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Resveratrol and Type 2 Diabetes

Primary Purpose

Type 2 Diabetes

Status
Unknown status
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
placebo
resveratrol
Sponsored by
Maastricht University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Male sex
  • Age: 40-70 years
  • Body fat percentage > 25, BMI 27-35 kg/m2
  • Diagnosed with type 2 diabetes at least one year before the start of the study
  • Well-controlled type 2 diabetics: HBA1C < 8.0%
  • Oral glucose lowering medication (metformin only or in combination with sulfonylurea agents)

  • Sedentary

    • Not more than 2 hours of sports a week
    • No active job that requires strenuous physical activity
  • Stable dietary habits
  • Willingness to abstain from resveratrol-containing food products

Exclusion Criteria:

  • Unstable body weight (weight gain or loss > 3kg in the last three months)
  • Total body fat percentage < 25%
  • Hemoglobin < 7.8 mmol/l
  • Use of anticoagulants
  • Engagement in programmed exercise > 2 hours total per week
  • Impaired kidney and/or hepatic function Creatinine 50-100 umol/L Liver enzymes, within 2 times of normal range of laboratory standard (ASAT < 60 U/L, ALAT < 70 U/L, Billi <40 umol/L, gamma-GT < 80 U/L)
  • No diabetes related co-morbidities like cardiovascular diseases, diabetic foot, polyneuropathy, retinopathy
  • Insulin dependent Diabetic subjects
  • Any medical condition except type 2 diabetes mellitus requiring treatment and/or medication use except metformin only or in combination with sulfonylurea agents
  • Intake of dietary supplements except multivitamins and minerals
  • Current alcohol consumption > 20 grams/day
  • Subjects who don't want to be informed about unexpected medical findings during the screening /study, or do not wish that their physician is informed, cannot participate in the study.
  • Participation in another biomedical study within 1 month before the first screening visit

  • Any contraindication to MRI scanning. These contra-indications include patients with following devices:

    • Central nervous system aneurysm clip
    • Implanted neural stimulator
    • Implanted cardiac pacemaker of defibrillator
    • Cochlear implant
    • Insulin pump
    • Or metal containing corpora aliena in the eye or brains

Sites / Locations

  • Maastricht University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

placebo

resveratrol

Arm Description

A placebo will be given for 30 days, twice daily. One pill will be provided with lunch and the other pill will be provided with dinner.

resveratrol will be given for 30 days, twice daily. One pill, which contains 75 mg of resveratrol, will be provided with lunch, and the other pill of 75 mg will be provided with dinner. So in total 150 mg/day of resveratrol will be given.

Outcomes

Primary Outcome Measures

insulin sensitivity (overall, muscle- and liver specific)

Secondary Outcome Measures

muscle mitochondrial oxidative capacity
intramyocellular lipid content
intrahepatic lipid content
intracardiac lipid content
heart function

Full Information

First Posted
May 30, 2012
Last Updated
September 3, 2014
Sponsor
Maastricht University Medical Center
Collaborators
DSM Nutritional Products, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01638780
Brief Title
Resveratrol and Type 2 Diabetes
Official Title
Effect of Resveratrol on Insulin Sensitivity and Metabolic Profile in Type 2 Diabetics
Study Type
Interventional

