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Impaired Glucose ToleranceRSVNCT01375959

Pilot Study of Resveratrol in Older Adults With Impaired Glucose Tolerance

A study testing resveratrol in people with Impaired Glucose Tolerance, run by Albert Einstein College of Medicine at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Resveratrol is a substance found in many plants, including grapes and red wine, which is widely used as a nutritional supplement. Studies in cells and lower animals show that resveratrol has many potential benefits, including prolonging lifespan, preventing cancer and heart disease and normalization of glucose… Read more about this study

Who is it for?
Ages 50 to 80 years
Conditions the study is for
Impaired Glucose Tolerance
What is being tested?
resveratrol
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
38 participants
Where
1 siteUnited States
Study dates
Apr 2011to Apr 2015
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • impaired glucose tolerance

Who cannot join

  • history of estrogen-dependent neoplasm
  • use of certain drugs: high dose statins, warfarin, antiepileptics
  • current treatment with anti-diabetes medications
  • impaired liver or kidney function

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Albert Einstein College of Medicine of Yeshiva University

    The Bronx, New York, 10461

Other trials in United States

About this study

Official title: The Effect of Resveratrol in Older Adults With Impaired Glucose Tolerance: a Double-Blind Crossover Study

Resveratrol is a substance found in many plants, including grapes and red wine, which is widely used as a nutritional supplement. Studies in cells and lower animals show that resveratrol has many potential benefits, including prolonging lifespan, preventing cancer and heart disease and normalization of glucose metabolism. Although use of this agent shows great promise in the treatment and/or prevention of diabetes, there have been no studies reported to date in humans. As an initial step, this proposal is for a 6 week pilot study of resveratrol treatment in older adults with impaired glucose tolerance (IGT) in order to explore its effects on post-meal blood glucose metabolism. Preliminary studies will also be conducted to explore how resveratrol works by studying cellular function (in muscle samples obtained from study participants) and by testing resveratrol's effect on blood vessel function.

Read the detailed description
  1. Introduction and Specific Aims Resveratrol (RSV), a plant-derived polyphenol and potential activator of the mammalian sirtuin, Sirt1, has demonstrated promising effects on insulin secretion, insulin sensitivity and glucose tolerance and has extended the lifespan of obese mice. RSV is in common use as a nutritional supplement, but formal studies in humans are limited and-in particular-the metabolic effects of RSV in humans have yet to be carefully tested. The convergence of a worldwide epidemic of diabetes combined with a marked increase in the proportion of the elderly underscore the need to develop new approaches to improve glucose intolerance. We therefore propose a study of RSV treatment in older subjects with impaired glucose tolerance (IGT) to determine if there is improvement in glucose tolerance and markers of insulin resistance, mitochondrial biogenesis and vascular function. This proposal builds on our findings in a recently-completed NIH P01 on cardiovascular disease markers in older adults with IGT. It is our hypothesis that RSV has the potential to exert important metabolic effects that can be directly and safely tested in human subjects. The growing body of pre-clinical evidence, as well as our own preliminary data, provide strong support for formal tests of RSV effects on several important metabolic parameters. These proposed studies constitute a critical step in investigating the therapeutic potential of RSV, as well as providing insight into relevant mechanisms.

Specific Aims: We propose a 6-week randomized, double-blind, placebo controlled cross-over study of RSV in older adults (age 50-80 years, n=38) with IGT, with the following aims:

Specific Aim 1: To assess the effects of RSV (2g/day) on mixed meal tolerance in subjects with age-related glucose intolerance. In our previous studies, we developed a standard mixed meal protocol to evaluate postprandial changes in glucose, insulin and lipids. We will apply this protocol to study a cohort of older adults with impaired glucose tolerance in a double-blind, placebo controlled cross-over study of RSV treatment. Metabolic outcomes will include post-meal glucose area under the curve (AUC), calculated estimates of insulin sensitivity and insulin secretion and circulating levels of free fatty acids and triglycerides. This study will be the first to document RSV effects on glucose intolerance in humans and will provide critical information needed to inform future clinical and mechanistic investigations. We hypothesize that treatment with RSV will result in improvement in mixed meal tolerance, via effects on insulin secretion, insulin action or both, in subjects with age-related glucose intolerance.

