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Clinical Trials in Belgium / NCT05023538
Active, not recruiting Not applicable

Prevention of Heart Failure in Type 2 Diabetes by Exercise Intervention

NCT05023538 · tracked via the Priya Life Science Belgium tracker
Sponsor
Hasselt University
Phase
Not applicable
Started
2022-03-01
Last updated
2024-09-25

Condition(s) studied

Type 2 Diabetes

Investigational drug(s) / intervention(s)

Cycling

Cycling: Exercise on bicycle ergometer

Study summary

Global longitudinal strain emerged as an important predictive marker that could be assessed during echocardiography. It enabled the detection of subclinical myocardial systolic dysfunction, without observable reductions in cardiac output or left ventricular ejection fraction, often years before diabetes induced heart failure. In asymptomatic T2D patients with no history of cardiovascular disease, an impaired global longitudinal strain is a predictor of future adverse left ventricular remodeling and adverse cardiovascular events. Exercise training is a promising intervention to interfere in the diabetes induced heart failure pathophysiology. However, the impact of different exercise modalities (e.g. intensity and volume) on the global longitudinal strain in type 2 diabetes (T2D) is unknown.

Eligibility

Sex
ALL
Min age
30 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: * physically inactive (no participation in structured or unstructured physical activity (PA) and not reaching the recommended PA guidelines: initially based on the International Physical Activity Questionnaire ) * age between 30-75 years * blood HbA1c of 6-10% (if taking blood glucose lowering medication) or 6.5-10% without taking blood glucose lowering medication, and/or two-hour plasma glucose ≥11.1 mmol/L or ≥200 mg/dL following a 75g oral glucose load during OGTT. * women of child bearing age will be included into the trial. Exclusion Criteria: * exogenous insulin therapy * individuals suffering from any disease with significant impact on exercise intervention participation, such as: chronic heart disease or significant arrhythmias, cardiac events (myocardial infarction, coronary artery bypass graft, percutaneous coronary intervention), chronic obstructive pulmonary, cerebrovascular or peripheral vascular disease, severe hypertension (\>160/110 mmHg), cancer, severe neuropathy (limiting exercise participation).

Primary outcome measure(s)

  • mPAP/CO and mPAP/CO slope — at baseline and 6 months
    * Mean pulmonary artery pressure by cardiac output and by cardiac output slope * mPAP/CO slope will be calculated via measurement of LVOTdiameter, LVOT VTI and sPAP at three timepoints during exercise echocardiography. These timepoints are: rest, low intense exercise (HR\<100 before fusion of early and late mitral inflow (E \& A)), and high-intense exercise (RER 1.02-1.05).
  • Global longitudinal strain (%) — at baseline and 6 months
    Cardiac function evaluation by echocardiography at rest

Trial sites (2)

FacilityCityRegionStatus
Faculty of Rehabilitation Sciences and Physiotherapy, Hasselt University Hasselt Belgium
Faculty of Movement and Rehabilitation Sciences Leuven Belgium

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Other trials for the same condition

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Prevalence of NAFLD in T2DM Patients Active, not recruiting
A Research Study to Look at How Two Different Doses of CagriSema and One Dose of Semaglutide Help People Living With Obesity With or Without Type 2 Diabetes Lose Weight Recruiting
The Effect of Exercise on the Brain in Type 2 Diabetes Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05023538 on ClinicalTrials.gov ↗ ← All trials in Belgium