Sensitivity to Thyroid Hormones, Metabolic Parameters, in Patients With FLD
Conditions
Keywords
fatty liver disease, 5:2 intermittent fasting, thyroid hormone sensitivity, insulin sensitivity, weight loss
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.
Interventions
BEHAVIORAL5:2 intermittent fasting
All subjects received 5:2 IF. They followed a normal diet for 5 days each week and practiced IF for 2 days discontinuously. On normal eating days, women consumed 1200 to 1500 kcal/day and men consumed 1500 to 1800 kcal/day, with macro-nutrient distribution of 45% to 50% carbohydrate, 20% protein, and 30% to 35% fat. They consumed 500 kcal and at least 50 g of protein on a light fasting day. Noncaloric beverages like water and unsweetened tea were allowed without restriction. A nutritionist provided diet guidance and documented any discomfort symptoms throughout the study.
Sponsors
Beijing Chao Yang Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
China
Outcome results
None listed