Exercise Study on Cardiac Function in Patients With Diabetes Mellitus Type 2 and Diastolic Dysfunction - Full Text View

Purpose

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.

Condition	Intervention
Diabetes Type 2	Other: Exercise

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	The Effect of Aerobic Interval Training on Cardiac Function in Patients With Diabetes Mellitus Type 2 and Diastolic Dysfunction

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Diabetes Type 2 Exercise and Physical Fitness

U.S. FDA Resources

Further study details as provided by Norwegian University of Science and Technology:

Primary Outcome Measures:

Early diastolic tissue velocity (e') [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Early diastolic tissue velocity (e') [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment:	90
Study Start Date:	September 2010
Estimated Study Completion Date:	May 2013
Primary Completion Date:	November 2012 (Final data collection date for primary outcome measure)

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

Arms

Assigned Interventions

. Moderate Intensity Exercise Group

Exercise equivalent to the current exercise guidelines. In total 210 minutes per week of continuous moderate intensity (70% HRmax) exercise. Home based training.

Other: Exercise

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.

Aerobic interval training

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.

Other: Exercise

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.

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)

Eligibility

Ages Eligible for Study:	20 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01206725

Locations

Norway
Institutt for sirkulasjon og bildediagnostikk, Det medisinske fakultet,NTNU, Postboks 8905
Trondheim, Sør-Trøndelag, Norway, 7491

Sponsors and Collaborators

Norwegian University of Science and Technology

Investigators

Principal Investigator:

Charlotte B Ingul, PhD

NTNU, Det medisinske fakultet, Institutt for sirkulasjon og bildediagnostikk

More Information

No publications provided

Responsible Party:	Norwegian University of Science and Technology
ClinicalTrials.gov Identifier:	NCT01206725 History of Changes
Other Study ID Numbers:	4.2009.365
Study First Received:	September 6, 2010
Last Updated:	April 10, 2013
Health Authority:	Norway: Ethics Committee

Keywords provided by Norwegian University of Science and Technology:

Diabetes type 2
exercise
tissue Doppler velocity

Additional relevant MeSH terms:

Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 23, 2013