Pennington Biomedial Research Center
Baton Rouge, Louisiana, 70808, United States
NCT Number: NCT00936130
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 response of gastrointestinal peptides to a standard meal. Baseline assessments will be conducted in all four groups and changes will be compared six and fifty-two weeks post-operatively.
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Notify Me18 year–65 year
All sexes
Observational
Baton Rouge, Louisiana, 70808, United States
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 banding (GBa), sleeve gastrectomy (SGx), and one low calorie diet program on metabolism, with regard to body fat, physical activity levels, hormone changes after eating a meal, and changes in taste preferences.
Participants having obesity surgery will receive laparoscopic (minimally invasive surgery performed by making several small incisions in the abdomen and inserting a camera called a laparoscope) an adjustable gastric band, a sleeve gastrectomy or roux en Y gastric bypass. In addition to the regular surgical procedures, the surgeons will remove laparoscopically about 10g (1 tablespoon) of fat from within the abdomen. This fat tissue will be processed and stored for future study (at completion of the study) of your metabolism pre-treatment. Participants will complete post-operative follow-up appointments with their surgeon as required.
Participants on the LCD program will experience weight loss by following a low calorie diet program (LCD). For this diet you will select all your own food choices and our dietitians will assist you to reach your daily calorie target. You will be asked to follow this balanced food diet for the remainder of the 12 month study.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Laparoscopic Roux-en-Y gastric bypass surgery
Other names: RYGB
Laparoscopic gastric banding surgery
Other names: GBa
Laparoscopic sleeve gastrectomy surgery
Other names: SGx
Low Calorie Diet Program
Other names: LCD
Time frame: Enrollment, Baseline, Week 6-8 and Week 48-56 post-surgery / LCD diet
Compare daily energy expenditure (accelerometry); body composition (EchoMRI, CT, MRS); insulin sensitivity (2-step hyperinsulinemic euglycemic clamp). Response of insulin, glucose, and gastrointestinal hormones. Changes in the stool microflora.
Pennington Biomedical Research Center
Other
Effect of Bariatric Surgery and Weight Loss on Energy Metabolism and Insulin Sensitivity "BARIA"
Acronym: BARIA
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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