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Unknown status
Study Start Date
May 2012 (undefined)
Primary Completion Date
September 2014 (Anticipated)
Study Completion Date
December 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Maastricht University Medical Center
Collaborators
DSM Nutritional Products, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The main objective of the study is to investigate if resveratrol supplementation can improve overall and muscle-specific insulin sensitivity in type 2 diabetic patients. As a secondary objective the investigators want to investigate whether the improved insulin sensitivity can be attributed to improved muscle mitochondrial oxidative capacity and a reduced intrahepatic and cardiac lipid content.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
A placebo will be given for 30 days, twice daily. One pill will be provided with lunch and the other pill will be provided with dinner.
Arm Title
resveratrol
Arm Type
Active Comparator
Arm Description
resveratrol will be given for 30 days, twice daily. One pill, which contains 75 mg of resveratrol, will be provided with lunch, and the other pill of 75 mg will be provided with dinner. So in total 150 mg/day of resveratrol will be given.
Intervention Type
Dietary Supplement
Intervention Name(s)
placebo
Intervention Description
A placebo will given for 30 days, twice daily. One pill will be provided with lunch, and the other pill will be provided with dinner.
Intervention Type
Dietary Supplement
Intervention Name(s)
resveratrol
Other Intervention Name(s)
resVida (99% pure trans-resveratrol) provided by DSM Nutritional Products, Ltd.
Intervention Description
resveratrol will be given for 30 days, twice daily. One pill, which contains 75 mg of resveratrol, will be provided with lunch, and the other pill, also containing 75 mg will be given with dinner. So in total a dose of 150 mg/day will be given.
Primary Outcome Measure Information:
Title
insulin sensitivity (overall, muscle- and liver specific)
Time Frame
30 days after supplementation
Secondary Outcome Measure Information:
Title
muscle mitochondrial oxidative capacity
Time Frame
30 days after supplementation
Title
intramyocellular lipid content
Time Frame
30 days after supplementation
Title
intrahepatic lipid content
Time Frame
30 days after supplementation
Title
intracardiac lipid content
Time Frame
30 days after supplementation
Title
heart function
Time Frame
30 days after supplementation

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male sex Age: 40-70 years Body fat percentage > 25, BMI 27-35 kg/m2 Diagnosed with type 2 diabetes at least one year before the start of the study Well-controlled type 2 diabetics: HBA1C < 8.0% Oral glucose lowering medication (metformin only or in combination with sulfonylurea agents) Sedentary Not more than 2 hours of sports a week No active job that requires strenuous physical activity Stable dietary habits Willingness to abstain from resveratrol-containing food products Exclusion Criteria: Unstable body weight (weight gain or loss > 3kg in the last three months) Total body fat percentage < 25% Hemoglobin < 7.8 mmol/l Use of anticoagulants Engagement in programmed exercise > 2 hours total per week Impaired kidney and/or hepatic function Creatinine 50-100 umol/L Liver enzymes, within 2 times of normal range of laboratory standard (ASAT < 60 U/L, ALAT < 70 U/L, Billi <40 umol/L, gamma-GT < 80 U/L) No diabetes related co-morbidities like cardiovascular diseases, diabetic foot, polyneuropathy, retinopathy Insulin dependent Diabetic subjects Any medical condition except type 2 diabetes mellitus requiring treatment and/or medication use except metformin only or in combination with sulfonylurea agents Intake of dietary supplements except multivitamins and minerals Current alcohol consumption > 20 grams/day Subjects who don't want to be informed about unexpected medical findings during the screening /study, or do not wish that their physician is informed, cannot participate in the study. Participation in another biomedical study within 1 month before the first screening visit Any contraindication to MRI scanning. These contra-indications include patients with following devices: Central nervous system aneurysm clip Implanted neural stimulator Implanted cardiac pacemaker of defibrillator Cochlear implant Insulin pump Or metal containing corpora aliena in the eye or brains
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Silvie Timmers, PhD
Organizational Affiliation
Human Biology, Maastricht University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maastricht University Medical Center
City
Maastricht
State/Province
Limburg
ZIP/Postal Code
6200MD
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
22055504
Citation
Timmers S, Konings E, Bilet L, Houtkooper RH, van de Weijer T, Goossens GH, Hoeks J, van der Krieken S, Ryu D, Kersten S, Moonen-Kornips E, Hesselink MKC, Kunz I, Schrauwen-Hinderling VB, Blaak E, Auwerx J, Schrauwen P. Calorie restriction-like effects of 30 days of resveratrol supplementation on energy metabolism and metabolic profile in obese humans. Cell Metab. 2011 Nov 2;14(5):612-22. doi: 10.1016/j.cmet.2011.10.002.
Results Reference
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Resveratrol and Type 2 Diabetes

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