Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:34 PM
Ignite Modification Date:
2025-12-24 @ 3:34 PM
NCT ID:
NCT00444392
Eligibility Criteria:
Inclusion Criteria:
1. 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).
2. 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).
3. 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.
4. Ability and willingness to provide informed consent.
5. No expectation that subject will be moving out of the area of the clinical center during the next 24 months.
Exclusion Criteria:
1. 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.
2. Significant non-diabetic co-morbidity affecting life expectancy (e.g., malignancy).
3. Significant other co-morbidities (e.g. psychiatric disorder) that results in ineligibility for gastric bypass surgery.
4. Pregnancy or planning pregnancy.
5. Severe dyslipidemia (triglycerides \>600 mg/dl or cholesterol \>350 mg/dl).
6. Uncontrolled hypertension.
7. Smoking.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT00444392
Study Brief:
Protocol Section:
NCT00444392