Status:
TERMINATED
Effects of Mediterranean Diet Intervention in Diabetic Heart Disease
Lead Sponsor:
MaineHealth
Conditions:
Diabetes Complications
Cardiovascular Diseases
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Diabetes Mellitus (DM) is a global epidemic associated with inflammation, aggressive atherosclerosis and increased risk for, and severity of, coronary artery disease. Strategies to improve glycemic co...
Detailed Description
Study Design: The study is a prospective, un-blinded, randomized interventional clinical trial comparing ModMeD to standard cardiac diet in 48 (24 per arm) inpatients with type II DM scheduled for CAB...
Eligibility Criteria
Inclusion
- Over 18 years of age
- A diagnosis of TIIDM (defined as current treatment with insulin or oral hypoglycemic medication or fasting glucose \>126 mg/dl)
- Hemoglobin A1c level greater than 7.5%
- Planned coronary artery bypass grafting (CABG) (primary only)
- Planned pre-surgical hospital stay
- Willingness to adhere to Mediterranean diet while an inpatient at MMC
Exclusion
- Less than 18 years of age
- Unwillingness or inability to provide informed consent
- Planned surgery within 48 hours
- Active myocarditis
- Hypertrophic cardiomyopathy
- Constrictive pericarditis
- Prior or current pericardial disease requiring surgical intervention
- Significant renal impairment (Cr \> 2.5 mg/dL)
- Food allergies towards tree nuts or other food items included on the Mediterranean menu
- Pregnancy
- Expected survival less than one year
- Non-English speaker
Key Trial Info
Start Date :
December 15 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 24 2023
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT03757845
Start Date
December 15 2018
End Date
March 24 2023
Last Update
March 28 2023
Active Locations (1)
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1
Maine Medical Center
Portland, Maine, United States, 04102