The CardioDiet Trial
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Ischemic Heart Disease
- Sponsor
- University Hospital, Linkoeping
- Enrollment
- 1200
- Locations
- 1
- Primary Endpoint
- Diabetes incidence
- Last Updated
- 7 years ago
Overview
Brief Summary
This is a multi-centre, open, randomised study in patients treated for ischemic heart disease in Linköping, Norrköping and Jönköping hospitals. One thousand two hundred patients who are treated at the cardiac rehabilitation units will be consecutively recruited during three years. The patients will be randomised 1:1 to be given advice on a 1) Mediterranean diet with an energy content (E%) from carbohydrates between 25-30% or to 2) a traditional low-fat diet with 45-60 E% from carbohydrates. All eligible patients will be asked if they want to participate and provided with written information about the study when they are discharged from the hospital after treatment for ischemic heart disease. The decision to participate or not will be given at the following outpatient treatment at the cardiac rehabilitation unit. When the signed informed consent to participate in the study has been provided, the patient will be randomised to advice of either of the two dietary regimes.
Detailed Description
Aim To compare advice on a Mediterranean diet with an energy content (E%) from carbohydrates between 25-30 E% with a traditional low-fat diet with 45-60 E% from carbohydrates. Primary outcome Incidence of diabetes in non-diabetic patients or glycaemic control in patients with known diabetes. Secondary outcome Recurrence of cardiovascular disease, blood lipid levels, quality of life by questionnaires. Study design and study population This is a multi-centre, open, randomised study in patients treated for ischemic heart disease in Linköping, Norrköping and Jönköping hospitals. One thousand two hundred patients who are treated at the cardiac rehabilitation units will be consecutively recruited during three years. The patients will be randomised 1:1 to be given advice on a 1) Mediterranean diet with an energy content (E%) from carbohydrates between 25-30% or to 2) a traditional low-fat diet with 45-60 E% from carbohydrates. All eligible patients will be asked if they want to participate and provided with written information about the study when they are discharged from the hospital after treatment for ischemic heart disease. The decision to participate or not will be given at the following outpatient treatment at the cardiac rehabilitation unit. When the signed informed consent to participate in the study has been provided, the patient will be randomised to advice of either of the two dietary regimes.
Investigators
Fredrik H Nystrom
Professor, MD
University Hospital, Linkoeping
Eligibility Criteria
Inclusion Criteria
- •Patients treated for ischemic heart disease who are followed up at the cardiac rehabilitation units
Exclusion Criteria
- •Inability to affect food choice. Severe concomitant disease such as malignancy, renal failure, heart failure or psychiatric disease.
Outcomes
Primary Outcomes
Diabetes incidence
Time Frame: 3 years
Hba1c \> 48 mmol/mol
Secondary Outcomes
- Cardiovascular disease(3 years and more)
- Quality of Life(3 years)