NCT01354977

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for phase_2 type-2-diabetes-mellitus

Timeline
Completed

Started Mar 2008

Longer than P75 for phase_2 type-2-diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

March 1, 2008

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

May 12, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 17, 2011

Completed
6.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2017

Completed
4.5 years until next milestone

Results Posted

Study results publicly available

March 8, 2022

Completed
Last Updated

March 8, 2022

Status Verified

February 1, 2022

Enrollment Period

9.5 years

First QC Date

May 12, 2011

Results QC Date

July 19, 2021

Last Update Submit

February 10, 2022

Conditions

Type 2 Diabetes MellitusInsulin Resistance

Keywords

Diabetes Mellitus, Type 2Glucose Metabolism DisordersMetabolic DiseasesDiabetes MellitusEndocrine System DiseasesResveratrolTherapeutic Uses

Outcome Measures

Primary Outcomes (1)

  • 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).

    4 weeks

Secondary Outcomes (4)

  • Endogenous Glucose Production (EGP), With Resveratrol or Placebo at Baseline and at 4 Weeks.

    4 weeks

  • Effects of Resveratrol on Skeletal Muscle Mitochondrial Numbers

    4 weeks

  • Gene Expression in Whole Fat Tissue , Before and After 4 Weeks' Resveratrol and Placebo. Ratio From Baseline Versus at 4 Weeks

    4 weeks

  • Muscle Mitochondrial Area

    4 Weeks

Study Arms (1)

Resveratrol

EXPERIMENTAL

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

Drug: Resveratrol

Interventions

ResveratrolDRUG

1,000mg twice daily for 28 days

Also known as: 3,5,4'-trihydroxy-trans-stilbene
Resveratrol

Eligibility Criteria

Age45 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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
  • +9 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Albert Einstein College of Medicine

The Bronx, New York, 10461, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Insulin ResistanceGlucose Metabolism DisordersMetabolic DiseasesDiabetes MellitusEndocrine System Diseases

Interventions

Resveratrol

Condition Hierarchy (Ancestors)

Nutritional and Metabolic DiseasesHyperinsulinism

Intervention Hierarchy (Ancestors)

StilbestrolsStilbenesBenzylidene CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolyphenolsPhenols

Results Point of Contact

Title
Dr. Meredith Hawkins
Organization
Albert Einstein College of Medicine
meredith.hawkins@einstein.yu.edu
7184302903

Study Officials

  • Meredith A Hawkins, M.D., M.S.

    Albert Einstein College of Medicine

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 12, 2011

First Posted

May 17, 2011

Study Start

March 1, 2008

Primary Completion

September 15, 2017

Study Completion

September 15, 2017

Last Updated

March 8, 2022

Results First Posted

March 8, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)