Status:
ACTIVE_NOT_RECRUITING
Short Interval Resveratrol Trial in Cardiovascular Surgery
Lead Sponsor:
MaineHealth
Collaborating Sponsors:
American Heart Association
Conditions:
Diabetes Mellitus, Type 2
Coronary Artery Disease
Eligibility:
All Genders
18+ years
Phase:
NA
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 a...
Detailed Description
Patients with diabetes and metabolic diseases such as obesity, hypertension and dyslipidemia have a myocardial environment that results in endothelial dysfunction, altered metabolism and little potent...
Eligibility Criteria
Inclusion
- Adult patients (age \>18 years)
- Type 2 diabetes (controlled by either oral agents or insulin)
- Coronary artery disease referred for elective CABG with CPB
Exclusion
- 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.
Key Trial Info
Start Date :
March 6 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT03762096
Start Date
March 6 2018
End Date
December 31 2026
Last Update
April 3 2025
Active Locations (1)
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1
Maine Medical Center
Portland, Maine, United States, 04102