Liver FibrosisNCT07513922
The Correlation Between hs CRP TG Triglycerides Glucose Index in NAFLD and Liver Fibrosis
An observational study of Liver Fibrosis, run by Assiut University at 1 site in Egypt.
Trial summary
The Correlation between hs CRP TG triglycerides Glucose index in NAFLD and liver fibrosis Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Liver Fibrosis
- What is being tested?
- • Fasting triglycerides (TG) • Fasting plasma glucose • High-sensitivity C-reactive protein (hs-CRP) • Liver enzymes (ALT, AST, GGT) • Platelet count • HbA1c • Lipid profile (total cholesterol, HDL-C,
- How many people
- 96 participants
- Where
- 1 siteEgypt
- Study dates
- 2 Oct 2026to 2 Dec 2027
- How long will I take part?
- 1 Year
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Assiut University Hospital Assiut, Assiut Governorate
Asyut
Nour Nourhan Sayed Jadelrab, Resident, 01156076721, nouralsayed999@gmail.com
About this study
Official title: Correlation Between hs CRP TG Triglycerides Glucose Index in NAFLD and Liver Fibrosis
The Correlation between hs CRP TG triglycerides Glucose index in NAFLD and liver fibrosis
Read the 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.
- Conditions
- Liver Fibrosis
- Being tested
- • Fasting triglycerides (TG) • Fasting plasma glucose • High-sensitivity C-reactive protein (hs-CRP) • Liver enzymes (ALT, AST, GGT) • Platelet count • HbA1c • Lipid profile (total cholesterol, HDL-C,
- Medical subject headings
- Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
• Fasting triglycerides (TG) • Fasting plasma glucose • High-sensitivity C-reactive protein (hs-CRP) • Liver enzymes (ALT, AST, GGT) • Platelet count • HbA1c • Lipid profile (total cholesterol, HDL-C,Other
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:
- Fasting triglycerides (TG)
- Fasting plasma glucose
- High-sensitivity C-reactive protein (hs-CRP)
- Liver enzymes (ALT, AST, GGT)
- Platelet count
- HbA1c
- Lipid profile (total cholesterol, HDL-C, LDL-C)
| Study group | Role | What they receive |
|---|---|---|
| Participants will be instructed to fast for 8-12 hours before blood sampling. Venous blood samples w | Not described Receives: Other: • Fasting triglycerides (TG) • Fasting plasma glucose • High-sensitivity C-reactive protein (hs-CRP) • Liver enzymes (ALT, AST, GGT) • Platelet count • HbA1c • Lipid profile (total cholesterol, HDL-C, |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of NAFLD (defined by CAP ≥248 dB/m after exclusion of secondary causes).
Measured: 1Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2026
- Study start2 Oct 2026 (estimated)
- Primary completion2 Oct 2027 (estimated)
- Study completion2 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Liver FibrosisStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 96 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nourhan Sayed Jadelrab Sayed, Assiut University
- Investigators
- Essam Mohamed Abdelaziz ali, Professor, Principal investigatorAhmed Abdelfadeel Maghrraby hasdan, Lecturer, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07513922
- Sponsor's protocol ID
- hs CRP TG Glucose index
- Status last verified
- Mar 2026
- First submitted
- 31 Mar 2026
- Last updated
- 7 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhou Y, Lin H, Weng X, Dai H, Xu J. Correlation between hs-CRP-triglyceride glucose index and NAFLD and liver fibrosis. BMC Gastroenterol. 2025 Apr 12;25(1):252. doi: 10.1186/s12876-025-03870-7.
PubMed 40221654Xu M, Zhang L, Xu D, Shi W, Zhang W. Usefulness of C-reactive protein-triglyceride glucose index in detecting prevalent coronary heart disease: findings from the National Health and Nutrition Examination Survey 1999-2018. Front Cardiovasc Med. 2024 Oct 15;11:1485538. doi: 10.3389/fcvm.2024.1485538. eCollection 2024.
PubMed 39473894Son DH, Song SA, Lee YJ. Association Between C-Reactive Protein and Relative Handgrip Strength in Postmenopausal Korean Women Aged 45-80 Years: A Cross-Sectional Study. Clin Interv Aging. 2022 Jun 17;17:971-978. doi: 10.2147/CIA.S356947. eCollection 2022.
PubMed 35747693Sheka 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.
PubMed 32207804Ruan 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. A Novel Inflammation and Insulin Resistance Related Indicator to Predict the Survival of Patients With Cancer. Front Endocrinol (Lausanne). 2022 Jun 20;13:905266. doi: 10.3389/fendo.2022.905266. eCollection 2022.
PubMed 35795140Ling Q, Chen J, Liu X, Xu Y, Ma J, Yu P, Zheng K, Liu F, Luo J. The triglyceride and glucose index and risk of nonalcoholic fatty liver disease: A dose-response meta-analysis. Front Endocrinol (Lausanne). 2023 Jan 19;13:1043169. doi: 10.3389/fendo.2022.1043169. eCollection 2022.
PubMed 36743937Li Q, Han Y, Hu H, Zhuge Y. Gamma-glutamyl transferase to high-density lipoprotein cholesterol ratio has a non-linear association with non-alcoholic fatty liver disease: A secondary prospective cohort study in non-obese Chinese adults. Front Med (Lausanne). 2022 Nov 17;9:995749. doi: 10.3389/fmed.2022.995749. eCollection 2022.
