Resveratrol in Metabolic Syndrome: Effect on Platelet Hyper-reactivity and HDL Lipid Peroxidation

NCT02219906 | Completed DMC

• 1 other identifier: 130996
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 2

Brief Summary

Metabolic syndrome is a group of risk factors that increase a patient's likelihood for heart attack, stroke and diabetes. Our research is aimed at understanding whether a drug, resveratrol, commonly found in grapes and red wine, would have any benefit in reducing risk factors in patients that have metabolic syndrome. Despite the use of aspirin and cholesterol reducing medications, patients with metabolic syndrome still often have sticky platelets and dysfunctional lipid profile. This is likely due to inflammation and high oxidative state. In animal studies, this drug has reduced platelet stickiness and reduced oxidative stress. However, the effects of this drug have not been researched in patients with metabolic syndrome. We are interested in studying whether the benefits of resveratrol described in animal models can be translated to patients with metabolic syndrome who display high markers of oxidative stress. We plan to give a short intervention of drug to patients and then determine if the drug successfully:

1. 1.Decreases the stickiness of platelets. This is important because sticky platelets are more likely to form clot and contribute to plaque formation.
2. 2.Reduce the circulating dysfunctional HDL. HDL and its protein and lipid constituents help to inhibit oxidation, inflammation, activation of the blood vessel wall, coagulation, and platelet aggregation. Dysfunctional HDL, as occurs in metabolic syndrome patients, cannot properly protect against atherosclerosis.

Conditions

Metabolic Syndrome

Outcome Measures

Primary Outcomes (4)

• Change in parameters of platelet activation

  Measure platelet-monocyte aggregates by flow cytometry

  baseline, 3 weeks after intervention

• Change in parameter for platelet oxidative stress

  Measure malondialdehyde adducts of platelet proteins

  Baseline, 3 weeks after intervention

• Change in parameter for platelet oxidation levels

  Measure superoxide production by platelets

  Baseline, 3 week after intervention

• Serum Thromboxane measurments

  Measure thromboxane to assess inflammation

  Baseline, 3 weeks after intervention

Secondary Outcomes (2)

• Change in oxidative modifications of HDL

  baseline, three weeks after intervention

• Change in plasma oxidative stress

  baselines, three weeks after intervention

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo capsule given three times daily X 3 weeks

Dietary Supplement: Placebo

Resveratrol

EXPERIMENTAL

Resveratrol 1 gram three times daily X 3 weeks

Dietary Supplement: Resveratrol

Interventions

Resveratrol DIETARY_SUPPLEMENT

1000mg tid

Also known as: tid dosing

Resveratrol

Placebo DIETARY_SUPPLEMENT

1000mg tid placebo

Also known as: tid dosing

Placebo

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Metabolic Syndrome

You may not qualify if:

• Evidence of coronary artery disease
• Indication for use of aspirin for secondary prevention of thrombotic events
• Use of non-steroidal anti-inflammatory drugs or anti-platelet agents
• Pregnancy
• Patients with history of bleeding or gastrointestinal ulcers
• Patients with major illnesses such as ongoing malignancies, infections, cirrhosis

Sponsors & Collaborators

• Vanderbilt University: lead

Study Sites (2)

Vanderbilt University

Nashville, Tennessee, 37232, United States

Location

Baylor University

Houston, Texas, 77004, United States

Location

MeSH Terms

Conditions

Metabolic Syndrome

Interventions

Resveratrol

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• John A Oates, MD

  Vanderbilt University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: August 14, 2014
• First Posted: August 19, 2014
• Study Start: May 1, 2014
• Primary Completion: February 7, 2019
• Study Completion: April 7, 2019
• Last Updated: April 19, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)