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

Obesity Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01826279
• Other study ID #: M-20110172B
• Status: Active, not recruiting
• Phase: N/A
• First received: April 3, 2013
• Last updated: January 29, 2014
• Start date: May 2013
• Est. completion date: August 2014

Study information

• Verified date: May 2013
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Regional Committee on Biomedical Research EthicsDenmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 16
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 25 Years to 60 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Obesity

Intervention

Dietary Supplement:
• Resveratrol
500mg 3 times daily for 1 month

Other:
• Placebo
1 placebo tablet 3 times daily for 1 month

Locations

Country	Name	City	State
Denmark	Department of Endocrinology and Internal Medicine	Aarhus C

Sponsors (2)

Lead Sponsor	Collaborator
University of Aarhus	The Ministry of Science, Technology and Innovation, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hepatic VLDL-TG secretion and peripheral VLDL-TG clearance	- changes from baseline after treatment with either resveratrol or placebo	1 month	No
Primary	Hepatic and adipose VLDL-TG uptake	- changes in VLDL-TG uptake in resveratrol group and placebo group	1 month	No
Secondary	Basal and insulin stimulated free fatty acid (FFA) and glucose turnover	- changes from baseline after treatment with either resveratrol or placebo	1 month	No
Secondary	VLDL-TG oxidation	- changes from baseline after treatment with either resveratrol or placebo	1 month	No
Secondary	Regulation of liver fat handling	- changes in regulation of liver fat handling in resveratrol group and placebo group	1 month	No

External Links

•   Official web page for the LIRMOI project, back ground info and contact