Dose-response Association Between hsCAR and MAFLD: A Cross-sectional Study

Sponsor
Chongqing Medical University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05974904
Collaborator
(none)
7,000
1
10
21306.3

Study Details

Study Description

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?

Condition or Disease Intervention/Treatment Phase
  • Other: high-sensitivity C-reactive protein to albumin ratio

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

Study Type:
Observational
Anticipated Enrollment :
7000 participants
Observational Model:
Case-Control
Time Perspective:
Cross-Sectional
Official Title:
Dose-response Association Between High-sensitivity C-reactive Protein to Albumin Ratio and Metabolic Dysfunction-associated Fatty Liver Disease: A Cross-sectional Study
Actual Study Start Date :
Jul 18, 2023
Anticipated Primary Completion Date :
Jul 28, 2023
Anticipated Study Completion Date :
Jul 28, 2023

Arms and Interventions

Arm Intervention/Treatment
Non-MAFLD group

controlled attenuation parameter<274 dB/m

MAFLD group

controlled attenuation parameter ≥ 274 dB/m

Other: high-sensitivity C-reactive protein to albumin ratio
High-sensitivity C-reactive protein to albumin ratio is an inflammatory indicator which can make a determination of disease severity.

Non-fibrosis group

liver stiffness measurement < 8.2 kPa

Fibrosis group

liver stiffness measurement ≥ 8.2 kPa

Other: high-sensitivity C-reactive protein to albumin ratio
High-sensitivity C-reactive protein to albumin ratio is an inflammatory indicator which can make a determination of disease severity.

Outcome Measures

Primary Outcome Measures

  1. Controlled attenuation parameter [at baseline]

    Controlled attenuation parameter is an ultrasound indicator measured by FibroScan to evaluate the degree of liver steatosis

Secondary Outcome Measures

  1. Liver stiffness measurement [at baseline]

    Liver stiffness measurement is an ultrasound indicator measured by FibroScan to evaluate the degree of liver stiffness

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 90 Years
Sexes Eligible for Study:
All
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 The Second Affiliated Hospital of Chongqing Medical University Chongqing Chongqing China 400000

Sponsors and Collaborators

  • Chongqing Medical University

Investigators

  • Study Director: Tingqiu Wang, Bachelor, The Second Affiliated Hospital of Chongqing Medical University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Tingqiu Wang, Principal Investigator, Chongqing Medical University
ClinicalTrials.gov Identifier:
NCT05974904
Other Study ID Numbers:
  • ChongqingMUU
First Posted:
Aug 3, 2023
Last Update Posted:
Aug 3, 2023
Last Verified:
Aug 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Tingqiu Wang, Principal Investigator, Chongqing Medical University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 3, 2023