NCT03299790

Brief Summary

According to data of the International Diabetes Federation (IDF), diabetes in general affects approximately 415 million people worldwide and this number is still increasing. Cardiovascular diseases, one of the major complications of diabetes, are the leading cause of mortality and morbidity in the diabetic population. One of the cardiovascular complications is diabetic cardiomyopathy, in which structural and functional changes occur in the heart impairing cardiac function. Exercise training has already proven the benefits on glycemic control in diabetes. This is also the case for the effects on cardiac function. However, as results are conflicting, it remains unclear which elements of exercise training should be focused on. For instance, high-intensity interval training (HIIT) is gaining interest as positive effects are already shown on glycemic control. Therefore, the potential of HIIT to improve cardiac function in diabetes should be investigated. Further on, the effects of exercise training on cardiac function are mainly investigated during rest by the use of transthoracic echocardiography. Therefore, as data are lacking, it remains unclear how the diabetic heart functions during exercise. The aim of the present study is to investigate the effects of different training modalities (e.g. HIIT) on heart function in diabetes both during rest and during exercise itself. Therefore, cardiac function will be evaluated by the use transthoracic (exercise) echocardiography. This will be combined by the evaluation of several biochemical parameters. The results will provide more insight in the pathology of diabetic cardiomyopathy as well as the potential of exercise training for this cardiovascular complication. Eventually, this research will contribute to the optimization of exercise programs for patients with diabetes.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
53

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 12, 2017

Completed
21 days until next milestone

First Posted

Study publicly available on registry

October 3, 2017

Completed
3 days until next milestone

Study Start

First participant enrolled

October 6, 2017

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2020

Completed
Last Updated

December 10, 2020

Status Verified

December 1, 2020

Enrollment Period

2.2 years

First QC Date

September 12, 2017

Last Update Submit

December 9, 2020

Conditions

Diabetic CardiomyopathiesType2 Diabetes

Keywords

Type 2 diabetesDiabetic cardiomyopathyCardiac functionExercise echocardiographyExercise training

Outcome Measures

Primary Outcomes (12)

  • Transthoracic echocardiography (TTE) during excercise

    heart function during exercise by means of standard echocardiography: evaluation of diastolic and systolic function (mitral inflow pattern, ejection fraction, tissue doppler imaging, strain rate analyses,…) and cardiac structure (left ventricle mass, intraventricular wall mass,…)

    day 1

  • Transthoracic echocardiography (TTE) during excercise

    heart function during exercise by means of standard echocardiography: evaluation of diastolic and systolic function (mitral inflow pattern, ejection fraction, tissue doppler imaging, strain rate analyses,…) and cardiac structure (left ventricle mass, intraventricular wall mass,…)

    month 3

  • Transthoracic echocardiography (TTE) during excercise

    heart function during exercise by means of standard echocardiography: evaluation of diastolic and systolic function (mitral inflow pattern, ejection fraction, tissue doppler imaging, strain rate analyses,…) and cardiac structure (left ventricle mass, intraventricular wall mass,…)

    month 6

  • Transthoracic echocardiography (TTE) during excercise

    heart function during exercise by means of standard echocardiography: evaluation of diastolic and systolic function (mitral inflow pattern, ejection fraction, tissue doppler imaging, strain rate analyses,…) and cardiac structure (left ventricle mass, intraventricular wall mass,…)

    month 12

  • Transthoracic echocardiography (TTE)

    heart function in rest by means of standard echocardiography: evaluation of diastolic and systolic function (mitral inflow pattern, ejection fraction, tissue doppler imaging, strain rate analyses,…) and cardiac structure (left ventricle mass, intraventricular wall mass,…)

    day 1

  • Transthoracic echocardiography (TTE)

    heart function in rest by means of standard echocardiography: evaluation of diastolic and systolic function (mitral inflow pattern, ejection fraction, tissue doppler imaging, strain rate analyses,…) and cardiac structure (left ventricle mass, intraventricular wall mass,…)

    month 3

  • Transthoracic echocardiography (TTE)

    heart function in rest by means of standard echocardiography: evaluation of diastolic and systolic function (mitral inflow pattern, ejection fraction, tissue doppler imaging, strain rate analyses,…) and cardiac structure (left ventricle mass, intraventricular wall mass,…)

    month 6

  • Transthoracic echocardiography (TTE)

    heart function in rest by means of standard echocardiography: evaluation of diastolic and systolic function (mitral inflow pattern, ejection fraction, tissue doppler imaging, strain rate analyses,…) and cardiac structure (left ventricle mass, intraventricular wall mass,…)

    month 12

  • ECG (Electrocardiogram) during excercise

    ECG during excercise (an incremental exercise test on a cycle)

    month 3

  • ECG (Electrocardiogram) during excercise

    ECG during excercise (an incremental exercise test on a cycle)

    month 12

  • ECG (Electrocardiogram)

