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

Not Applicable

Completed

• Conditions: Diabetes Type 2
• Interventions: Other: Exercise

• Registration Number: NCT01206725
• Lead Sponsor: Norwegian University of Science and Technology

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)

Study Timeline

• Study Start: 2010-09
• Study First Submitted: 2010-09-06
• Study First Submitted QC: 2010-09-21
• Study First Posted: 2010-09-22
• Primary Completion: 2012-11
• Study Completion: 2013-05
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-03
• Last Update Posted: 2018-01-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 47

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Aerobic interval training	Exercise	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.
. Moderate Intensity Exercise Group	Exercise	Exercise equivalent to the current exercise guidelines. In total 210 minutes per week of continuous moderate intensity (70% HRmax) exercise. Home based training.

Primary Outcome Measures

Name	Time	Method
Early diastolic tissue velocity (e')	3 months

Secondary Outcome Measures

Name	Time	Method
Early diastolic tissue velocity (e')	1 year

Trial Locations

Locations (1)

Institutt for sirkulasjon og bildediagnostikk, Det medisinske fakultet,NTNU, Postboks 8905; 🇳🇴 Trondheim, Sør-Trøndelag, Norway