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Polyphenol
Resveratrol for Coronary Artery Disease (SIRT-CVS Trial)
N/A
Waitlist Available
Led By Michael Robich, MD
Research Sponsored by MaineHealth
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 14 days
Summary
This trial will test whether resveratrol can help reverse the negative effects of diabetes on the heart.
Who is the study for?
Adults over 18 with Type 2 diabetes and coronary artery disease scheduled for elective heart bypass surgery can join. They must not have severe kidney, liver, or blood clotting issues, be pregnant, or have certain infections like HIV. Heavy drinkers and those unlikely to follow the study plan are excluded.
What is being tested?
The trial is testing if resveratrol (found in grapes/red wine) can improve heart health in diabetics by comparing it against a placebo. It looks at how it affects heart metabolism, inflammation, blood vessel function, and cardiac repair cells.
What are the potential side effects?
While specific side effects aren't listed here, resveratrol could potentially cause digestive upset or allergic reactions in some people. The trial will monitor participants closely for any adverse effects.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 14 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~14 days
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in endothelial function
Secondary study objectives
Effects of resveratrol on caveolar function
Effects of resveratrol on molecular signaling
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: ResveratrolExperimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Trans-resveratrol
2012
Completed Phase 1
~80
Find a Location
Who is running the clinical trial?
MaineHealthLead Sponsor
74 Previous Clinical Trials
43,865 Total Patients Enrolled
American Heart AssociationOTHER
346 Previous Clinical Trials
4,971,452 Total Patients Enrolled
4 Trials studying Diabetes
491 Patients Enrolled for Diabetes
Michael Robich, MDPrincipal InvestigatorMaine Medical Center / MaineHealth
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your blood clotting tests show abnormal results.Your liver function tests show results more than two times the normal range.You have tested positive for HIV, Hepatitis B, or Hepatitis C.You are over 18 years old.You have any type of cancer except non-melanoma skin cancers.You are allergic to the ingredients in the supplement or the placebo.You have severe heart failure or weak heart function.You have serious heart rhythm problems.You have type 2 diabetes that is managed with pills or insulin.Your kidneys are not working well (your GFR is less than 60 mL/min).Your blood pressure is very low (less than 90 mmHg) when you join the study.You are not expected to live for more than one year.You drink more than 2.5 glasses of wine every day.You have coronary artery disease and are scheduled for elective coronary artery bypass grafting with cardiopulmonary bypass.
Research Study Groups:
This trial has the following groups:- Group 1: Resveratrol
- Group 2: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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