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Clinical Trials/NCT02938832
NCT02938832
Unknown
Phase 4

The CardioDiet Trial

University Hospital, Linkoeping1 site in 1 country1,200 target enrollmentOctober 2016

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.

Registry
clinicaltrials.gov
Start Date
October 2016
End Date
October 2023
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
University Hospital, Linkoeping
Responsible Party
Principal Investigator
Principal Investigator

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)

Study Sites (1)

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