Exercise Training in Patients With Coronary Heart Disease and Type 2 Diabetes
EXCADI
1 other identifier
interventional
137
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable coronary-artery-disease
Started Jun 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2010
CompletedFirst Submitted
Initial submission to the registry
October 25, 2010
CompletedFirst Posted
Study publicly available on registry
November 2, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2013
CompletedApril 5, 2013
April 1, 2013
2.8 years
October 25, 2010
April 4, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Glucometabolic state
Glucometabolic state is defined as: HbA1c, fasting insulin, fasting c-peptid, fasting blood glucose
12 months
Atherosclerosis
Atherosclerosis will be assessed by measurements of: * Carotid intima-media thickness (IMT) * Biomarkers of inflammation, haemostasis and endothelial function
12 months
Secondary Outcomes (2)
Dyslipidemia
12 months
Visceral obesity
12 months
Study Arms (2)
Exercise
EXPERIMENTAL12 months of exercise training
Control
NO INTERVENTIONNormal follow-up by primary physician
Interventions
Eligibility Criteria
You may qualify if:
- coronary artery disease
- type 2 diabetes
You may not qualify if:
- serious diabetic retinopathy, nephropathy and/ or neuropathy
- other serious diseases like cancer, stroke or MI last three months, unstable angina, decompensated heart failure, serious ventricular arrhythmia, aortic aneurism, serious valvular heart disease, chronic obstructive pulmonary disease GOLD classification IV, deep venous/ pulmonary embolism, ongoing infections, serious musculoskeletal disorders.
- other serious limitations to physical exercise
- pathological exercise stress test warranting further cardiovascular examination
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Oslo University Hospital, Ullevål
Oslo, NO-0424, Norway
Related Publications (3)
Zaidi H, Byrkjeland R, Njerve IU, Akra S, Solheim S, Arnesen H, Seljeflot I, Opstad TB. Adiponectin in relation to exercise and physical performance in patients with type 2 diabetes and coronary artery disease. Adipocyte. 2021 Dec;10(1):612-620. doi: 10.1080/21623945.2021.1996699.
PMID: 34779349DERIVEDAune SK, Byrkjeland R, Solheim S, Arnesen H, Troseid M, Awoyemi A, Seljeflot I, Helseth R. Gut related inflammation and cardiorespiratory fitness in patients with CAD and type 2 diabetes: a sub-study of a randomized controlled trial on exercise training. Diabetol Metab Syndr. 2021 Apr 1;13(1):36. doi: 10.1186/s13098-021-00655-2.
PMID: 33794977DERIVEDZaidi H, Byrkjeland R, Njerve IU, Akra S, Solheim S, Arnesen H, Seljeflot I, Opstad TB. Effects of exercise training on markers of adipose tissue remodeling in patients with coronary artery disease and type 2 diabetes mellitus: sub study of the randomized controlled EXCADI trial. Diabetol Metab Syndr. 2019 Dec 19;11:109. doi: 10.1186/s13098-019-0508-9. eCollection 2019.
PMID: 31890043DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ingebjørg Seljeflot, phd professor
Oslo University Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 25, 2010
First Posted
November 2, 2010
Study Start
June 1, 2010
Primary Completion
March 1, 2013
Study Completion
March 1, 2013
Last Updated
April 5, 2013
Record last verified: 2013-04