Resveratrol in Type2 Diabetes and Obesity

NCT01158417 | Terminated

• 1 other identifier: 1935
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

The main objective of this study is to investigate the effect of resveratrol (plant derived food supplement) on inflammatory mediators and insulin resistance at the cellular and molecular level in obese non diabetic and type 2 diabetic subjects in vivo.

Conditions

Type 2 Diabetes; Obesity; Insulin Resistance

Keywords

Type 2 Diabetes; Obesity; Insulin Resistance; Resveratrol; Inflammation

Outcome Measures

Primary Outcomes (1)

• NF-Kb

  To investigate the effect of resveratrol on ROS generation and the pro-inflammatory transcription factor NF-kB

  12 weeks

Secondary Outcomes (1)

• GLP-1

  12 weeks

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Placebo tablets

Drug: Placebo

Resveratrol 40 mg oral three times a day

EXPERIMENTAL

Resveratrol

Drug: Resveratrol 40 mg oral three times a day

resveratrol 500 mg oral once daily.

EXPERIMENTAL

Resveratrol

Drug: Resveratrol 500 mg oral once daily.

Interventions

Placebo DRUG

oral

Placebo

Resveratrol 40 mg oral three times a day DRUG

Drug

Also known as: Resveratrol 40mg

Resveratrol 40 mg oral three times a day

Resveratrol 500 mg oral once daily. DRUG

Resveratrol 500 mg oral once daily.

Also known as: Resveratrol 500 mg

resveratrol 500 mg oral once daily.

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age and older
• Healthy Obese subjects with BMI \> 30
• Type 2 Diabetics with BMI \> 30
• Subjects with good peripheral vein.
• Subjects on statins, ACE inhibitors and thiazolidenediones will be allowed as long as they are on stable doses of these compounds and the dosage is not changed during the course of study.

You may not qualify if:

• Subjects on any antioxidant medication
• Patient on non-steroidal anti-inflammatory drug
• On any agent with significant antioxidant properties.
• History of drug or alcohol abuse
• Any life threatening disease
• Allergy to peanuts, grapes, wine, mulberries.
• Pregnant women.
• Coronary event or procedure (myocardial infarction, unstable angina, coronary artery bypass surgery or coronary angioplasty) in the previous four weeks.
• Subjects on anticoagulants.

Sponsors & Collaborators

• University at Buffalo: lead
• Kaleida Health: collaborator

Study Sites (1)

Jeanne Hejna

Williamsville, New York, 14221, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Obesity; Insulin Resistance; Inflammation

Interventions

Resveratrol

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hyperinsulinism; Pathologic Processes

Intervention Hierarchy (Ancestors)

Stilbestrols; Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polyphenols; Phenols

Study Officials

• Paresh Dandona, MD

  Kaleida Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: July 7, 2010
• First Posted: July 8, 2010
• Study Start: December 1, 2008
• Primary Completion: July 8, 2012
• Study Completion: July 8, 2012
• Last Updated: November 9, 2022

Record last verified: 2022-11

Locations

US (1)