Type 2 Diabetes MellitusPhase 2NCT01354977
Effect of Resveratrol on Age-related Insulin Resistance and Inflammation in Humans
A Phase 2 study testing Resveratrol in people with Type 2 Diabetes Mellitus and Insulin Resistance, run by Albert Einstein College of Medicine at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 45 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes Mellitus, Insulin Resistance
- What is being tested?
- Resveratrol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2008to 15 Sep 2017
- Phase
- Phase 2
- 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 45 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- BMI: 26-35
- Non-smoker
- Normal screening labs (CMC, chemistry, LFTs PT/PTT)
- No CAD
- Good IV access
Who cannot join
- 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
Show all 24Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Albert Einstein College of Medicine
The Bronx, New York, 10461
About this study
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.
Read the 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.
- Conditions
- Type 2 Diabetes Mellitus, Insulin Resistance
- Being tested
- Resveratrol
- Keywords
- Diabetes Mellitus, Type 2, Glucose Metabolism Disorders, Metabolic Diseases, Diabetes Mellitus, Endocrine System Diseases, Resveratrol, Therapeutic Uses
- Medical subject headings
- Diabetes Mellitus, Type 2, Insulin Resistance, Glucose Metabolism Disorders, Metabolic Diseases, Diabetes Mellitus, Endocrine System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ResveratrolDrug
Also called 3,5,4'-trihydroxy-trans-stilbene
1,000mg twice daily for 28 days
| Study group | Role | What they receive |
|---|---|---|
| Resveratrol | Experimental | Each participant will receive a 28 days' supply of resveratrol capsules on day 0. Receives: Drug: Resveratrol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 4 weeks
Secondary outcomes (4)
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).
Measured: 4 weeks
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.
Measured: 4 weeks
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
Measured: 4 weeks
Muscle Mitochondrial Area
Skeletal Muscle Mitochondria Area Before and After 4 Weeks of Resveratrol/Placebo Treatment
Measured: 4 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2011 (estimated)
- Study startMar 2008
- Primary completion15 Sep 2017
- Study completion15 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Albert Einstein College of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Meredith Hawkins, Albert Einstein College of Medicine
- Investigators
- Meredith A Hawkins, M.D., M.S., Principal investigator, Albert Einstein College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01354977
- Sponsor's protocol ID
- 2007-534
- Status last verified
- Feb 2022
- First submitted
- 12 May 2011
- Last updated
- 8 Mar 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Resveratrol on Age-related Insulin Resistance and Inflammation in Humans
- ClinicalTrials.gov ID
- NCT01354977
- Acronym / sponsor ID
- 2007-534
- Conditions
- Type 2 Diabetes Mellitus, Insulin Resistance
- Keywords
- Diabetes Mellitus, Type 2, Glucose Metabolism Disorders, Metabolic Diseases, Diabetes Mellitus, Endocrine System Diseases, Resveratrol, Therapeutic Uses
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Albert Einstein College of MedicineUniversity, hospital or other
- Study start
- Mar 2008 (actual)
- Primary completion
- 15 Sep 2017 (actual)
- Study completion
- 15 Sep 2017 (actual)
- First posted
- 17 May 2011 (estimated)
- Results
- Posted 8 Mar 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Resveratrol | Experimental | Drug: ResveratrolEach participant will receive a 28 days' supply of resveratrol capsules on day 0. |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- BMI: 26-35
- Non-smoker
- Normal screening labs (CMC, chemistry, LFTs PT/PTT)
- No CAD
- Good IV access
Key exclusion criteria (24 listed)
- High cholesterol
- <4 week history of participation in another drug trial
- Severe hypertension
- Heart disease
- Liver disease of liver abnormalities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ResveratrolAlso: 3,5,4'-trihydroxy-trans-stilbene1,000mg twice daily for 28 days | Drug | Resveratrol |
Primary outcome
Peripheral Insulin Sensitivity (RD) Measured by the Change in Glucose Rates of Disappearance With Resveratrol or Placebo at Baseline and at 4 Weeks.
Time frame: 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 secondary outcomes
Endogenous Glucose Production (EGP), With Resveratrol or Placebo at Baseline and at 4 Weeks.
Time frame: 4 weeks
Effects of Resveratrol on Skeletal Muscle Mitochondrial Numbers
Time frame: 4 weeks
Gene Expression in Whole Fat Tissue , Before and After 4 Weeks' Resveratrol and Placebo. Ratio From Baseline Versus at 4 Weeks
Time frame: 4 weeks
Muscle Mitochondrial Area
Time frame: 4 Weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Meredith A Hawkins, M.D., M.S. principal investigator
Albert Einstein College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Resveratrol in people with Type 2 Diabetes Mellitus and Insulin Resistance, 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 5 inclusion and 24 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 8 Mar 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Mar 2022). 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?
Peripheral Insulin Sensitivity (RD) Measured by the Change in Glucose Rates of Disappearance With Resveratrol or Placebo at Baseline and at 4 Weeks. (time frame: 4 weeks). 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 8 Mar 2022.