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

Primary Purpose

Diabetes Type 2

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Exercise
Sponsored by
Norwegian University of Science and Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Type 2 focused on measuring Diabetes type 2, exercise, tissue Doppler velocity

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

. Moderate Intensity Exercise Group

Aerobic interval training

Arm Description

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

Outcomes

Primary Outcome Measures

Early diastolic tissue velocity (e')

Secondary Outcome Measures

Early diastolic tissue velocity (e')

Full Information

First Posted
September 6, 2010
Last Updated
January 3, 2018
Sponsor
Norwegian University of Science and Technology
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1. Study Identification

Unique Protocol Identification Number
NCT01206725
Brief Title
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

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
September 2010 (Actual)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Norwegian University of Science and Technology

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Type 2
Keywords
Diabetes type 2, exercise, tissue Doppler velocity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
47 (Actual)

8. Arms, Groups, and Interventions

Arm Title
. Moderate Intensity Exercise Group
Arm Type
Other
Arm Description
Exercise equivalent to the current exercise guidelines. In total 210 minutes per week of continuous moderate intensity (70% HRmax) exercise. Home based training.
Arm Title
Aerobic interval training
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Exercise
Intervention Description
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 Outcome Measure Information:
Title
Early diastolic tissue velocity (e')
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Early diastolic tissue velocity (e')
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charlotte B Ingul, PhD
Organizational Affiliation
NTNU, Det medisinske fakultet, Institutt for sirkulasjon og bildediagnostikk
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institutt for sirkulasjon og bildediagnostikk, Det medisinske fakultet,NTNU, Postboks 8905
City
Trondheim
State/Province
Sør-Trøndelag
ZIP/Postal Code
7491
Country
Norway

12. IPD Sharing Statement

Citations:
PubMed Identifier
25323267
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.
Results Reference
result
PubMed Identifier
28392340
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.
Results Reference
result
PubMed Identifier
26948543
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.
Results Reference
result
PubMed Identifier
32693740
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.
Results Reference
derived

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

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