NCT00936130

Bariatric Surgery and Weight Loss on Energy Metabolism and Insulin Sensitivity

Effect of Bariatric Surgery and Weight Loss on Energy Metabolism and Insulin Sensitivity "BARIA"

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 48 (actual)
• Sponsor: Pennington Biomedical Research Center · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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 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.

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 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.

Conditions

• Obesity
• Protein-energy; Imbalance
• Insulin Sensitivity
• Gastrointestinal Complication

Interventions

Type	Name	Description
PROCEDURE	Laparoscopic Roux-en-Y gastric bypass	Laparoscopic Roux-en-Y gastric bypass surgery
PROCEDURE	Laparoscopic gastric banding	Laparoscopic gastric banding surgery
PROCEDURE	Laparoscopic sleeve gastrectomy	Laparoscopic sleeve gastrectomy surgery
BEHAVIORAL	Low Calorie Diet	Low Calorie Diet Program

Timeline

• Start date: 2010-09-01
• Primary completion: 2014-09-01
• Completion: 2014-09-01
• First posted: 2009-07-09
• Last updated: 2015-12-04

Locations

1 site across 1 country: United States