Status:
COMPLETED
Bariatric Surgery and Weight Loss on Energy Metabolism and Insulin Sensitivity
Lead Sponsor:
Pennington Biomedical Research Center
Collaborating Sponsors:
Ethicon Endo-Surgery
Conditions:
Obesity
Protein-energy; Imbalance
Eligibility:
All Genders
18-65 years
Brief Summary
The purpose of the study is to determine the effect of three weight loss surgeries compared to a low calorie diet with regard to energy expenditure, body composition, insulin sensitivity, and the resp...
Detailed Description
The purpose of the study is to determine the effect of three weight loss procedures compared to a low calorie diet. Three different obesity surgery methods; Roux-en-Y gastric bypass (RYGB), gastric ba...
Eligibility Criteria
Inclusion
- Men and women between ages of 18-65 years
- Body mass index \>40 kg/m2 (BMI is calculated from your height and weight)
- BMI \>35 kg/m2 with obesity associated diseases that should improve with weight loss (diabetes, hypertension, and sleep apnea)
- Medically qualified for obesity surgery by Drs LeBlanc or Hausmann
Exclusion
- Women who are pregnant or unwilling to avoid pregnancy for 2 years post-operatively.
- Diabetes diagnosed more than 5 years ago
- Have had diabetes for more than 5 years
- Have had surgery on your stomach or intestinal tract except to remove your appendix or gall bladder.
- Have an active disease in your stomach or intestinal tract including inflammatory bowel disease.
- Have thyroid disease that is not treated
- Have any of the following psychiatric conditions that have not been treated to the point of complete remission: binge eating disorder, bulimia, current physical abuse, current sexual abuse, current substance abuse or dependence, mania or psychosis.
- Have any of the following psychiatric conditions that have not been treated to the point of partial remission prior to your enrollment in this study: anxiety, depression, dysfunctional marriage/family, personality disorder or post-traumatic stress disorder.
- Have a failure of one of your major organ systems. For example, liver failure, kidney failure, severe blood vessel blockage, or are not mentally able to understand the study and give your consent.
- Have a heart pacemaker or defibrillator, or any type of non-removable, metal containing objects in your body, as well as those with tattoos containing metallic dyes.
- Can not drink milk or products containing milk.
- Taking medications that alter your weight or metabolic rate. For example, antipsychotic drugs, beta adrenergic drugs (beta blockers), as well as anorectic drugs.
Key Trial Info
Start Date :
September 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 1 2014
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT00936130
Start Date
September 1 2010
End Date
September 1 2014
Last Update
December 4 2015
Active Locations (1)
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1
Pennington Biomedial Research Center
Baton Rouge, Louisiana, United States, 70808