Status:
UNKNOWN
The Clock Thickens: Morning or Evening Training for the Treatment of NAFLD?
Lead Sponsor:
Leiden University Medical Center
Collaborating Sponsors:
Maag Lever Darm Stichting
Conditions:
Non-Alcoholic Fatty Liver Disease
Eligibility:
All Genders
45-75 years
Phase:
NA
Brief Summary
The goal of this clinical trial is to investigate the different effect of morning and evening exercise training in individuals with non-alcoholic fatty liver disease (NAFLD). The main question it aims...
Detailed Description
The aim of the study is to identify the effect of exercise timing on NAFLD. Additionally, we aim to increase the understanding of the exercise-related modulation of the metabolic and inflammatory proc...
Eligibility Criteria
Inclusion
- Age ≥ 45 years and ≤ 75
- Obese (BMI \> 27 kg/m2)
- Males and postmenopausal females
- Caucasian
- Hepatic steatosis defined as increased hyperechogenicity of the liver on abdominal ultrasound, CAP score on Fibroscan \> 280, and/or histological signs of steatosis
- Sedentary lifestyle (maximum of 20 minutes of moderate-to-vigorous physical activity per day on less than three days per week)
- Written informed consent
Exclusion
- Exclusion criteria for MRI (claustrophobia, pacemaker, metal implants, etc.)
- Any other liver disease than NAFLD/NASH
- Present excessive alcohol use defined as \> 2 units/day
- Recent use (\< 3 months) of antibiotics
- Recent changes in dosages of regular medication (\< 3 months)
- Recent (\< 3 months) weight change (\>5%)
- Recent (\< 3 months) substantial diet changes
- Cardiovascular co-morbidity defined as heart failure, coronary insufficiency and hypertension in past history
- Comorbidity that contraindicates exercise training and exercise testing or that affects exercise response and exercise capacity
- Ongoing or recent use of glucocorticoids, oral/transdermal hormonal substitution, paclitaxel, theofyllin, amiodarone, myelosuppresive agents
- A psychiatric, addictive or any other disorder that compromises the subjects ability to understand the study content and to give written informed consent for participation in the study
- Working night or alternating shifts, known sleeping disorders such as narcolepsy or insomnia
Key Trial Info
Start Date :
September 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2024
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT05987748
Start Date
September 1 2023
End Date
September 1 2024
Last Update
August 14 2023
Active Locations (1)
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1
Leiden University Medical Center
Leiden, South Holland, Netherlands, 2333 ZA