Overview

This trial is active, not recruiting.

Condition obesity
Treatments resveratrol, placebo
Sponsor University of Aarhus
Collaborator The Ministry of Science, Technology and Innovation, Denmark
Start date May 2013
End date August 2014
Trial size 16 participants
Trial identifier NCT01826279, M-20110172B

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)

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, outcomes assessor)
Primary purpose basic science
Arm
(Experimental)
Resveratrol 500mg 3 times daily for 1 month
resveratrol Resveratrol
500mg 3 times daily for 1 month
(Placebo Comparator)
Placebo 1 tablet 3 times daily for 1 month
placebo Placebo
1 placebo tablet 3 times daily for 1 month

Primary Outcomes

Measure
Hepatic VLDL-TG secretion and peripheral VLDL-TG clearance
time frame: 1 month
Hepatic and adipose VLDL-TG uptake
time frame: 1 month

Secondary Outcomes

Measure
Basal and insulin stimulated free fatty acid (FFA) and glucose turnover
time frame: 1 month
VLDL-TG oxidation
time frame: 1 month
Regulation of liver fat handling
time frame: 1 month

Eligibility Criteria

Female participants from 25 years up to 60 years old.

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)

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in January 2014.
Information provided to ClinicalTrials.gov by University of Aarhus.