Bariatric Surgery and Weight Loss on Energy Metabolism and Insulin Sensitivity

Completed

Conditions studied: Obesity, Protein-energy; Imbalance, Insulin Sensitivity, Gastrointestinal Complication

In brief

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.

Key facts

Study ID

NCT00936130

Run by

Pennington Biomedical Research Center

People needed

48

Starts

2010-09-01

Expected to finish

2014-09-01

Last updated by the study team

2015-12-04

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

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

Full record on ClinicalTrials.gov

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