Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:07 PM
Ignite Modification Date:
2025-12-24 @ 9:07 PM
NCT ID:
NCT05974904
Eligibility Criteria:
Inclusion Criteria:
* Total participants from NHANES 2017-2020
* Participants diagnosed with MAFLD. Metabolic dysfunction-associated fatty liver disease (MAFLD) is the term used to describe hepatic steatosis in the presence of metabolic abnormalities, excess weight, obesity, or type 2 diabetic mellitus.
1. Diagnosis of diabetes mellitus: (1) taking glucose-lowering drugs; (2) HbA1c ≥ 6.5% (48 mmol/mol); (3) fasting plasma glucose ≥ 7.0 mmol/L (126 mg/dL); (4) 2-hour plasma glucose (2hPG) ≥ 11.1 mmol/L (200 mg/dL).
2. Overweight or obesity: defined as BMI≥25 kg/m2 in Caucasians or BMI≥23 kg/m2 in Asians
3. If presence of at least two metabolic risk abnormalities:
* Waist circumference≥102/88 cm in Caucasian men and women (or≥90/80 cm in Asian men and women)
* Blood pressure≥130/85 mmHg or specific drug treatment
* Plasma triglycerides≥150 mg/dl (≥1.70 mmol/L) or specific drug treatment
* Plasma HDL-cholesterol \<40 mg/dl (\<1.0 mmol/L) for men and \<50 mg/dl (\<1.3 mmol/L) for women or specific drug treatment
* Prediabetes (i.e., fasting glucose levels 100 to 125 mg/dl \[5.6 to 6.9 mmol/L\], or 2-hour post-load glucose levels 140 to 199 mg/dl \[7.8 to 11.0 mmol\] or HbA1c 5.7% to 6.4% \[39 to 47 mmol/mol\])
* Homeostasis model assessment of insulin resistance score≥2.5
* Plasma high-sensitivity C-reactive protein level \>2 mg/L
Exclusion Criteria:
* Liver ultrasound data not available
* participants without complete clinical data
* participants under 18 years old
* participants with cancer.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
90 Years
Study:
NCT05974904
Study Brief:
Protocol Section:
NCT05974904