≥ 35 kg/m2 in accord with the 1991 NIH obesity surgery consensus conference criteria and stable weight for the previous 3 months (99).
- Age between 18-60 years old. Individuals older than 60 years of age are excluded due to their increased risk of mortality and peri-operative morbidity.
- Ability and willingness to provide informed consent.
- No expectation that subject will be moving out of the area of the clinical center during the next 24 months.
You may not qualify if…
- Presence of CVD defined as: CAD, electrocardiographic criteria for past myocardial infarction(s), ischemic stroke, peripheral artery bypass surgery, percutaneous transluminal angioplasty, or amputation because of atherosclerotic disease.
- Significant non-diabetic co-morbidity affecting life expectancy (e.g., malignancy).
- Significant other co-morbidities (e.g. psychiatric disorder) that results in ineligibility for gastric bypass surgery.
- Pregnancy or planning pregnancy.
- Severe dyslipidemia (triglycerides >600 mg/dl or cholesterol >350 mg/dl).
- Uncontrolled hypertension.
- Smoking.
Where it is running
- Vanderbilt University Medical Center — Nashville, Tennessee, United States
Full record on ClinicalTrials.gov
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