Bariatric Surgery and Weight Loss on Energy Metabolism and Insulin Sensitivity
NCT ID: NCT00936130
Last Updated: 2015-12-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
48 participants
OBSERVATIONAL
2010-09-30
2014-09-30
Brief Summary
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Detailed Description
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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
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Lifestyle counseling
This group will be comprised of participants on a low calorie diet program.
Low Calorie Diet
Low Calorie Diet Program
Weight Loss Surgery
This group will be comprised of participants having weight loss surgery: Roux-en-Y gastric bypass, gastric banding, or sleeve gastrectomy.
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
Interventions
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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
Low Calorie Diet
Low Calorie Diet Program
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
65 Years
ALL
No
Sponsors
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Ethicon Endo-Surgery
INDUSTRY
Pennington Biomedical Research Center
OTHER
Responsible Party
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Eric Ravussin
p
Principal Investigators
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Eric Ravussin, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Pennington Biomedical Research Center
Locations
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Pennington Biomedial Research Center
Baton Rouge, Louisiana, United States
Countries
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References
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Broskey NT, Obanda DN, Burton JH, Cefalu WT, Ravussin E. Skeletal muscle ceramides and daily fat oxidation in obesity and diabetes. Metabolism. 2018 May;82:118-123. doi: 10.1016/j.metabol.2017.12.012. Epub 2018 Jan 4.
Tam CS, Redman LM, Greenway F, LeBlanc KA, Haussmann MG, Ravussin E. Energy Metabolic Adaptation and Cardiometabolic Improvements One Year After Gastric Bypass, Sleeve Gastrectomy, and Gastric Band. J Clin Endocrinol Metab. 2016 Oct;101(10):3755-3764. doi: 10.1210/jc.2016-1814. Epub 2016 Aug 4.
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.
Other Identifiers
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Grant Number 25404
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
PBRC 29004
Identifier Type: -
Identifier Source: org_study_id