NCT03762096Active, not recruiting
Short Interval Resveratrol Trial in Cardiovascular Surgery
Source: ClinicalTrials.gov · Last updated 3 Apr 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- First submitted
- 30 Nov 2018
- Start date
- Mar 2018
- Primary completion date
- Apr 2021
- Lead sponsor
- MaineHealth
- Diseases
- Coronary artery disease, Type 2 diabetes
- NCT number
- NCT03762096
What you commit to
- Study type: Interventional
- Planned participants: 40
- From Mar 2018 to the primary completion date, Apr 2021
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Positive HIV, Hepatitis B or C testing
- Severe ventricular arrhythmias
- Known malignancy other than non-melanoma skin cancers
- Allergy or intolerance to the ingredients of the supplement or the placebo
Lab values
- Known decompensated congestive heart failure or systolic heart failure with an ejection fraction \< 45% at the time of evaluation
- Renal dysfunction (GFR less than 60 mL/min)
- Abnormal coagulation profile (PT/PTT and INR)
Other
- Liver Function Tests (LFT) greater than 2 times normal
- Alcohol consumption more than 3 grams (equivalent to 2.5 glasses of wine) daily
- Significant hypotension (SBP \< 90 mmHg) at the time of enrollment
- Patients who are pregnant
- Expected survival less than one year.
- Inability to comply with the study requirements.
Who the study is looking for
- Adult patients (age \>18 years)
- Type 2 diabetes (controlled by either oral agents or insulin)
- Coronary artery disease referred for elective CABG with CPB
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Maine Medical Center Coordinator of this site? Confirm its status | Portland | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.