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Bariatric Surgery and Weight Loss on Energy Metabolism and Insulin Sensitivity (BARIA)

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Ethicon Endo-Surgery
Information provided by (Responsible Party):
Eric Ravussin, Pennington Biomedical Research Center
ClinicalTrials.gov Identifier:
NCT00936130
First received: July 1, 2009
Last updated: July 26, 2012
Last verified: July 2012
History of Changes
  Purpose

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.


Condition Intervention
Obesity
Energy Expenditure
Body Composition
Insulin Sensitivity
Response of Gastrointestinal Peptides
 Procedure: Laparoscopic Roux-en-Y gastric bypass
Procedure: Laparoscopic gastric banding
Procedure: Laparoscopic sleeve gastrectomy
Behavioral: Low Calorie Diet

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effect of Bariatric Surgery and Weight Loss on Energy Metabolism and Insulin Sensitivity "BARIA"

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Pennington Biomedical Research Center:

Primary Outcome Measures:
  • Daily Energy Metabolism and insulin sensitivity [ Time Frame: Enrollment, Baseline, Week 6-8 and Week 48-56 post-surgery / LCD diet ] [ Designated as safety issue: No ]
    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

Blood draw, urine, stool, fat and muscle biopsies.


Enrollment: 48
Study Start Date: September 2010
Estimated Study Completion Date: November 2012
Estimated Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Lifestyle counseling
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Medically qualified for obesity surgery by Drs LeBlanc or Hausmann

Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00936130

Locations
United States, Louisiana
Pennington Biomedial Research Center
Baton Rouge, Louisiana, United States, 70808
Sponsors and Collaborators
Pennington Biomedical Research Center
Ethicon Endo-Surgery
Investigators
Principal Investigator: Eric Ravussin, Ph.D. Pennington Biomedical Research Center
  More Information

No publications provided

Responsible Party: Eric Ravussin, p, Pennington Biomedical Research Center
ClinicalTrials.gov Identifier: NCT00936130     History of Changes
Other Study ID Numbers: PBRC29004, Grant Number 25404
Study First Received: July 1, 2009
Last Updated: July 26, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Pennington Biomedical Research Center:
Roux-en-Y gastric bypass surgery
Sleeve gastrectomy (SGx) surgery
Gastric banding (GBx) surgery
Low calorie diet program

Additional relevant MeSH terms:
Obesity
Weight Loss
Insulin Resistance
Overnutrition
Nutrition Disorders
Overweight
 Body Weight
Signs and Symptoms
Body Weight Changes
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on June 17, 2013