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Prevention of Heart Failure in Type 2 Diabetes by Exercise Intervention

Study acronym: PROTECTION
StatusActive, Not Recruiting
PhaseNot applicable
Started
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Record status
This record was last updated September 25, 2024 (before its estimated June 1, 2026 completion). Its status may not reflect the trial's current state.

Record History

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  1. Primary endpoints: 1 to 2v3 Show 5 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Primary completion date: Mar 1, 2026 to Jun 1, 2026
    • Study completion date: Jun 1, 2026 to Dec 1, 2026
    • Secondary endpoints: 14 to 5
    • Site details revised at 2 of 2 sites
  2. Trial status: Not Yet Recruiting to Recruiting
    • Primary completion date: Mar 1, 2024 to Mar 1, 2026
    • Study sites: 0 to 2
    • Study completion date: Sep 1, 2024 to Jun 1, 2026
    v2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Hasselt University
31 trials monitored
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Diabetes
5,087 trials monitored
See 222 trials at risk
Type 2 Diabetes
2,231 trials monitored
See 111 trials at risk
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.
Trial Details
NCT Number NCT05023538
Lead Sponsor Hasselt University
Collaborators: Jessa Hospital, KU Leuven, University Ghent
Conditions
(from sponsor)		 Type 2 Diabetes
Related terms Diabetes Mellitus, Type 2, Motor Activity
Enrollment 182 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov