Status:
COMPLETED
Impact of GBS on CVD in Type 2 Diabetes Mellitus
Lead Sponsor:
Duke University
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Obesity
Type 2 Diabetes Mellitus
Eligibility:
All Genders
18-60 years
Phase:
NA
Brief Summary
This research is a NIH single site study with the aims to (1) determine whether surgically induced weight loss decreases the risk of CVD in morbidly obese subjects with T2DM. (2) elucidate the mechani...
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
- Inclusion criteria:
- Clinical diagnosis of T2DM diabetes mellitus with HbA1c ≤ 10.0%
- 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
- Age between 18-60 years old.
- 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 12 months.
- Exclusion criteria:
- 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
Exclusion
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2011
Estimated Enrollment :
84 Patients enrolled
Trial Details
Trial ID
NCT00787670
Start Date
November 1 2008
End Date
August 1 2011
Last Update
February 5 2013
Active Locations (1)
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1
Duke University Health system
Durham, North Carolina, United States, 27704