- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07513922
The Correlation Between hs CRP TG Triglycerides Glucose Index in NAFLD and Liver Fibrosis
Correlation Between hs CRP TG Triglycerides Glucose Index in NAFLD and Liver Fibrosis
Study Overview
Status
Conditions
Detailed Description
Non-Alcoholic Fatty Liver Disease (NAFLD) is the most prevalent chronic liver disease in the world, affecting one-fourth of the global population, and represents a serious public health issue. NAFLD encompasses a broad spectrum of liver abnormalities, ranging from simple hepatic steatosis, which is thought to be benign, to non-Alcoholic Steatohepatitis (NASH) without fibrosis and progressing to fibrotic NASH. The evolution of liver fibrosis results in irreversible architectural changes of the liver and can progress to Hepatocellular Carcinoma (HCC) (Sheka et al., 2020; Zhou et al., 2025). NAFLD is associated with an increased risk of systemic metabolic disorders, such as hyperuricemia, hyperlipidemia, IR, and hyperglycemia. These metabolic disorders, in combination with NAFLD, contribute to the risk of developing extrahepatic malignancies and cardiovascular diseases, which are the main causes of extrahepatic mortality (Li et al., 2022).
High-sensitivity C-reactive protein (hs-CRP) is a widely used biomarker for measuring systemic inflammation and is readily available for measurement. It is especially useful for identifying low-grade inflammation and has been associated with adverse health outcomes, including cardiovascular disease, metabolic syndrome, insulin resistance, and decreased physical function (Banait et al., 2022; Son et al., 2022). In addition, hs-CRP is a marker of pro-inflammatory cytokines such as interleukin-6 (IL- 6) and tumor necrosis factor-alpha (TNF-α), and it has been used as a useful and valid marker of inflammation in large-scale epidemiological studies (Banait et al., 2022). In addition, the C-reactive protein-triglyceride glucose index (CTI) is a composite index that integrates the triglyceride and glucose (TyG) index with hs-CRP, thus reflecting both insulin resistance and systemic inflammation. Previous studies have found that the CTI is linked to various diseases, such as coronary heart disease, depression, stroke, NAFLD, and liver fibrosis (Ruan et al., 2022 Recent research has helped elucidate the pathogenic roles of insulin resistance (IR) and inflammation in NAFLD. Patients with non-alcoholic steatohepatitis (NASH) are likely to have higher levels of high-sensitivity C-reactive protein (hs-CRP) and pro-inflammatory cytokines, which could contribute to chronic inflammation and disease progression. Moreover, systemic inflammation is known to play a pivotal role in the pathogenesis of advanced cirrhosis (Ling et al., 2023). The triglyceride-glucose (TyG) index, a non-invasive surrogate marker of insulin resistance, is strongly linked with the development and progression of hepatic steatosis and fibrosis. The combined high-sensitivity C-reactive protein and triglyceride glucose index (CTI), which combines TyG and hs-CRP, offers a comprehensive estimate that reflects both insulin resistance and inflammation (Ruan et al., 2022; Xu et al., 2024). However, there are only a limited number of studies with a limited number of patients that have addressed the Correlation between the hs-CRP-triglyceride glucose index and NAFLD and liver fibrosis.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Nourhan Sayed Jadelrab Alsayed, Resident
- Phone Number: 01156076721
- Email: nouralsayed999@gmail.com
Study Contact Backup
- Name: Nourhan Sayed Jadelrab Sayed Alsayed, Resident
- Phone Number: 01040888770
- Email: nouralsayed999@gmail.com
Study Locations
-
-
-
Asyut, Egypt
- Assiut University Hospital Assiut, Assiut Governorate
-
Contact:
- Nour Nourhan Sayed Jadelrab, Resident
- Phone Number: 01156076721
- Email: nouralsayed999@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Non-Alcoholic Fatty Liver Disease (NAFLD) is the most prevalent chronic liver disease in the world, affecting one-fourth of the global population, and represents a serious public health issue. NAFLD encompasses a broad spectrum of liver abnormalities, ranging from simple hepatic steatosis, which is thought to be benign, to non-Alcoholic Steatohepatitis (NASH) without fibrosis and progressing to fibrotic NASH. The evolution of liver fibrosis results in irreversible architectural changes of the liver and can progress to Hepatocellular Carcinoma (HCC) (Sheka et al., 2020; Zhou et al., 2025). NAFLD is associated with an increased risk of systemic metabolic disorders, such as hyperuricemia, hyperlipidemia, IR, and hyperglycemia. These metabolic disorders, in combination with NAFLD, contribute to the risk of developing extrahepatic malignancies and cardiovascular diseases, which are the main causes of extrahepatic mortality (Li et al., 2022).
