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

Not Applicable

• Conditions: Obesity
• Interventions: Dietary Supplement: Resveratrol; Other: Placebo

• Registration Number: NCT01826279
• Lead Sponsor: University of Aarhus

Brief Summary

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)

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2013-04-03
• Study First Submitted QC: 2013-04-03
• Study First Posted: 2013-04-08
• Status Verified: 2013-05
• Study Start: 2013-05
• Last Update Submitted: 2014-01-29
• Last Update Posted: 2014-01-30
• Primary Completion: 2014-08
• Study Completion: 2014-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 16

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

Read More

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)

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Resveratrol	Resveratrol	Resveratrol 500mg 3 times daily for 1 month
Placebo	Placebo	Placebo 1 tablet 3 times daily for 1 month

Primary Outcome Measures

Name	Time	Method
Hepatic VLDL-TG secretion and peripheral VLDL-TG clearance	1 month	- changes from baseline after treatment with either resveratrol or placebo
Hepatic and adipose VLDL-TG uptake	1 month	- changes in VLDL-TG uptake in resveratrol group and placebo group

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Department of Endocrinology and Internal Medicine; 🇩🇰 Aarhus C, Denmark