CPET-based HIIT for MAFLD (NCT07177963) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
CPET-based HIIT for MAFLD
China54 participantsStarted 2025-09-08
Plain-language summary
High-intensity interval training (HIIT), as an individualized exercise training mode based on cardiopulmonary exercise testing (CPET), is characterized by high-intensity training sessions interspersed with short rest periods. The findings from recent trials suggest that in the management of metabolic dysfunction-associated fatty liver disease (MAFLD), compared with traditional aerobic exercise modes such as moderate-intensity continuous training, HIIT may achieve similar or even better effects in reducing liver fat content, increasing peak oxygen uptake, improving insulin resistance, and lowering blood pressure, despite requiring less time commitment and lower energy expenditure. However, there is currently no consensus regarding the formulation of HIIT exercise protocols.
Based on the lower limits of the current mainstream HIIT intensity, sets, and interval time parameters, this study aims to assess the effectiveness, safety, and feasibility of the current exercise prescription in improving MAFLD.
Who can participate
Age range
35 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
Adults age 35\~65 years Nonalcoholic fatty liver diagnosed by abdominal ultrasonography
In conjunction with at least one cardiometabolic risk factor:
* Overweight or Obesity: ≥ 24kg/m2，or waist circumference ≥ 90 cm in men and \> 85 cm in women, or excessive body fat mass
* Prediabetes or type 2 diabetes mellitus: HbA1c ≥ 5.7%, or fasting plasma glucose ≥ 6.1mmol/L, or 2-h plasma glucose during OGTT ≥ 7.8mmol/L
* Plasma triglycerides ≥ 1.7 mmol/L (\>-150 mg/dl) or lipid-lowering treatment
* HDL-cholesterol ≤ -1.0 mmol/L in men and ≤ -1.3 mmol/L in women or lipid-lowering treatment
* Blood pressure ≥ 130/85 mmHg or treatment for hypertension
Exclusion Criteria:
* Contraindications for Cardiopulmonary Exercise Testing
* The electrocardiogram (ECG) results during cardiopulmonary exercise testing (CPET) showed positive findings
* Receiving GLP-1 receptor agonists, SGLT-2i, or taking \>2 antihypertensive/hypoglycemic/lipid-lowering/ antiarrhythmic drugs
* Taking dietary supplements (e.g., fish oil products, over-the-counter diet pills, meal replacements)
* Mental illness
* Other liver diseases
* Movement disorder related diseases and lower limb motor injury in the past 6 months
* Pregnant, lactating or planning to become pregnant in the near future
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Liver fat content (%)
Timeframe: Baseline (week 0) , after complete post-training (week 8).