Phase 2 N=20 Treatment

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

Type 2 Diabetes Mellitus · Insulin Resistance

Bottom Line

View on ClinicalTrials.gov: NCT01354977 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Mar 2022

Primary outcome: Primary: Peripheral Insulin Sensitivity (RD) Measured by the Change in Glucose Rates of Disappearance With Resveratrol or Placebo at Baseline and at 4 Weeks. — 6.573; 7.272; 8.445; 7.419 mg/kg/min

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Resveratrol (Drug)
Age: Adult, Older Adult · 45+ yrs
Sex: All
Sponsor: Albert Einstein College of Medicine
Primary completion: Sep 2017

Outcome Measures

Outcome	Result	p-value
PRIMARY Peripheral Insulin Sensitivity (RD) Measured by the Change in Glucose Rates of Disappearance With Resveratrol or Placebo at Baseline and at 4 Weeks.	6.573; 7.272; 8.445; 7.419	—
SECONDARY Endogenous Glucose Production (EGP), With Resveratrol or Placebo at Baseline and at 4 Weeks.	1.014; 0.903; 1.140; 1.552	—
SECONDARY Effects of Resveratrol on Skeletal Muscle Mitochondrial Numbers	48.489; 41.275; 46.622; 48.850	—
SECONDARY Gene Expression in Whole Fat Tissue , Before and After 4 Weeks' Resveratrol and Placebo. Ratio From Baseline Versus at 4 Weeks	0.47; 1.4; 1.84; 1.68; 0.56; 0.76	—
SECONDARY Muscle Mitochondrial Area	0.070; 0.080; 0.098; 0.102	—

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01354977). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.