NCT01826279

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)

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
16

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started May 2013

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 3, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 8, 2013

Completed
23 days until next milestone

Study Start

First participant enrolled

May 1, 2013

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
Last Updated

January 30, 2014

Status Verified

May 1, 2013

Enrollment Period

1.3 years

First QC Date

April 3, 2013

Last Update Submit

January 29, 2014

Conditions

Obesity

Keywords

ObesityGastric bypass surgeryResveratrolInsulin sensitivityLipid turnoverVLDL-triglyceride uptakeLiver

Outcome Measures

Primary Outcomes (2)

  • Hepatic VLDL-TG secretion and peripheral VLDL-TG clearance

    \- changes from baseline after treatment with either resveratrol or placebo

    1 month

  • Hepatic and adipose VLDL-TG uptake

    \- changes in VLDL-TG uptake in resveratrol group and placebo group

    1 month

Secondary Outcomes (3)

  • Basal and insulin stimulated free fatty acid (FFA) and glucose turnover

    1 month

  • VLDL-TG oxidation

    1 month

  • Regulation of liver fat handling

    1 month

Study Arms (2)

Resveratrol

EXPERIMENTAL

Resveratrol 500mg 3 times daily for 1 month

Dietary Supplement: Resveratrol

Placebo

PLACEBO COMPARATOR

Placebo 1 tablet 3 times daily for 1 month

Other: Placebo

Interventions

ResveratrolDIETARY_SUPPLEMENT

500mg 3 times daily for 1 month

Resveratrol
PlaceboOTHER

1 placebo tablet 3 times daily for 1 month

Placebo

Eligibility Criteria

Age25 Years - 60 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Female
  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Endocrinology and Internal Medicine

Aarhus C, 8000, Denmark

Location

MeSH Terms

Conditions

ObesityInsulin Resistance

Interventions

Resveratrol

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsHyperinsulinismGlucose Metabolism DisordersMetabolic Diseases

Intervention Hierarchy (Ancestors)

StilbestrolsStilbenesBenzylidene CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolyphenolsPhenols

Study Officials

  • Søren Nielsen, MD, associate professor, DMSc

    Department of Endocrinology and Internal Medicine

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 3, 2013

First Posted

April 8, 2013

Study Start

May 1, 2013

Primary Completion

August 1, 2014

Study Completion

August 1, 2014

Last Updated

January 30, 2014

Record last verified: 2013-05

Locations

DK(1)