Bariatric Surgery and Weight Loss on Energy Metabolism and Insulin Sensitivity

Obesity Clinical Trial

— BARIA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00936130
• Other study ID #: PBRC 29004
• Secondary ID: Grant Number 254
• Status: Completed
• Phase: N/A
• First received: July 1, 2009
• Last updated: December 3, 2015
• Start date: September 2010
• Est. completion date: September 2014

Study information

• Verified date: December 2015
• Source: Pennington Biomedical Research Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

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

Intervention

Procedure:
• Laparoscopic Roux-en-Y gastric bypass
Laparoscopic Roux-en-Y gastric bypass surgery
• Laparoscopic gastric banding
Laparoscopic gastric banding surgery
• Laparoscopic sleeve gastrectomy
Laparoscopic sleeve gastrectomy surgery

Behavioral:
• Low Calorie Diet
Low Calorie Diet Program

Locations

Country	Name	City	State
United States	Pennington Biomedial Research Center	Baton Rouge	Louisiana

Sponsors (2)

Lead Sponsor	Collaborator
Pennington Biomedical Research Center	Ethicon Endo-Surgery

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Daily Energy Metabolism and insulin sensitivity	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	No