NCT05023538Active, not recruiting
Prevention of Heart Failure in Type 2 Diabetes by Exercise Intervention
PROTECTION Study: PReventiOn of HearT Failure in Type 2 Diabetes by ExerCise InTerventION
Source: ClinicalTrials.gov · Last updated 25 Sept 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 182 (estimated)
- First submitted
- 24 Jun 2021
- Start date
- Mar 2022
- Primary completion date
- Jun 2026
- Lead sponsor
- Hasselt University
- Diseases
- Heart failure, Type 2 diabetes
- NCT number
- NCT05023538
What you commit to
- Study type: Interventional
- Planned participants: 182
- From Mar 2022 to the primary completion date, Jun 2026
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- exogenous insulin therapy
Other illness
- 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).
Who the study is looking for
- 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.
Age in the registry: 30 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Faculty of Rehabilitation Sciences and Physiotherapy, Hasselt University Coordinator of this site? Confirm its status | Hasselt | Belgium | Unknown status |
| Faculty of Movement and Rehabilitation Sciences Coordinator of this site? Confirm its status | Leuven | Belgium | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.