Short-term Investigation of Resveratrol on Fat Metabolism in Morbidly Obese Women Undergoing Gastric Bypass Surgery

Study Overview
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Brief Summary
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The purpose of this study is to investigate potential metabolic effects of resveratrol in morbidly obese women undergoing gastric bypass surgery. The investigators hypothesize that resveratrol will: Decrease hepatic very-low-density-lipoprotein-triglyceride (VLDL-TG) secretion Decrease hepatic and adipose tissue VLDL-TG uptake Increase insulin sensitivity The investigators will look at changes in: Lipid turnover (VLDL-TG kinetics, palmitate kinetics,calorimetry) VLDL-TG uptake in different tissues (subcutaneous femoral adipose tissue, subcutaneous abdominal adipose tissue, visceral adipose tissue and liver tissue) Insulin sensitivity (glucose kinetics during hyperinsulinaemic euglycaemic clamp) Regulation of liver fat handling Lipoprotein lipase activity and fat cell size (abdominal and femoral adipose tissue)

Official Title
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Short-term Investigation of Resveratrol on Lipid Turnover in Morbidly Obese Women Undergoing Gastric Bypass Surgery. Effects on Basal and Insulin Stimulated FFA and VLDL-triglyceride Metabolism and Liver VLDL-triglyceride Uptake.

Conditions
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Obesity

Intervention / Treatment
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* Dietary Supplement: Resveratrol
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female 25-60 years Obesity (BMI > 35 kg/m2) Have at least one element of the metabolic syndrome either hypertension and/or hypercholesterolemia (high triglyceride, low HDL-cholesterol) Undergoing gastric bypass surgery Written informed consent Exclusion Criteria: Any other relevant disease (e.g. diabetes, thyroid or parathyroid disease, heart, kidney or liver disease) May have arthrosis or depression Any present or previous malignancy History of smoking Alcohol dependency (more than 14 units of alcohol per week) Participation in studies with radioactive isotope within the last six months Hemoglobin under the normal range regarding to sex (under 7.3 mmol/l for women)

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Resveratrol<br>Resveratrol 500mg 3 times daily for 1 month | Dietary Supplement: Resveratrol<br>* 500mg 3 times daily for 1 month<br>|
| Placebo Comparator: Placebo<br>Placebo 1 tablet 3 times daily for 1 month | Other: Placebo<br>* 1 placebo tablet 3 times daily for 1 month<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hepatic VLDL-TG secretion and peripheral VLDL-TG clearance | - changes from baseline after treatment with either resveratrol or placebo | 1 month | 
| Hepatic and adipose VLDL-TG uptake | - changes in VLDL-TG uptake in resveratrol group and placebo group | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Basal and insulin stimulated free fatty acid (FFA) and glucose turnover | - changes from baseline after treatment with either resveratrol or placebo | 1 month | 
| VLDL-TG oxidation | - changes from baseline after treatment with either resveratrol or placebo | 1 month | 
| Regulation of liver fat handling | - changes in regulation of liver fat handling in resveratrol group and placebo group | 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obesity, Gastric bypass surgery, Resveratrol, Insulin sensitivity, Lipid turnover, VLDL-triglyceride uptake, Liver