High-sensitivity C-reactive protein
Description
Inclusion Criteria:
- Adults ≥18 years
- Available fasting labs: TG, fasting glucose, hs-CRP
- Valid liver assessment by VCTE (FibroScan LSM) and CAP or ultrasound-based steatosis assessment
Exclusion Criteria:
- 1- Significant alcohol intake (define using your local standard; commonly sex-specific thresholds) 2- Viral hepatitis (HBsAg positive and/or HCV RNA positive) 3- Other chronic liver diseases (autoimmune hepatitis, hemochromatosis, Wilson's, etc.) 4- Pregnancy
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Participants will be instructed to fast for 8-12 hours before blood sampling. Venous blood samples w
|
Participants will be instructed to fast for 8-12 hours before blood sampling. Venous blood samples will be collected in the morning and analyzed in a certified laboratory for:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Presence of NAFLD (defined by CAP ≥248 dB/m after exclusion of secondary causes).
Time Frame: 1Year
|
1Year
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Essam Mohamed Abdelaziz ali, Professor
- Principal Investigator: Ahmed Abdelfadeel Maghrraby hasdan, Lecturer
Publications and helpful links
General Publications
- Sheka AC, Adeyi O, Thompson J, Hameed B, Crawford PA, Ikramuddin S. Nonalcoholic Steatohepatitis: A Review. JAMA. 2020 Mar 24;323(12):1175-1183. doi: 10.1001/jama.2020.2298.
- Zhou Y,Lin H,Weng X,Dai H,Xu J
- Xu M,Zhang L,Xu D,Shi W,Zhang W
- Son DH,Song SA,Lee YJ
- Ruan GT,Xie HL,Zhang HY,Liu CA,Ge YZ,Zhang Q,Wang ZW,Zhang X,Tang M,Song MM,Zhang XW,Yang M,Chen YB,Yu KY,Deng L,Gong YZ,Hu W,Wang KH,Cong MH,Shi HP
- Ling Q,Chen J,Liu X,Xu Y,Ma J,Yu P,Zheng K,Liu F,Luo J
- Li Q,Han Y,Hu H,Zhuge Y
- Banait T,Wanjari A,Danade V,Banait S,Jain J
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Digestive System Diseases
- Liver Diseases
- Fibrosis
- Pathological Conditions, Signs and Symptoms
- Liver Cirrhosis
- Amino Acids, Peptides, and Proteins
- Proteins
- Lipids
- Polycyclic Compounds
- Enzymes
- Enzymes and Coenzymes
- Immunoproteins
- Blood Proteins
- Steroids
- Fused-Ring Compounds
- Acute-Phase Proteins
- Albumins
- Transaminases
- Nitrogenous Group Transferases
- Transferases
- Cholestenes
- Cholestanes
- Sterols
- Membrane Lipids
- Acyltransferases
- Aminoacyltransferases
- Alanine Transaminase
- Cholesterol
- gamma-Glutamyltransferase
- C-Reactive Protein
Other Study ID Numbers
- hs CRP TG Glucose index
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Liver Fibrosis
-
Instituto Ecuatoriano de Enfermedades DigestivasRecruitingFibrosis, Liver | Liver SteatosisEcuador
-
Alentis Therapeutics AGCompletedLiver Cirrhosis | Advanced Liver FibrosisUnited States, Germany, Romania, Slovakia
-
Bristol-Myers SquibbCompleted
-
University Hospital, AngersRecruitingScreening | Advanced Liver FibrosisFrance
-
Beijing Continent Pharmaceutical Co, Ltd.Shanghai General Hospital, Shanghai Jiao Tong University School of MedicineNot yet recruitingLiver Fibrosis | Liver Fibrosis in Chronic Hepatitis BChina
-
The Affiliated Hospital of Qingdao UniversityRecruitingLiver Fibrosis After Liver Transplantation | Multiparameter Magnetic Resonance ImagingChina
-
Assistance Publique - Hôpitaux de ParisUnknownLiver Fibrosis Progression in Chronic Liver DiseaseFrance
-
Regina Elena Cancer InstituteFederico II UniversityRecruiting
-
Shengjing HospitalEnrolling by invitationLiver Steatosis | Liver Fibrosis | Liver Fibrosis Progression in Chronic Liver Disease | Steatotic Liver Disease | Steatotic Liver Disease of Mixed Origin (MetALD)China
-
Gilead SciencesTerminatedLiver Fibrosis Due to NASHUnited States, Canada, France, Italy, Germany, Puerto Rico, Spain, United Kingdom