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

Primary Purpose

Obesity

Status
Unknown status
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Resveratrol
Placebo
Sponsored by
University of Aarhus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Obesity focused on measuring Obesity, Gastric bypass surgery, Resveratrol, Insulin sensitivity, Lipid turnover, VLDL-triglyceride uptake, Liver

Eligibility Criteria

25 Years - 60 Years (Adult)FemaleDoes not accept healthy volunteers

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)

Sites / Locations

  • Department of Endocrinology and Internal Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Resveratrol

Placebo

Arm Description

Resveratrol 500mg 3 times daily for 1 month

Placebo 1 tablet 3 times daily for 1 month

Outcomes

Primary Outcome Measures

Hepatic VLDL-TG secretion and peripheral VLDL-TG clearance
- changes from baseline after treatment with either resveratrol or placebo
Hepatic and adipose VLDL-TG uptake
- changes in VLDL-TG uptake in resveratrol group and placebo group

Secondary Outcome Measures

Basal and insulin stimulated free fatty acid (FFA) and glucose turnover
- changes from baseline after treatment with either resveratrol or placebo
VLDL-TG oxidation
- changes from baseline after treatment with either resveratrol or placebo
Regulation of liver fat handling
- changes in regulation of liver fat handling in resveratrol group and placebo group

Full Information

First Posted
April 3, 2013
Last Updated
January 29, 2014
Sponsor
University of Aarhus
Collaborators
The Ministry of Science, Technology and Innovation, Denmark
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1. Study Identification

Unique Protocol Identification Number
NCT01826279
Brief Title
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

2. Study Status

Record Verification Date
May 2013
Overall Recruitment Status
Unknown status
Study Start Date
May 2013 (undefined)
Primary Completion Date
August 2014 (Anticipated)
Study Completion Date
August 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus
Collaborators
The Ministry of Science, Technology and Innovation, Denmark

4. Oversight

Data Monitoring Committee
No

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
Obesity, Gastric bypass surgery, Resveratrol, Insulin sensitivity, Lipid turnover, VLDL-triglyceride uptake, Liver

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
16 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Resveratrol
Arm Type
Experimental
Arm Description
Resveratrol 500mg 3 times daily for 1 month
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo 1 tablet 3 times daily for 1 month
Intervention Type
Dietary Supplement
Intervention Name(s)
Resveratrol
Intervention Description
500mg 3 times daily for 1 month
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
1 placebo tablet 3 times daily for 1 month
Primary Outcome Measure Information:
Title
Hepatic VLDL-TG secretion and peripheral VLDL-TG clearance
Description
- changes from baseline after treatment with either resveratrol or placebo
Time Frame
1 month
Title
Hepatic and adipose VLDL-TG uptake
Description
- changes in VLDL-TG uptake in resveratrol group and placebo group
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Basal and insulin stimulated free fatty acid (FFA) and glucose turnover
Description
- changes from baseline after treatment with either resveratrol or placebo
Time Frame
1 month
Title
VLDL-TG oxidation
Description
- changes from baseline after treatment with either resveratrol or placebo
Time Frame
1 month
Title
Regulation of liver fat handling
Description
- changes in regulation of liver fat handling in resveratrol group and placebo group
Time Frame
1 month

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Søren Nielsen, MD, associate professor, DMSc
Organizational Affiliation
Department of Endocrinology and Internal Medicine
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Endocrinology and Internal Medicine
City
Aarhus C
ZIP/Postal Code
8000
Country
Denmark

12. IPD Sharing Statement

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

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