NCT05974904 Association of HsCAR with MAFLD and Liver Fibrosis: a Cross-sectional Study
| NCT ID | NCT05974904 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Chongqing Medical University |
| Condition | Metabolic Dysfunction-associated Fatty Liver Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 7,000 participants |
| Start Date | 2023-07-18 |
| Primary Completion | 2026-12-28 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 7,000 participants in total. It began in 2023-07-18 with a primary completion date of 2026-12-28.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this observational study is to investigate the associations between a novel inflammatory marker, high sensitivity C-reactiveprotein to albumin ratio (hsCAR), and steatosis and fibrosis of metabolic dysfunction-associated fatty liver disease (MAFLD). The main question\[s\] it aims to answer are: \[question 1\] Can hsCAR serve as a clinical indicator to determine whether a patient has MAFD? \[question 2\] Can hsCAR determine whether MAFLD patients are complicated with liver fibrosis?
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.
Contact & Investigator
Tingqiu Wang, Bachelor
STUDY DIRECTOR
The Second Affiliated Hospital of Chongqing Medical University
Frequently Asked Questions
Who can join the NCT05974904 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 90 Years, studying Metabolic Dysfunction-associated Fatty Liver Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05974904 currently recruiting?
Yes, NCT05974904 is actively recruiting participants. Contact the research team at w857683014@163.com for enrollment information.
Where is the NCT05974904 trial being conducted?
This trial is being conducted at Chongqing, China.
Who is sponsoring the NCT05974904 clinical trial?
NCT05974904 is sponsored by Chongqing Medical University. The principal investigator is Tingqiu Wang, Bachelor at The Second Affiliated Hospital of Chongqing Medical University. The trial plans to enroll 7,000 participants.