Status:
COMPLETED
Metabolic Parameters 3 Months, 9 Months, and 2 Years After Bariatric Surgery
Lead Sponsor:
The University of Texas Health Science Center, Houston
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Obesity
Diabetes
Eligibility:
All Genders
18-70 years
Brief Summary
An original cohort of 43 patients were recruited for analysis of anthropometrics, metabolic profile, skeletal muscle biopsy, echocardiogram at baseline, 3 months and 9 months post bariatric surgery. W...
Eligibility Criteria
Inclusion
- The subjects in this study will represent both male and female patients with clinically severe obesity (BMI \> 40kg/m2 or 35kg/m2 with significant obesity related co-morbidities), who have chosen to undergo elective bariatric surgery. Patients are screened through the University of Texas Houston Bariatric Surgery Center (UTHBSC) and are evaluated for bariatric surgery, defined in this study as small pouch gastric bypass with Roux-en-Y (SPGB), or laparoscopic adjustable gastric banding (LAGB). Adults (\>18)from diverse ethnic backgrounds, with clinically severe obesity, are eligible to be evaluated for bariatric weight loss surgery in the UTHBSC. Candidates considered for the study are patients who not only fulfill the criteria for weight loss surgery, but also demonstrate a high likelihood of complying with the long-term follow-up that is required for a successful study.
- Patients who have components of the metabolic syndrome (hypertension, diabetes, and dyslipidemia) will be included if these complications do not preclude a safe operation. .
Exclusion
- Exclusion criteria include age over 70 years, current history of smoking, coronary artery disease, congestive heart failure, ischemic cardiomyopathy, known peripheral vascular disease, severe psychiatric disease, any medical problem or physical contraindication for surgery (as determined by the physician) and pregnancy. This study will be limited to adults since the safety of gastric bypass surgery has not been shown to be safe in children in large clinical trials
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Key Trial Info
Start Date :
May 1 2004
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 1 2008
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT00178633
Start Date
May 1 2004
End Date
August 1 2008
Last Update
November 23 2020
Active Locations (1)
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1
University of Texas, Health Sciences Center Houston
Houston, Texas, United States, 77030