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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: November 26, 2013
Last verified: November 2013

July 1, 2009
November 26, 2013
September 2010
November 2014   (final data collection date for primary outcome measure)
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.
Measure & 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. [ Time Frame: Enrollment, Baseline, Week 6-8 and Week 48-56 post-surgery / LCD diet ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00936130 on ClinicalTrials.gov Archive Site
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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"

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

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

Probability Sample

Medically qualified for obesity surgery by Drs LeBlanc or Hausmann

  • Obesity
  • Energy Expenditure
  • Body Composition
  • Insulin Sensitivity
  • Response of Gastrointestinal Peptides
  • 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
  • Behavioral: Low Calorie Diet
    Low Calorie Diet Program
    Other Name: LCD
  • Lifestyle counseling
    This group will be comprised of participants on a low calorie diet program.
    Intervention: Behavioral: Low Calorie Diet
  • Weight Loss Surgery
    This group will be comprised of participants having weight loss surgery: Roux-en-Y gastric bypass, gastric banding, or sleeve gastrectomy.
    Interventions:
    • Procedure: Laparoscopic Roux-en-Y gastric bypass
    • Procedure: Laparoscopic gastric banding
    • Procedure: Laparoscopic sleeve gastrectomy
Lam YY, Redman LM, Smith SR, Bray GA, Greenway FL, Johannsen D, Ravussin E. Determinants of sedentary 24-h energy expenditure: equations for energy prescription and adjustment in a respiratory chamber. Am J Clin Nutr. 2014 Apr;99(4):834-42. doi: 10.3945/ajcn.113.079566. Epub 2014 Feb 5.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
48
November 2014
November 2014   (final data collection date for primary outcome measure)

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.
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00936130
PBRC29004, Grant Number 25404
No
Eric Ravussin, Pennington Biomedical Research Center
Pennington Biomedical Research Center
Ethicon Endo-Surgery
Principal Investigator: Eric Ravussin, Ph.D. Pennington Biomedical Research Center
Pennington Biomedical Research Center
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP