NCT05974904Recruiting
Association of HsCAR with MAFLD and Liver Fibrosis: a Cross-sectional Study
Association of High-sensitivity C-reactive Protein to Albumin Ratio with Metabolic Dysfunction-associated Fatty Liver Disease and Liver Fibrosis: a Cross-sectional Study
Source: ClinicalTrials.gov · Last updated 12 Feb 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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?
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 7000 (estimated)
- First submitted
- 21 Jul 2023
- Start date
- 18 Jul 2023
- Primary completion date
- 28 Dec 2026
- Lead sponsor
- Chongqing Medical University
- Diseases
- Fatty liver disease (MASLD/MASH)
- NCT number
- NCT05974904
What you commit to
- Study type: Observational
- Planned participants: 7000
- From 18 Jul 2023 to the primary completion date, 28 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- participants with cancer.
Age
- participants under 18 years old
Other
- Liver ultrasound data not available
- participants without complete clinical data
Who the study is looking for
- 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.
- 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).
- Overweight or obesity: defined as BMI≥25 kg/m2 in Caucasians or BMI≥23 kg/m2 in Asians
- 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
Age in the registry: 18 years to 90 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Second Affiliated Hospital of Chongqing Medical University Coordinator of this site? Confirm its status | Chongqing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.