Metabolic Dysfunction-associated Fatty Liver DiseaseNCT05974904
Association of HsCAR with MAFLD and Liver Fibrosis: a Cross-sectional Study
An observational study of Metabolic Dysfunction-associated Fatty Liver Disease and Hepatic Steatosis, run by Chongqing Medical University at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Metabolic Dysfunction-associated Fatty Liver Disease, Hepatic Steatosis, Liver Fibrosis
- What is being tested?
- high-sensitivity C-reactive protein to albumin ratio
- How many people
- 7,000 participants
- Where
- 1 siteChina
- Study dates
- 18 Jul 2023to 28 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: They all come from the National Health and Nutrition Examination Survey, which is a database that contains information about demographics, dietary, examination, laboratory and questionnaire of the American population obtained through sophisticated sampling strategies.
Who may be able to join
- 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)
Show all 12Show fewer
- 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
Who cannot join
- Liver ultrasound data not available
- participants without complete clinical data
- participants under 18 years old
- participants with cancer.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400000
Tingqiu Wang, Bachelor, 17815370539, w857683014@163.com
About this study
Official title: Association of High-sensitivity C-reactive Protein to Albumin Ratio with Metabolic Dysfunction-associated Fatty Liver Disease and Liver Fibrosis: a Cross-sectional Study
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?
Read the detailed description
Background Inflammation is related to the occurrence and development of fatty liver. Our research aimed to investigate the link between an inflammatory indicator, high-sensitivity C-reactive protein to albumin ratio (hsCAR), and metabolic dysfunction-associated fatty liver disease (MAFLD).
Methods Ultrasonic indices were used to evaluate the severity of liver steatosis and fibrosis of participants from the NHANES database, respectively. The relationship between hsCAR and MAFLD was explored using multivariate logistic regression analysis, restricted cubic splines (RCS) as well as threshold analysis. Finally, subgroup analyses were performed using the same methodology.
- Being tested
- high-sensitivity C-reactive protein to albumin ratio
- Keywords
- high-sensitivity C-reactive protein to albumin ratio, metabolic dysfunction-associated fatty liver disease, National Health and Nutrition Examination Survey, control attenuation parameter, liver stiffness measurement, inflammation
- Medical subject headings
- Fatty Liver, Liver Cirrhosis, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
high-sensitivity C-reactive protein to albumin ratioOther
High-sensitivity C-reactive protein to albumin ratio is an inflammatory indicator which can make a determination of disease severity.
| Study group | Role | What they receive |
|---|---|---|
| Non-MAFLD group | controlled attenuation parameter<274 dB/m | |
| MAFLD group | controlled attenuation parameter ≥ 274 dB/m Receives: Other: high-sensitivity C-reactive protein to albumin ratio | |
| Non-fibrosis group | liver stiffness measurement < 8.2 kPa | |
| Fibrosis group | liver stiffness measurement ≥ 8.2 kPa Receives: Other: high-sensitivity C-reactive protein to albumin ratio |
What is being measured
The primary outcome is the main question the study is designed to answer.
Controlled attenuation parameter
Controlled attenuation parameter is an ultrasound indicator measured by FibroScan to evaluate the degree of liver steatosis
Measured: at baseline
Secondary outcomes (1)
Liver stiffness measurement
Liver stiffness measurement is an ultrasound indicator measured by FibroScan to evaluate the degree of liver stiffness
Measured: at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2023
- Study start18 Jul 2023
- Primary completion28 Dec 2026 (estimated)
- Study completion28 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Metabolic Dysfunction-associated Fatty Liver DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 7,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chongqing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tingqiu Wang, Chongqing Medical University
- Investigators
- Tingqiu Wang, Bachelor, Study director, The Second Affiliated Hospital of Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05974904
- Sponsor's protocol ID
- ChongqingMUU
- Status last verified
- Feb 2025
- First submitted
- 21 Jul 2023
- Last updated
- 12 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Eslam M, Newsome PN, Sarin SK, Anstee QM, Targher G, Romero-Gomez M, Zelber-Sagi S, Wai-Sun Wong V, Dufour JF, Schattenberg JM, Kawaguchi T, Arrese M, Valenti L, Shiha G, Tiribelli C, Yki-Jarvinen H, Fan JG, Gronbaek H, Yilmaz Y, Cortez-Pinto H, Oliveira CP, Bedossa P, Adams LA, Zheng MH, Fouad Y, Chan WK, Mendez-Sanchez N, Ahn SH, Castera L, Bugianesi E, Ratziu V, George J. A new definition for metabolic dysfunction-associated fatty liver disease: An international expert consensus statement. J Hepatol. 2020 Jul;73(1):202-209. doi: 10.1016/j.jhep.2020.03.039. Epub 2020 Apr 8.
PubMed 32278004Eddowes PJ, Sasso M, Allison M, Tsochatzis E, Anstee QM, Sheridan D, Guha IN, Cobbold JF, Deeks JJ, Paradis V, Bedossa P, Newsome PN. Accuracy of FibroScan Controlled Attenuation Parameter and Liver Stiffness Measurement in Assessing Steatosis and Fibrosis in Patients With Nonalcoholic Fatty Liver Disease. Gastroenterology. 2019 May;156(6):1717-1730. doi: 10.1053/j.gastro.2019.01.042. Epub 2019 Jan 25.
