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

NCT ID: NCT01826279

Last Updated: 2014-01-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-31

Study Completion Date

2014-08-31

Brief Summary

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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

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Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Resveratrol

Resveratrol 500mg 3 times daily for 1 month

Group Type EXPERIMENTAL

Resveratrol

Intervention Type DIETARY_SUPPLEMENT

500mg 3 times daily for 1 month

Placebo

Placebo 1 tablet 3 times daily for 1 month

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

1 placebo tablet 3 times daily for 1 month

Interventions

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Resveratrol

500mg 3 times daily for 1 month

Intervention Type DIETARY_SUPPLEMENT

Placebo

1 placebo tablet 3 times daily for 1 month

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

25 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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The Ministry of Science, Technology and Innovation, Denmark

OTHER_GOV

Sponsor Role collaborator

University of Aarhus

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Søren Nielsen, MD, associate professor, DMSc

Role: STUDY_CHAIR

Department of Endocrinology and Internal Medicine

Locations

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Department of Endocrinology and Internal Medicine

Aarhus C, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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M-20110172B

Identifier Type: -

Identifier Source: org_study_id

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