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NCT Number: NCT01206725

Exercise Study on Cardiac Function in Patients With Diabetes Mellitus Type 2 and Diastolic Dysfunction

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.

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Key information

Conditions

Diabetes Type 2 Behavior Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Motor Activity Nutritional and Metabolic Diseases

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institutt for sirkulasjon og bildediagnostikk, Det medisinske fakultet,NTNU, Postboks 8905

Trondheim, Sør-Trøndelag, 7491, Norway

About this study

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)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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
  • LVH
  • Retinopathy
  • Neuropathy
  • Micro or macroalbuminuria
  • EF < 40%
  • BMI >35
  • Ischemia at exercise echocardiography
  • Disease or disability making training difficult.

Treatment and study plan

Exercise

Other
  • Moderate Intensity Exercise Group (ME). Exercise equivalent to the current exercise guidelines. In total 210 minutes per week of continuous moderate intensity (70% HRmax) exercise. Home based training.
  • Aerobic interval training (AIT). Exercise equivalent to the current guidelines achieved through high-intensity interval training.The exercise starts with warming-up for 10-min at 70% of HRmax before performing 4x4min intervals at 90-95% of HRmax, with 3-min active recovery at 70% of HRmax between each interval, and a 5-min cool-down period, giving a total of 40-min.

Primary outcomes

  1. Early diastolic tissue velocity (e')

    Time frame: 3 months

Secondary outcomes

  1. Early diastolic tissue velocity (e')

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Norwegian University of Science and Technology

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2012
Study completion
2013
First posted
Sep 22, 2010
Registry last updated
Jan 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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