Viewing Study NCT01232608



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Study NCT ID: NCT01232608
Status: COMPLETED
Last Update Posted: 2013-04-05
First Post: 2010-10-25

Brief Title: Exercise Training in Patients With Coronary Heart Disease and Type 2 Diabetes
Sponsor: Oslo University Hospital
Organization: Oslo University Hospital

Study Overview

Official Title: Exercise Training in Patients With Coronary Heart Disease and Type 2 Diabetes
Status: COMPLETED
Status Verified Date: 2013-04
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: EXCADI
Brief Summary: Diabetes mellitus DM is an important risk factor in the development of cardiovascular disease and people with type 2 diabetes have a two- to four-fold increased risk for cardiovascular morbidity and mortality Physical activity is a well established therapeutic modality for type 2 diabetes In patients with coronary artery disease CAD several clinical trials have shown reduced mortality and reduced progression of atherosclerosis with lifestyle intervention including physical activity But few studies have investigated the effect of physical training in patients suffering from both diseases

The aim of this study is to investigate the effect of one year of organized physical exercise in patients with both coronary heart disease and type 2 diabetes on glucometabolic state and progression of atherosclerosis

The project is a randomized controlled open study on physical exercise 136 patients will be randomized at inclusion to a physical exercise group or a control group the latter with normal follow-up and not discouraged form physical activity The intervention period will be 12 months and the physical training program will be developed and conducted in collaboration with Norwegian School of Sport Sciences The inclusion of patients started summer 2010 the exercise program begins in September 2010 and the practical issues of the study is planned to end during spring 2012

The main hypothesis is that physical exercise improves the glucometabolic state and reduces progression of atherosclerosis in patients with coronary heart disease and type 2 diabetes and secondary that physical exercise induces favourable changes in cardiovascular risk factors use of medication and co-morbidity associated with diabetes
Detailed Description: None

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None