Clinical trial NCT01206725: Exercise Study on Cardiac Function in Patients With Diabetes Mellitus Type 2 and Diastolic Dysfunction
Official title: The Effect of Aerobic Interval Training on Cardiac Function in Patients With Diabetes Mellitus Type 2 and Diastolic Dysfunction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Type 2
Keywords: Diabetes type 2
exercise
tissue Doppler velocity
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
First posted: 2010-09-22
Enrollment: 47
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)

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

Primary outcomes:
measure: Early diastolic tissue velocity (e')
timeFrame: 3 months
Secondary outcomes:
measure: Early diastolic tissue velocity (e')
timeFrame: 1 year
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: Institutt for sirkulasjon og bildediagnostikk, Det medisinske fakultet,NTNU, Postboks 8905
state: Sør-Trøndelag
Study officials:
affiliation: NTNU, Det medisinske fakultet, Institutt for sirkulasjon og bildediagnostikk
name: Charlotte B Ingul, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hollekim-Strand SM, Bjorgaas MR, Albrektsen G, Tjonna AE, Wisloff U, Ingul CB. High-intensity interval exercise effectively improves cardiac function in patients with type 2 diabetes mellitus and diastolic dysfunction: a randomized controlled trial. J Am Coll Cardiol. 2014 Oct 21;64(16):1758-60. doi: 10.1016/j.jacc.2014.07.971. No abstract available.
citation: Mallard AR, Hollekim-Strand SM, Coombes JS, Ingul CB. Exercise intensity, redox homeostasis and inflammation in type 2 diabetes mellitus. J Sci Med Sport. 2017 Oct;20(10):893-898. doi: 10.1016/j.jsams.2017.03.014. Epub 2017 Mar 21.
citation: Hollekim-Strand SM, Hoydahl SF, Follestad T, Dalen H, Bjorgaas MR, Wisloff U, Ingul CB. Exercise Training Normalizes Timing of Left Ventricular Untwist Rate, but Not Peak Untwist Rate, in Individuals with Type 2 Diabetes and Diastolic Dysfunction: A Pilot Study. J Am Soc Echocardiogr. 2016 May;29(5):421-430.e2. doi: 10.1016/j.echo.2016.01.005. Epub 2016 Mar 3.
citation: Mallard AR, Hollekim-Strand SM, Ingul CB, Coombes JS. High day-to-day and diurnal variability of oxidative stress and inflammation biomarkers in people with type 2 diabetes mellitus and healthy individuals. Redox Rep. 2020 Dec;25(1):64-69. doi: 10.1080/13510002.2020.1795587.