Impact of GBS on CVD in Type 2 Diabetes Mellitus

Completed · Not applicable

Conditions studied: Obesity, Type 2 Diabetes Mellitus

In brief

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 mechanisms by which surgically induced weight loss reduces over time the risk of CVD in morbidly obsess subjects with T2DM. Study'subjects will be enrolled from obese individuals with type 2 diabetes (T2DM). The study includes two groups, subjects undergoing gastric bypass surgery and a control group not undergoing weight loss surgery. A total of 60 subjects (30 in each group) will be recruited. Basal, 6 and 12 months assessments will include: insulin sensitivity determination, cardiovascular function by echo doppler, and DEXA scan. This study involves risk-level II procedures, however, the risks inherent to the gastric bypass surgery are not considered study-derived because subjects are enrolled from individuals that have already decided to have this surgery. We will determine protein expression profiles of inflammation-related adipokines in the subcutaneous and intra-abdominal adipose tissues of morbidly obese subjects with T2DM before and after surgically induced weight loss.

Key facts

Study ID

NCT00787670

Run by

Duke University

People needed

84

Starts

2008-11-01

Expected to finish

2011-08-01

Last updated by the study team

2013-02-05

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%
• 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.

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

• Duke University Health system — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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