    ECG in rest

    month 3

  • ECG (Electrocardiogram)

    ECG in rest

    month 12

Secondary Outcomes (22)

  • Glycemic control

    day 1

  • Glycemic control

    month 3

  • Glycemic control

    month 6

  • Glycemic control

    month 12

  • Insulin metabolism

    day 1

  • +17 more secondary outcomes

Study Arms (4)

training group 1: HIIT

ACTIVE COMPARATOR

high-intensity interval exercise training group (T2DM patients)

Other: high-intensity interval exercise training (HIIT)

training group 2: MIT

ACTIVE COMPARATOR

moderate-intensity exercise training group (T2DM patients)

Other: moderate-intensity exercise training (MIT)

Detraining period

NO INTERVENTION

Follow-up: detraining of group 1 and 2 (T2DM patients)

Healthy controls

NO INTERVENTION

Interventions

high-intensity interval exercise training (HIIT)OTHER

This program includes 24 weeks of exercise training and is divided in different phases (phase 1: week 1-2, equal to the MIT group, phase 2: week 3-6, 6 bouts of high-intensity exercise, phase 3: week 7-12, 7 bouts of high-intensity exercise, phase 4: week 13-24, 8 bouts of high-intensity exercise). The exercise training program consists of 3 exercise sessions per week (for 6 months).

training group 1: HIIT
moderate-intensity exercise training (MIT)OTHER

This program includes 24 weeks of exercise training and is not devided in phases. The exercise training program consists of 3 endurance exercise sessions per week (for 6 months). The total exercise volume equals the exercise volume of the HIIT group.

training group 2: MIT

Eligibility Criteria

Age18 Years - 81 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • type 2 diabetes patients:
  • BMI \> 20kg/m²
  • diagnosis of T2DM as stated in guidelines of ADA (American Diabetes Association)
  • stable medication for at least 3 months
  • Healthy controls:
  • BMI \> 20kg/m²
  • no diabetes

You may not qualify if:

  • iron deficiency anemia
  • participation in another clinical trial
  • heart diseases: CAD (coronary artery disease), ischemia, valvular diseases, congenital heart diseases
  • neurological, pneumological, oncological, orthopedic disorders
  • diabetes complications: renal diseases, retinopathy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jessa Ziekenhuis

Hasselt, 3500, Belgium

Location

Related Publications (3)

  • Van Ryckeghem L, Keytsman C, De Brandt J, Verboven K, Verbaanderd E, Marinus N, Franssen WMA, Frederix I, Bakelants E, Petit T, Jogani S, Stroobants S, Dendale P, Bito V, Verwerft J, Hansen D. Impact of continuous vs. interval training on oxygen extraction and cardiac function during exercise in type 2 diabetes mellitus. Eur J Appl Physiol. 2022 Apr;122(4):875-887. doi: 10.1007/s00421-022-04884-9. Epub 2022 Jan 17.

    PMID: 35038022DERIVED

  • Van Ryckeghem L, Keytsman C, Verboven K, Verbaanderd E, Frederix I, Bakelants E, Petit T, Jogani S, Stroobants S, Dendale P, Bito V, Verwerft J, Hansen D. Exercise capacity is related to attenuated responses in oxygen extraction and left ventricular longitudinal strain in asymptomatic type 2 diabetes patients. Eur J Prev Cardiol. 2022 Jan 11;28(16):1756-1766. doi: 10.1093/eurjpc/zwaa007.

    PMID: 33623980DERIVED

  • Van Ryckeghem L, Keytsman C, Verbaanderd E, Frederix I, Bakelants E, Petit T, Jogani S, Stroobants S, Dendale P, Bito V, Verwerft J, Hansen D. Asymptomatic type 2 diabetes mellitus display a reduced myocardial deformation but adequate response during exercise. Eur J Appl Physiol. 2021 Mar;121(3):929-940. doi: 10.1007/s00421-020-04557-5. Epub 2021 Jan 8.

    PMID: 33417036DERIVED

MeSH Terms

Conditions

Diabetic CardiomyopathiesDiabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

CardiomyopathiesHeart DiseasesCardiovascular DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
prof. dr.

Study Record Dates

First Submitted

September 12, 2017

First Posted

October 3, 2017

Study Start

October 6, 2017

Primary Completion

December 31, 2019

Study Completion

September 30, 2020

Last Updated

December 10, 2020

Record last verified: 2020-12

Locations

BE(1)