Specific Aim 2: To assess the effects of RSV on age-related decline in mitochondrial biogenesis. In animal models, RSV has been shown to enhance mitochondrial biogenesis, which may occur through activation of Sirt1, which is an important regulator of cellular energy metabolism via PGC-1α (peroxisome-proliferator-activated receptor-γ coactivator-1 alpha). We will assess this directly by measuring mitochondrial mRNA expression and DNA copy number in muscle obtained from participants after treatment with RSV compared with placebo. Studies of mitochondrial morphology and enzyme activity will be performed in collaboration with Dr. Sreekumaran Nair (Mayo Clinic), who is an expert in mitochondrial physiology. We hypothesize that treatment with RSV will result in improvement in mitochondrial number and function, which is a potential mechanism for improvement in insulin sensitivity that may occur with RSV treatment.

Specific Aim 3: To assess the effects of RSV on fasting and post-meal endothelial function. Since treatment with RSV has also been reported to have beneficial cardiovascular effects, including improved vascular reactivity, we will study in vivo endothelial function. We will use reactive hyperemia peripheral arterial tonometry to assess endothelial dependent vasodilation in study subjects before and after treatment with RSV, in both the fasting and postprandial state. Augmentation index, a measure of arterial stiffness will also be assessed. We hypothesize that chronic treatment with RSV will result in improvement in endothelial function through direct vascular effects, which may be mediated via enhanced nitric oxide availability, reduced oxidative stress and/or as a consequence of improvement in glucose metabolism.

Being tested
resveratrol, Placebo
Keywords
resveratrol, glucose intolerance, insulin resistance, endothelial function
Medical subject headings
Glucose Intolerance, Insulin Resistance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • resveratrolDietary supplement

    Also called RevGenetics, X500 Resveratrol

    resveratrol 500 mg capsules, 3 capsules (1500 mg) orally twice a day for 6 weeks

  • PlaceboDrug

    3 placebo capsules orally twice a day for 6 weeks

Study groups in NCT01375959
Study groupRoleWhat they receive
ResveratrolExperimentalresveratrol 500 mg capsules, 3 each day for 6 weeks
Receives: Dietary Supplement: resveratrol
PlaceboPlacebo comparatormatching placebo capsule containing lactose, 3 each day for 6 weeks
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Post Meal Glucose Area Under the Curve

    Glucose AUC following a standard mixed meal challenge AUC, Area Under a Curve. There are no "normal ranges" but a higher value is worse than a lower value.

    Measured: end of each of two 6 week treatment periods

Secondary outcomes (1)
  1. Insulin Sensitivity Using a Modification of the Matsuda Index

    Insulin sensitivity was measured from insulin and glucose levels obtained following standard meal challenge using a modification of the Matsuda index. This was calculated based on data obtained from a 75 g oral glucose tolerance test, as follows: 10,000 divided by the square root of {(fasting plasma glucose X fasting plasma insulin) (mean plasma glucose X mean plasma insulin)}. This is a unitless measure.

    The Matsuda index is considered an early biomarker for metabolic dysregulation and is an effective clinical tool to define insulin sensitivity (i.e., the ability of tissues to respond to the signal of insulin) and secretory defects in individuals with impaired glucose homeostasis. The Matsuda index correlates strongly with the euglycemic insulin clamp which is a direct measure of insulin sensitivity. In the United States, it is recognized that participants who do not have insulin resistance have Matsuda Index values of >=2.5.

    Measured: end of each of two 6 week treatment periods

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jun 2011 (estimated)
  2. Study startApr 2011
  3. Primary completionApr 2014
  4. Study completionApr 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
38 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01375959
Sponsor's protocol ID
2010-398
Acronym
RSV
Status last verified
Sep 2022
First submitted
12 May 2011
Last updated
26 Oct 2022
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing resveratrol in people with Impaired Glucose Tolerance, run by Albert Einstein College of Medicine at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Aug 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Post Meal Glucose Area Under the Curve (time frame: end of each of two 6 week treatment periods). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2022.

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