PubMed 30689971Karimi A, Shobeiri P, Kulasinghe A, Rezaei N. Novel Systemic Inflammation Markers to Predict COVID-19 Prognosis. Front Immunol. 2021 Oct 22;12:741061. doi: 10.3389/fimmu.2021.741061. eCollection 2021.
PubMed 34745112
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of High-sensitivity C-reactive Protein to Albumin Ratio with Metabolic Dysfunction-associated Fatty Liver Disease and Liver Fibrosis: a Cross-sectional Study
- ClinicalTrials.gov ID
- NCT05974904
- Acronym / sponsor ID
- ChongqingMUU
- Keywords
- high-sensitivity C-reactive protein to albumin ratio, metabolic dysfunction-associated fatty liver disease, National Health and Nutrition Examination Survey, control attenuation parameter, liver stiffness measurement, inflammation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 7,000 participants (estimated)
- Lead sponsor
- Chongqing Medical UniversityUniversity, hospital or other
- Study start
- 18 Jul 2023 (actual)
- Primary completion
- 28 Dec 2026 (estimated)
- Study completion
- 28 Dec 2026 (estimated)
- First posted
- 3 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
Detailed description
Background Inflammation is related to the occurrence and development of fatty liver. Our research aimed to investigate the link between an inflammatory indicator, high-sensitivity C-reactive protein to albumin ratio (hsCAR), and metabolic dysfunction-associated fatty liver disease (MAFLD).
Methods Ultrasonic indices were used to evaluate the severity of liver steatosis and fibrosis of participants from the NHANES database, respectively. The relationship between hsCAR and MAFLD was explored using multivariate logistic regression analysis, restricted cubic splines (RCS) as well as threshold analysis. Finally, subgroup analyses were performed using the same methodology.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Non-MAFLD group | – | –controlled attenuation parameter<274 dB/m |
| MAFLD group | – | Other: high-sensitivity C-reactive protein to albumin ratiocontrolled attenuation parameter ≥ 274 dB/m |
| Non-fibrosis group | – | –liver stiffness measurement < 8.2 kPa |
| Fibrosis group | – | Other: high-sensitivity C-reactive protein to albumin ratioliver stiffness measurement ≥ 8.2 kPa |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- They all come from the National Health and Nutrition Examination Survey, which is a database that contains information about demographics, dietary, examination, laboratory and questionnaire of the American population obtained through sophisticated sampling strategies.
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (4 listed)
- Liver ultrasound data not available
- participants without complete clinical data
- participants under 18 years old
- participants with cancer.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| high-sensitivity C-reactive protein to albumin ratioHigh-sensitivity C-reactive protein to albumin ratio is an inflammatory indicator which can make a determination of disease severity. | Other | Fibrosis group, MAFLD group |
Primary outcome
Controlled attenuation parameter
Time frame: at baseline
Controlled attenuation parameter is an ultrasound indicator measured by FibroScan to evaluate the degree of liver steatosis
1 secondary outcome
Liver stiffness measurement
Time frame: at baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2025.
- Background: PubMed 32278004Eslam M, Newsome PN, Sarin SK, Anstee QM, Targher G, Romero-Gomez M, Zelber-Sagi S, Wai-Sun Wong V, Dufour JF, Schattenberg JM, Kawaguchi T, Arrese M, Valenti L, Shiha G, Tiribelli C, Yki-Jarvinen H, Fan JG, Gronbaek H, Yilmaz Y, Cortez-Pinto H, Oliveira CP, Bedossa P, Adams LA, Zheng MH, Fouad Y, Chan WK, Mendez-Sanchez N, Ahn SH, Castera L, Bugianesi E, Ratziu V, George J. A new definition for metabolic dysfunction-associated fatty liver disease: An international expert consensus statement. J Hepatol. 2020 Jul;73(1):202-209. doi: 10.1016/j.jhep.2020.03.039. Epub 2020 Apr 8.
- Background: PubMed 30689971Eddowes PJ, Sasso M, Allison M, Tsochatzis E, Anstee QM, Sheridan D, Guha IN, Cobbold JF, Deeks JJ, Paradis V, Bedossa P, Newsome PN. Accuracy of FibroScan Controlled Attenuation Parameter and Liver Stiffness Measurement in Assessing Steatosis and Fibrosis in Patients With Nonalcoholic Fatty Liver Disease. Gastroenterology. 2019 May;156(6):1717-1730. doi: 10.1053/j.gastro.2019.01.042. Epub 2019 Jan 25.
- Background: PubMed 34745112Karimi A, Shobeiri P, Kulasinghe A, Rezaei N. Novel Systemic Inflammation Markers to Predict COVID-19 Prognosis. Front Immunol. 2021 Oct 22;12:741061. doi: 10.3389/fimmu.2021.741061. eCollection 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tingqiu Wang, Bachelor study director
The Second Affiliated Hospital of Chongqing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metabolic Dysfunction-associated Fatty Liver Disease and Hepatic Steatosis, run by Chongqing Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tingqiu Wang, Bachelor (+8617815370539, w857683014@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Controlled attenuation parameter (time frame: at baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05974904, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2025.