Clinical trial NCT01826279: Short-term Investigation of Resveratrol on Fat Metabolism in Morbidly Obese Women Undergoing Gastric Bypass Surgery
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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obesity
Keywords: Obesity
Gastric bypass surgery
Resveratrol
Insulin sensitivity
Lipid turnover
VLDL-triglyceride uptake
Liver
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: The Ministry of Science, Technology and Innovation, Denmark
First posted: 2013-04-08
Enrollment: 16
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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)


Eligibility criteria: 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)

Primary outcomes:
measure: Hepatic VLDL-TG secretion and peripheral VLDL-TG clearance
timeFrame: 1 month
measure: Hepatic and adipose VLDL-TG uptake
timeFrame: 1 month
Secondary outcomes:
measure: Basal and insulin stimulated free fatty acid (FFA) and glucose turnover
timeFrame: 1 month
measure: VLDL-TG oxidation
timeFrame: 1 month
measure: Regulation of liver fat handling
timeFrame: 1 month
Other outcomes:
Locations:
city: Aarhus C
country: Denmark
facility: Department of Endocrinology and Internal Medicine
Study officials:
affiliation: Department of Endocrinology and Internal Medicine
name: Søren Nielsen, MD, associate professor, DMSc
role: STUDY_CHAIR
References: