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

Type 2 Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01354977
• Other study ID #: 2007-534
• Status: Completed
• Phase: Phase 2
• Start date: March 2008
• Est. completion date: September 15, 2017

Study information

• Verified date: February 2022
• Source: Albert Einstein College of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 accumulation, and inflammation in the body.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: September 15, 2017
• Est. primary completion date: September 15, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Inflammation
• Insulin Resistance
• Type 2 Diabetes Mellitus

Intervention

Drug:
• Resveratrol
1,000mg twice daily for 28 days

Locations

Country	Name	City	State
United States	Albert Einstein College of Medicine	Bronx	New York

Sponsors (1)

Lead Sponsor	Collaborator
Albert Einstein College of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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).	4 weeks
Secondary	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.	4 weeks
Secondary	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	4 weeks
Secondary	Muscle Mitochondrial Area	Skeletal Muscle Mitochondria Area Before and After 4 Weeks of Resveratrol/Placebo Treatment	4 Weeks