Effects of Intermittent Fasting on Fatty Liver Disease
- Conditions
- Sensitivity to Thyroid HormonesMetabolic Parametersin Patients With FLD
- Registration Number
- NCT04795973
- Lead Sponsor
- Beijing Chao Yang Hospital
- Brief Summary
Eighty subjects with FLD were recruited from the endocrinology clinic at Beijing Chao-yang Hospital. All of the following inclusion criteria needed to be met: hepatic fat content (HFC) were upper 5.0% evaluated by upper abdominal MRI proton density fat fraction (MRI-PDFF) examinations, age ≥ 18 years, body mass index (BMI) ≥ 18.5 kg/m2, and stable body weight (change \< ± 10% of body weight) during the last 3 months. Participants underwent an 8-week 5:2 IF intervention. Metabolic parameters and thyroid hormone sensitivity indices were assessed at baseline and after intervention.
- Detailed Description
Eighty subjects with FLD were recruited from the endocrinology clinic at Beijing Chao-yang Hospital, Capital Medical University, China, between September 22, 2020 and April 30, 2021. Inclusion criteria were hepatic fat content (HFC) \> 5.0% evaluated by upper abdominal MRI proton density fat fraction (MRI-PDFF) examinations, age ≥ 18 years, body mass index (BMI) ≥ 18.5 kg/m2, and stable body weight (change \< ± 10% of body weight) during the last 3 months. Participants underwent an 8-week 5:2 IF intervention. Metabolic parameters and thyroid hormone sensitivity indices were assessed at baseline and after intervention.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 80
- hepatic fat content (HFC) > 5.0% evaluated by upper abdominal MRI proton density fat fraction (MRI-PDFF) examinations
- age ≥ 18 years
- body mass index (BMI) ≥ 18.5 kg/m2
- stable body weight (change < ± 10% of body weight) during the last 3 months
- plasma aspartate aminotransferase (AST) and alanine amino-transferase (ALT) levels exceeded 2.5 times of the upper limit of normal
- fasting blood glucose (FBG) levels ≥ 7.0 mmol/L or glycated hemoglobin A1c (HbA1c) ≥ 6.5%
- with type 1 or type 2 diabetes
- with heart disease
- with other hepatic disease (excluding FLD)
- with renal disease
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Body Mass Index (BMI, kg/m²) measured using digital scale and stadiometer 8 weeks BMI will be calculated as weight (kg) divided by height squared (m²). Weight will be measured on a calibrated digital scale and height using a stadiometer. Measurements will be taken at baseline and after the 8-week intermittent fasting intervention.
TSH Index (TSHI) calculated from serum TSH and FT4 levels 8 weeks Fasting venous blood samples will be collected at baseline and after the 8-week intermittent fasting intervention. Serum TSH and FT4 concentrations will be determined using a standardized automated immunoassay. TSH Index will be calculated according to published formulas.
Thyrotroph Thyroid Hormone Sensitivity Index (TTSI) calculated from serum TSH and FT4 levels 8 weeks Fasting blood samples will be collected at baseline and after the 8-week intermittent fasting intervention. Serum TSH and FT4 concentrations will be measured using a standardized automated immunoassay. TTSI will be calculated according to published formulas.
FT3/FT4 ratio calculated from serum FT3 and FT4 levels 8 weeks Fasting venous blood samples will be collected at baseline and after the 8-week intermittent fasting intervention. Serum FT3 and FT4 concentrations will be measured using a standardized automated immunoassay, and the FT3/FT4 ratio will be calculated as an index of peripheral thyroid hormone conversion efficiency.
Changes in metabolic parameters after 8-week IF intervention, measured using blood tests and biochemical assays. 8 weeks Lipid profile: Total cholesterol (TC), triglycerides (TG), low-density lipoprotein cholesterol (LDL-C), and high-density lipoprotein cholesterol (HDL-C) will be measured from fasting blood samples.
Glycated hemoglobin (HbA1c, %) will be measured using high-performance liquid chromatography (HPLC). Fasting glucose (mg/dL or mmol/L) will be measured using an enzymatic glucose oxidase method. Fasting insulin (μIU/mL) will be measured using an electrochemiluminescence immunoassay. All blood samples will be collected after an overnight fast at baseline and after the 8-week IF intervention.Changes in abdominal MRI findings (liver fat deposition) after 8-week IF intervention, assessed using magnetic resonance imaging 8 weeks Abdominal fat distribution and liver fat content will be assessed using magnetic resonance imaging (MRI). Scans will be performed at baseline and after the 8-week IF intervention.
- Secondary Outcome Measures
Name Time Method
Related Research Topics
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Trial Locations
- Locations (1)
Beijing Chao-yang Hospital, Capital Medical University
🇨🇳Beijing, Beijing Municipality, China
Beijing Chao-yang Hospital, Capital Medical University🇨🇳Beijing, Beijing Municipality, ChinaJia Liu, MDContact010-8523161710liujia0116@126.com