PubMed 36465946Banait T, Wanjari A, Danade V, Banait S, Jain J. Role of High-Sensitivity C-reactive Protein (Hs-CRP) in Non-communicable Diseases: A Review. Cureus. 2022 Oct 12;14(10):e30225. doi: 10.7759/cureus.30225. eCollection 2022 Oct.
PubMed 36381804
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between hs CRP TG Triglycerides Glucose Index in NAFLD and Liver Fibrosis
- ClinicalTrials.gov ID
- NCT07513922
- Acronym / sponsor ID
- hs CRP TG Glucose index
- Conditions
- Liver Fibrosis
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 2 Oct 2026 (estimated)
- Primary completion
- 2 Oct 2027 (estimated)
- Study completion
- 2 Dec 2027 (estimated)
- First posted
- 7 Apr 2026 (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 Correlation between hs CRP TG triglycerides Glucose index in NAFLD and liver fibrosis
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants will be instructed to fast for 8-12 hours before blood sampling. Venous blood samples w | – | Other: • Fasting triglycerides (TG) • Fasting plasma glucose • High-sensitivity C-reactive protein (hs-CRP) • Liver enzymes (ALT, AST, GGT) • Platelet count • HbA1c • Lipid profile (total cholesterol, HDL-C, |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- 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
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 |
|---|---|---|
| • Fasting triglycerides (TG) • Fasting plasma glucose • High-sensitivity C-reactive protein (hs-CRP) • Liver enzymes (ALT, AST, GGT) • Platelet count • HbA1c • Lipid profile (total cholesterol, HDL-C,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: * Fasting triglycerides (TG) * Fasting plasma glucose * High-sensitivity C-reactive protein (hs-CRP) * Liver enzymes (ALT, AST, GGT) * Platelet count * HbA1c * Lipid profile (total cholesterol, HDL-C, LDL-C) | Other | Participants will be instructed to fast for 8-12 hours before blood sampling. Venous blood samples w |
Primary outcome
Presence of NAFLD (defined by CAP ≥248 dB/m after exclusion of secondary causes).
Time frame: 1Year
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 7 Apr 2026.
- Background: PubMed 40221654Zhou Y, Lin H, Weng X, Dai H, Xu J. Correlation between hs-CRP-triglyceride glucose index and NAFLD and liver fibrosis. BMC Gastroenterol. 2025 Apr 12;25(1):252. doi: 10.1186/s12876-025-03870-7.
- Results publication: PubMed 39473894Xu M, Zhang L, Xu D, Shi W, Zhang W. Usefulness of C-reactive protein-triglyceride glucose index in detecting prevalent coronary heart disease: findings from the National Health and Nutrition Examination Survey 1999-2018. Front Cardiovasc Med. 2024 Oct 15;11:1485538. doi: 10.3389/fcvm.2024.1485538. eCollection 2024.
- Results publication: PubMed 35747693Son DH, Song SA, Lee YJ. Association Between C-Reactive Protein and Relative Handgrip Strength in Postmenopausal Korean Women Aged 45-80 Years: A Cross-Sectional Study. Clin Interv Aging. 2022 Jun 17;17:971-978. doi: 10.2147/CIA.S356947. eCollection 2022.
- Results publication: PubMed 32207804Sheka 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.
- Results publication: PubMed 35795140Ruan 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. A Novel Inflammation and Insulin Resistance Related Indicator to Predict the Survival of Patients With Cancer. Front Endocrinol (Lausanne). 2022 Jun 20;13:905266. doi: 10.3389/fendo.2022.905266. eCollection 2022.
- Results publication: PubMed 36743937Ling Q, Chen J, Liu X, Xu Y, Ma J, Yu P, Zheng K, Liu F, Luo J. The triglyceride and glucose index and risk of nonalcoholic fatty liver disease: A dose-response meta-analysis. Front Endocrinol (Lausanne). 2023 Jan 19;13:1043169. doi: 10.3389/fendo.2022.1043169. eCollection 2022.
- Results publication: PubMed 36465946Li Q, Han Y, Hu H, Zhuge Y. Gamma-glutamyl transferase to high-density lipoprotein cholesterol ratio has a non-linear association with non-alcoholic fatty liver disease: A secondary prospective cohort study in non-obese Chinese adults. Front Med (Lausanne). 2022 Nov 17;9:995749. doi: 10.3389/fmed.2022.995749. eCollection 2022.
- Results publication: PubMed 36381804Banait T, Wanjari A, Danade V, Banait S, Jain J. Role of High-Sensitivity C-reactive Protein (Hs-CRP) in Non-communicable Diseases: A Review. Cureus. 2022 Oct 12;14(10):e30225. doi: 10.7759/cureus.30225. eCollection 2022 Oct.
- 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.
Essam Mohamed Abdelaziz ali, Professor principal investigator
Ahmed Abdelfadeel Maghrraby hasdan, Lecturer principal investigator
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 Liver Fibrosis, run by Assiut University at 1 site in Egypt.
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 3 inclusion and 1 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: opening soon, as of the sponsor's last update on 7 Apr 2026. 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 Egypt. 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 Nourhan Sayed Jadelrab Alsayed, Resident (01156076721, nouralsayed999@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of NAFLD (defined by CAP ≥248 dB/m after exclusion of secondary causes). (time frame: 1Year). 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 NCT07513922, which also lists 8 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 7 Apr 2026.