Clinical trial NCT01232608: Exercise Training in Patients With Coronary Heart Disease and Type 2 Diabetes
Official title: Exercise Training in Patients With Coronary Heart Disease and Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Diabetes Mellitus, Type 2
Atherosclerosis
Keywords: Coronary Artery Disease
Atherosclerosis.
Diabetes Mellitus, type 2
Exercise
HbA1c
Carotid Atherosclerotic Disease
Inflammation
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2010-11-02
Enrollment: 137
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* coronary artery disease
* type 2 diabetes

Exclusion Criteria:

* 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

Primary outcomes:
measure: Glucometabolic state
timeFrame: 12 months
measure: Atherosclerosis
timeFrame: 12 months
Secondary outcomes:
measure: Dyslipidemia
timeFrame: 12 months
measure: Visceral obesity
timeFrame: 12 months
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital, Ullevål
Study officials:
affiliation: Oslo University Hospital
name: Ingebjørg Seljeflot, phd professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Aune 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.
citation: Zaidi 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.