Short Interval Resveratrol Trial in Cardiovascular Surgery

NCT03762096 | Active Not Recruiting DMC

• 1 other identifier: 1095584
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Major Problem People with diabetes have an increased risk of heart disease, heart failure, and death from a cardiovascular cause. Diabetes prevents efficient metabolism of fuel, causes inflammation and vascular disease that blocks normal blood flow, and inhibits the function of the heart after injury. These changes make diabetics more susceptible to heart attacks and heart failure. Resveratrol is found in grapes and red wine and has been shown to have beneficial effects in diabetic patients. In previous studies the investigators have shown that resveratrol can improve heart metabolism and function in pigs with diabetes and chronic lack of blood flow to the heart. Questions The investigators believe resveratrol will help reverse the negative effects of diabetes on the heart. The questions are: 1.How does the molecular machinery in the hearts of patients with diabetes differ from patients without diabetes? 2.Will resveratrol have an effect on heart metabolism, intracellular signaling, inflammation and blood vessel function? 3.Will resveratrol improve the number and function of cardiac stem cells, cells involved in heart repair? The investigators have been safely collecting tissue from the hearts of patients undergoing heart surgery. Preliminary studies show the investigators can isolate and study cells. The investigators have collected and assessed the function of endothelial cells, a measure of vascular health and can measure the level of endothelial injury and have studied the make-up of caveolae, structures on the cell membrane that are important for cell signaling and are negatively impacted by diabetes. This study is a unique collaboration among cardiologists, cardiac surgeons, and basic scientists.

Conditions

Diabetes Mellitus, Type 2; Coronary Artery Disease

Outcome Measures

Primary Outcomes (2)

• Change in endothelial function

  Serum levels of nitric oxide (ELISA assay)

  6 weeks

• Change in endothelial function

  Nitric oxide synthase levels in heart tissue (Western blot assay)

  14 days

Secondary Outcomes (2)

• Effects of resveratrol on caveolar function

  14 days

• Effects of resveratrol on molecular signaling

  14 days

Study Arms (2)

Resveratrol

EXPERIMENTAL

Dietary Supplement: Trans-resveratrol

Placebo

PLACEBO COMPARATOR

Dietary Supplement: Placebo

Interventions

Trans-resveratrol DIETARY_SUPPLEMENT

1 gram, twice a day by mouth Transmax (Biotivia)

Also known as: resveratrol

Resveratrol

Placebo DIETARY_SUPPLEMENT

Placebo

Placebo

Eligibility Criteria

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

You may qualify if:

• Adult patients (age \>18 years)
• Type 2 diabetes (controlled by either oral agents or insulin)
• Coronary artery disease referred for elective CABG with CPB

You may not qualify if:

• Known decompensated congestive heart failure or systolic heart failure with an ejection fraction \< 45% at the time of evaluation
• Liver Function Tests (LFT) greater than 2 times normal
• Renal dysfunction (GFR less than 60 mL/min)
• Abnormal coagulation profile (PT/PTT and INR)
• Alcohol consumption more than 3 grams (equivalent to 2.5 glasses of wine) daily
• Positive HIV, Hepatitis B or C testing
• Severe ventricular arrhythmias
• Significant hypotension (SBP \< 90 mmHg) at the time of enrollment
• Patients who are pregnant
• Known malignancy other than non-melanoma skin cancers
• Expected survival less than one year.
• Allergy or intolerance to the ingredients of the supplement or the placebo
• Inability to comply with the study requirements.

Sponsors & Collaborators

• MaineHealth: lead
• American Heart Association: collaborator

Study Sites (1)

Maine Medical Center

Portland, Maine, 04102, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Coronary Artery Disease

Interventions

Resveratrol

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• Douglas Sawyer

  Maine Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Academic Officer

Study Record Dates

• First Submitted: November 30, 2018
• First Posted: December 3, 2018
• Study Start: March 6, 2018
• Primary Completion: April 16, 2021
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 3, 2025

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)