CPET-based HIIT for MAFLD

ConditionMetabolic Dysfunction-Associated Fatty Liver Disease

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age35-65

SponsorTang Yida

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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)

Trial design

Treatments tested in this trial

HIIT
No specific exercise intervention.

Treatment groups

54 Participants

are divided into 2 treatment groups

Sponsors and collaborators

Tang Yida

Lead sponsor

Peking University Third Hospital

Sponsor institution

Source ClinicalTrials.gov