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Clinical Trials/NCT01206725
NCT01206725
Completed
Not Applicable

The Effect of Aerobic Interval Training on Cardiac Function in Patients With Diabetes Mellitus Type 2 and Diastolic Dysfunction

Norwegian University of Science and Technology1 site in 1 country47 target enrollmentSeptember 2010
ConditionsDiabetes Type 2

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Diabetes Type 2
Sponsor
Norwegian University of Science and Technology
Enrollment
47
Locations
1
Primary Endpoint
Early diastolic tissue velocity (e')
Status
Completed
Last Updated
8 years ago

Overview

Brief Summary

The aim of the study is to compare the effects of aerobic interval training and the IDF recommendations on physical activity on cardiac function and CV risk factors in patients with diabetes. The hypothesis is that AIT more than MCT, will improve myocardial dysfunction in patients with subclinical LV disease, improve both endothelial function and VO2max and thus reducing CV risk factors and CV disease. HbA1c will be more stable.

The aims of this study are to address the exercise prescription recommendations for patients with (T2DM) who have subclinical heart disease. The prescription recommendations will be assessed by randomising T2DM patients with subclinical heart disease to one of the following 2 groups for 3 months followed by a 9 month home-based program:

Moderate Intensity Exercise Group (ME). Home exercise equivalent to the present exercise recommendations of the International Diabetes Federation.

Aerobic interval training (AIT). Exercise equivalent to the current guidelines achieved through high-intensity interval training.

Detailed Description

The investigators primary hypotheses are that in patients with type 2 diabetes and subclinical heart disease: Moderate Intensity Exercise will: Not significantly improve myocardial function compared to controls, Despite significant improvement (compared to controls) in: Glycaemic control (HbA1c) Cardiorespiratory fitness (VO2max) Body composition (DXA) Aerobic Interval Training Group will: Significantly improve myocardial function compared to controls, Significantly improve (compared to moderate intensity exercise group): Glycaemic control (HbA1c) Cardiorespiratory fitness (VO2max) Body composition (DXA)

Registry
clinicaltrials.gov
Start Date
September 2010
End Date
May 2013
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Patients 20-60 years with diagnose diabetes mellitus type 2 (without insulin) for less than 10 years and with diastolic dysfunction (E'\<8), will be included.

Exclusion Criteria

  • Overt CV disease
  • History of CAD
  • Moderate to severe valvular disease (AI MI 3-4, AS peak gradient \> 15 mmHg=2m/s)
  • Atrial fibrillation or other severe arrhythmia
  • Congenital heart disease
  • Untreated hypertension \>140/90
  • Retinopathy
  • Neuropathy
  • Micro or macroalbuminuria
  • EF \< 40%

Outcomes

Primary Outcomes

Early diastolic tissue velocity (e')

Time Frame: 3 months

Secondary Outcomes

  • Early diastolic tissue velocity (e')(1 year)

Study Sites (1)

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