Status:
COMPLETED
Impact of Gastric Bypass Surgery on Risk of CVD in Type 2 Diabetes Mellitus
Lead Sponsor:
Vanderbilt University
Conditions:
Obese Patients
Type 2 Diabetes Mellitus
Eligibility:
All Genders
18-60 years
Phase:
PHASE3
Brief Summary
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 th...
Detailed Description
Patients with type 2 diabetes mellitus (T2DM) are more likely to die from cardiovascular diseases (CVD) than people without diabetes. Furthermore, patients with diabetes have not benefited from the ad...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2009
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT00444392
Start Date
March 1 2007
End Date
March 1 2009
Last Update
November 21 2016
Active Locations (1)
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1
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232