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

NCT01206725 | Completed DMC

• 1 other identifier: 4.2009.365
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Type 2

Keywords

Diabetes type 2; exercise; tissue Doppler velocity

Outcome Measures

Primary Outcomes (1)

• Early diastolic tissue velocity (e')

  3 months

Secondary Outcomes (1)

• Early diastolic tissue velocity (e')

  1 year

Study Arms (2)

. Moderate Intensity Exercise Group

OTHER

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

Aerobic interval training

OTHER

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

Interventions

Exercise OTHER

1. 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. 2. 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.

. Moderate Intensity Exercise Group; Aerobic interval training

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Norwegian University of Science and Technology: lead

Study Sites (1)

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

Trondheim, Sør-Trøndelag, 7491, Norway

Location

Related Publications (4)

• 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.

  PMID: 25323267 RESULT

• 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.

  PMID: 28392340 RESULT

• 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.

  PMID: 26948543 RESULT

• 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.

  PMID: 32693740 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Charlotte B Ingul, PhD

  NTNU, Det medisinske fakultet, Institutt for sirkulasjon og bildediagnostikk

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2010
• First Posted: September 22, 2010
• Study Start: September 1, 2010
• Primary Completion: November 1, 2012
• Study Completion: May 1, 2013
• Last Updated: January 5, 2018

Record last verified: 2018-01

Locations

NO (1)