Status:
NOT_YET_RECRUITING
CPET-based HIIT for MAFLD
Lead Sponsor:
Tang Yida
Conditions:
Metabolic Dysfunction-Associated Fatty Liver Disease
Eligibility:
All Genders
35-65 years
Phase:
NA
Brief 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...
Detailed Description
54 Participants aged 35-65 years with MAFLD will be randomized 1:1 to intervention or control. The intervention group will undertake home-based HIIT four times weekly for 8 weeks. Each session compris...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 8 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2026
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT07177963
Start Date
September 8 2025
End Date
April 30 2026
Last Update
September 17 2025
Active Locations (5)
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1
Beijing Ditan Hospital, Capital Medical University
Beijing, China
2
Beijing Friendship Hospital, Capital Medical University
Beijing, China
3
Beijing Youan Hospital, Capital Medical University
Beijing, China
4
Peking University Third Hospital
Beijing, China