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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
The Ministry of Science, Technology and Innovation, Denmark
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT01826279
First received: April 3, 2013
Last updated: January 29, 2014
Last verified: May 2013
  Purpose

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)

Condition Intervention
Obesity
Dietary Supplement: Resveratrol
Other: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Basic Science
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.

Resource links provided by NLM:


Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • Hepatic VLDL-TG secretion and peripheral VLDL-TG clearance [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    - changes from baseline after treatment with either resveratrol or placebo

  • Hepatic and adipose VLDL-TG uptake [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    - 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 [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    - changes from baseline after treatment with either resveratrol or placebo

  • VLDL-TG oxidation [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    - changes from baseline after treatment with either resveratrol or placebo

  • Regulation of liver fat handling [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    - changes in regulation of liver fat handling in resveratrol group and placebo group


Estimated Enrollment: 16
Study Start Date: May 2013
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Resveratrol
Resveratrol 500mg 3 times daily for 1 month
Dietary Supplement: Resveratrol
500mg 3 times daily for 1 month
Other Name: Resveratrol
Placebo Comparator: Placebo
Placebo 1 tablet 3 times daily for 1 month
Other: Placebo
1 placebo tablet 3 times daily for 1 month
Other Name: Placebo

  Eligibility

Ages Eligible for Study:   25 Years to 60 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01826279

Locations
Denmark
Department of Endocrinology and Internal Medicine
Aarhus C, Denmark, 8000
Sponsors and Collaborators
University of Aarhus
The Ministry of Science, Technology and Innovation, Denmark
Investigators
Study Chair: Søren Nielsen, MD, associate professor, DMSc Department of Endocrinology and Internal Medicine
  More Information

Additional Information:
No publications provided

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01826279     History of Changes
Other Study ID Numbers: M-20110172B
Study First Received: April 3, 2013
Last Updated: January 29, 2014
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics
Denmark: Danish Dataprotection Agency

Keywords provided by University of Aarhus:
Obesity
Gastric bypass surgery
Resveratrol
Insulin sensitivity
Lipid turnover
VLDL-triglyceride uptake
Liver

Additional relevant MeSH terms:
Resveratrol
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Enzyme Inhibitors
Platelet Aggregation Inhibitors
Hematologic Agents
Antimutagenic Agents
Anticarcinogenic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on April 14, 2014