Bariatric Surgery and Weight Loss on Energy Metabolism and Insulin Sensitivity (BARIA)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00936130|
Recruitment Status : Completed
First Posted : July 9, 2009
Last Update Posted : December 4, 2015
|Condition or disease||Intervention/treatment|
|Obesity Protein-energy; Imbalance Insulin Sensitivity Gastrointestinal Complication||Procedure: Laparoscopic Roux-en-Y gastric bypass Procedure: Laparoscopic gastric banding Procedure: Laparoscopic sleeve gastrectomy Behavioral: Low Calorie Diet|
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.
|Study Type :||Observational|
|Actual Enrollment :||48 participants|
|Official Title:||Effect of Bariatric Surgery and Weight Loss on Energy Metabolism and Insulin Sensitivity "BARIA"|
|Study Start Date :||September 2010|
|Actual Primary Completion Date :||September 2014|
|Actual Study Completion Date :||September 2014|
This group will be comprised of participants on a low calorie diet program.
Behavioral: Low Calorie Diet
Low Calorie Diet Program
Other Name: LCD
Weight Loss Surgery
This group will be comprised of participants having weight loss surgery: Roux-en-Y gastric bypass, gastric banding, or sleeve gastrectomy.
Procedure: Laparoscopic Roux-en-Y gastric bypass
Laparoscopic Roux-en-Y gastric bypass surgery
Other Name: RYGB
Procedure: Laparoscopic gastric banding
Laparoscopic gastric banding surgery
Other Name: GBa
Procedure: Laparoscopic sleeve gastrectomy
Laparoscopic sleeve gastrectomy surgery
Other Name: SGx
- Daily Energy Metabolism and insulin sensitivity [ 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.
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00936130
|United States, Louisiana|
|Pennington Biomedial Research Center|
|Baton Rouge, Louisiana, United States, 70808|
|Principal Investigator:||Eric Ravussin, Ph.D.||Pennington Biomedical Research Center|