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Effect of Resveratrol on Age-related Insulin Resistance and Inflammation in Humans

Primary Purpose

Type 2 Diabetes Mellitus, Insulin Resistance

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Resveratrol
Sponsored by
Albert Einstein College of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus focused on measuring Diabetes Mellitus, Type 2, Glucose Metabolism Disorders, Metabolic Diseases, Diabetes Mellitus, Endocrine System Diseases, Resveratrol, Therapeutic Uses

Eligibility Criteria

45 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • BMI: 26-35
  • Non-smoker
  • Normal screening labs (CMC, chemistry, LFTs PT/PTT)
  • No CAD
  • Good IV access

Exclusion Criteria:

  • High cholesterol
  • <4 week history of participation in another drug trial
  • Severe hypertension
  • Heart disease
  • Liver disease of liver abnormalities
  • Cerebrovascular disease, i.e. stroke
  • CVD
  • Seizures
  • Bleeding disorders
  • Muscle disease
  • Cancer
  • HIV
  • Hepatitis (all types)
  • Mentally disabled persons
  • Pregnant women
  • Allergies to Novocaine, Lidocaine, Benzocaine

  • Subjects on the following medications:

    • Anticoagulant and antiplatelet drugs
    • Anti-epileptic drugs
    • Mexiletene
    • Quinidine
    • Cyclosporine
    • Tacrolimus
    • HIV protease inhibitors

Sites / Locations

  • Albert Einstein College of Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Resveratrol

Arm Description

Each participant will receive a 28 days' supply of resveratrol capsules on day 0.

Outcomes

Primary Outcome Measures

Peripheral Insulin Sensitivity (RD) Measured by the Change in Glucose Rates of Disappearance With Resveratrol or Placebo at Baseline and at 4 Weeks.
We will measure peripheral insulin sensitivity by determining the rate of glucose uptake (RD). RD will be measured using a 6 hours stepped pancreatic clamp study procedure under various treatment conditions (eg, resveratrol or placebo). by monitoring changes in the level of a non-radioactive, naturally occurring form of glucose (sugar).

Secondary Outcome Measures

Endogenous Glucose Production (EGP), With Resveratrol or Placebo at Baseline and at 4 Weeks.
Endogenous glucose production will be used to determine hepatic insulin sensitivity. Rates of EGP (a measure of the body's production of sugar) will be measured using a 6 hour stepped pancreatic clamp procedure under various treatment conditions (eg, resveratrol or placebo), by monitoring changes in the level of a non-radioactive, naturally occurring form of glucose (sugar).
Effects of Resveratrol on Skeletal Muscle Mitochondrial Numbers
Skeletal muscle mitochondria numbers were calculated under EM on subjects pre- and post- treatment of either Resveratrol or placebo intervention.
Gene Expression in Whole Fat Tissue , Before and After 4 Weeks' Resveratrol and Placebo. Ratio From Baseline Versus at 4 Weeks
Changes of relative copy number of gene inflammatory markers in whole fat tissue were studied by quantitative, real-time RT-PCR, resveratrol vs. placebo
Muscle Mitochondrial Area
Skeletal Muscle Mitochondria Area Before and After 4 Weeks of Resveratrol/Placebo Treatment

Full Information

First Posted
May 12, 2011
Last Updated
February 10, 2022
Sponsor
Albert Einstein College of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT01354977
Brief Title
Effect of Resveratrol on Age-related Insulin Resistance and Inflammation in Humans
Official Title
Effect of Resveratrol on Age-related Insulin Resistance and Inflammation in Humans
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
March 2008 (Actual)
Primary Completion Date
September 15, 2017 (Actual)
Study Completion Date
September 15, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Albert Einstein College of Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Resveratrol is a natural polyphenol (a compound containing a phenol functional group) that can be found in many plants. The purpose of this research is to study the effects of resveratrol on the action of insulin (a hormone produced in the body by the pancreas that regulates the amount of sugar in the blood), fat accumulation, and inflammation in the body.
Detailed Description
Participants will meet with the study team to discuss dietary recommendations. Each participant will be instructed to follow a standardized diet plan and to avoid vigorous exercise before beginning the study. Participants will be given a 28 day supply of resveratrol capsules (Two 500 mg capsules taken twice a day). A comprehensive study of whole-body insulin action called a pancreatic clamp will be done and small samples of fat and muscle will be taken before and after the administration of resveratrol.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus, Insulin Resistance
Keywords
Diabetes Mellitus, Type 2, Glucose Metabolism Disorders, Metabolic Diseases, Diabetes Mellitus, Endocrine System Diseases, Resveratrol, Therapeutic Uses

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Resveratrol
Arm Type
Experimental
Arm Description
Each participant will receive a 28 days' supply of resveratrol capsules on day 0.
Intervention Type
Drug
Intervention Name(s)
Resveratrol
Other Intervention Name(s)
3,5,4'-trihydroxy-trans-stilbene
Intervention Description
1,000mg twice daily for 28 days
Primary Outcome Measure Information:
Title
Peripheral Insulin Sensitivity (RD) Measured by the Change in Glucose Rates of Disappearance With Resveratrol or Placebo at Baseline and at 4 Weeks.
Description
We will measure peripheral insulin sensitivity by determining the rate of glucose uptake (RD). RD will be measured using a 6 hours stepped pancreatic clamp study procedure under various treatment conditions (eg, resveratrol or placebo). by monitoring changes in the level of a non-radioactive, naturally occurring form of glucose (sugar).
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Endogenous Glucose Production (EGP), With Resveratrol or Placebo at Baseline and at 4 Weeks.
Description
Endogenous glucose production will be used to determine hepatic insulin sensitivity. Rates of EGP (a measure of the body's production of sugar) will be measured using a 6 hour stepped pancreatic clamp procedure under various treatment conditions (eg, resveratrol or placebo), by monitoring changes in the level of a non-radioactive, naturally occurring form of glucose (sugar).
Time Frame
4 weeks
Title
Effects of Resveratrol on Skeletal Muscle Mitochondrial Numbers
Description
Skeletal muscle mitochondria numbers were calculated under EM on subjects pre- and post- treatment of either Resveratrol or placebo intervention.
Time Frame
4 weeks
Title
Gene Expression in Whole Fat Tissue , Before and After 4 Weeks' Resveratrol and Placebo. Ratio From Baseline Versus at 4 Weeks
Description
Changes of relative copy number of gene inflammatory markers in whole fat tissue were studied by quantitative, real-time RT-PCR, resveratrol vs. placebo
Time Frame
4 weeks
Title
Muscle Mitochondrial Area
Description
Skeletal Muscle Mitochondria Area Before and After 4 Weeks of Resveratrol/Placebo Treatment
Time Frame
4 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: BMI: 26-35 Non-smoker Normal screening labs (CMC, chemistry, LFTs PT/PTT) No CAD Good IV access Exclusion Criteria: High cholesterol <4 week history of participation in another drug trial Severe hypertension Heart disease Liver disease of liver abnormalities Cerebrovascular disease, i.e. stroke CVD Seizures Bleeding disorders Muscle disease Cancer HIV Hepatitis (all types) Mentally disabled persons Pregnant women Allergies to Novocaine, Lidocaine, Benzocaine Subjects on the following medications: Anticoagulant and antiplatelet drugs Anti-epileptic drugs Mexiletene Quinidine Cyclosporine Tacrolimus HIV protease inhibitors
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Meredith A Hawkins, M.D., M.S.
Organizational Affiliation
Albert Einstein College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Albert Einstein College of Medicine
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Effect of Resveratrol on Age-related Insulin Resistance and Inflammation in Humans

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