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

December 3, 2015 updated by: Eric Ravussin, Pennington Biomedical Research Center

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

48

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70808
        • Pennington Biomedial Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Medically qualified for obesity surgery by Drs LeBlanc or Hausmann

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Lifestyle counseling
This group will be comprised of participants on a low calorie diet program.
Behavioral: Low Calorie Diet
Low Calorie Diet Program
Other Names:
  • 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 Names:
  • RYGB
Procedure: Laparoscopic gastric banding
Laparoscopic gastric banding surgery
Other Names:
  • GBa
Procedure: Laparoscopic sleeve gastrectomy
Laparoscopic sleeve gastrectomy surgery
Other Names:
  • SGx

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Enrollment, Baseline, Week 6-8 and Week 48-56 post-surgery / LCD diet

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pennington Biomedical Research Center

Collaborators

Ethicon Endo-Surgery

Investigators

  • Principal Investigator: Eric Ravussin, Ph.D., Pennington Biomedical Research Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2010

Primary Completion (Actual)

September 1, 2014

Study Completion (Actual)

September 1, 2014

Study Registration Dates

First Submitted

July 1, 2009

First Submitted That Met QC Criteria

July 7, 2009

First Posted (Estimate)

July 9, 2009

Study Record Updates

Last Update Posted (Estimate)

December 4, 2015

Last Update Submitted That Met QC Criteria

December 3, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PBRC 29004
  • Grant Number 25404 (Other Grant/Funding Number: Ethicon)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Obesity

Clinical Trials on Low Calorie Diet

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Saudi Arabia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe