NCT06359444 Effect of High Intensity Exercise Rehabilitation on Liver Function and Insulin Sensitivity in Patients With MASLD
| NCT ID | NCT06359444 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Ghent |
| Condition | Exercise Therapy |
| Study Type | INTERVENTIONAL |
| Enrollment | 92 participants |
| Start Date | 2024-04-26 |
| Primary Completion | 2026-03-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 92 participants in total. It began in 2024-04-26 with a primary completion date of 2026-03-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Metabolic dysfunction-associated steatotic liver disease (MASLD) is the most common liver disease worldwide, and is associated with obesity and the metabolic syndrome. Physical activity and lifestyle interventions are among the most recommended treatments for individuals with MASLD. In this RCT, we will evaluate the effect of combined exercise training "strength and aerobic training" versus "strength and high intensity training (HIIT)". The main outcome parameter is the severity of liver steatosis. Patients will be recruited at the fatty liver clinic of the UZ Gent.
Eligibility Criteria
Inclusion Criteria: * Diagnosed with MASLD by ultrasound, CAP and/or biopsy * Age between 18 and 75 years old * No significant liver fibrosis (Fibroscan \< 7.5 kPa; if it is between \>7.5 and \<10, there must be absence of liver fibrosis in the biopsy) Exclusion Criteria: * Presence of other liver diseases that may contribute to the clinical presentation in the patient * Severe cardiovascular, orthopedic, physical or other illnesses that make it impossible to participate in the study's exercise rehabilitation program or where safety cannot be guaranteed * Pregnancy * Pharmacological treatment that directly affects MASLD (e.g. GLP-1 analogues) * A change in medication in the last three months before the study that affects metabolic disease stability
Contact & Investigator
Patrick Calders, Prof. dr.
PRINCIPAL INVESTIGATOR
University Ghent
Frequently Asked Questions
Who can join the NCT06359444 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Exercise Therapy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06359444 currently recruiting?
Yes, NCT06359444 is actively recruiting participants. Contact the research team at patrick.calders@ugent.be for enrollment information.
Where is the NCT06359444 trial being conducted?
This trial is being conducted at Ghent, Belgium.
Who is sponsoring the NCT06359444 clinical trial?
NCT06359444 is sponsored by University Ghent. The principal investigator is Patrick Calders, Prof. dr. at University Ghent. The trial plans to enroll 92 participants.