Suspended

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.

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What is being tested

Resveratrol

+ Placebo

Dietary SupplementOther
Who is being recruted

Body Weight+9

+ Hyperinsulinism

+ Metabolic Diseases

From 25 to 60 Years
+13 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Basic Science Study

Placebo-Controlled
Interventional
Study Start: May 2013
See protocol details

Summary

Principal SponsorUniversity of Aarhus
Last updated: January 30, 2014
Sourced from a government-validated database.Claim as a partner

Study start date: May 1, 2013

Actual date on which the first participant was enrolled.

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)

NCT01826279
Principal SponsorUniversity of Aarhus
Last updated: January 30, 2014
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

16 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Basic Science Study

Basic science studies help researchers understand how the body works or how a disease develops. They don't test treatments, but they build the foundation for future therapies.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Female

Biological sex of participants that are eligible to enroll.

From 25 to 60 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Body WeightHyperinsulinismMetabolic DiseasesNutrition DisordersNutritional and Metabolic DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsOvernutritionGlucose Metabolism DisordersOverweightInsulin ResistanceObesity

Criteria

6 inclusion criteria required to participate
25-60 years
Female
Have at least one element of the metabolic syndrome either hypertension and/or hypercholesterolemia (high triglyceride, low HDL-cholesterol)
Obesity (BMI > 35 kg/m2)
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7 exclusion criteria prevent from participating
Alcohol dependency (more than 14 units of alcohol per week)
Any other relevant disease (e.g. diabetes, thyroid or parathyroid disease, heart, kidney or liver disease)
Any present or previous malignancy
Hemoglobin under the normal range regarding to sex (under 7.3 mmol/l for women)
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
Resveratrol 500mg 3 times daily for 1 month

Group II

Placebo
Placebo 1 tablet 3 times daily for 1 month

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Department of Endocrinology and Internal Medicine

Aarhus C, DenmarkOpen Department of Endocrinology and Internal Medicine in Google Maps
SuspendedOne Study Center