An observational study in Diabetes Mellitus, Type 2 and Metabolic Associated Fatty Liver Disease, sponsored by Second Hospital of Shanxi Medical University. Completed at 1 site in China. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-23.
Sponsored by Second Hospital of Shanxi Medical University · Observational
This observational study aims to investigate the relationship between serum nociceptin levels and sympathetic nervous system activity in patients with both type 2 diabetes mellitus (T2DM) and metabolic associated fatty liver disease (MAFLD). A total of 100 participants, aged 18 to 75 years, who are scheduled for laparoscopic cholecystectomy at our hospital will be enrolled. Participants will be divided into two groups: 50 patients with both T2DM and MAFLD, and 50 healthy controls without either condition. The main goals are to determine if nociceptin levels correlate with liver function, liver fibrosis severity, and sympathetic nerve activity. During a single study visit, a 5 mL blood sample will be collected to measure serum nociceptin and norepinephrine (a marker of sympathetic activity). Routine clinical data will also be retrieved from medical records. This study involves no experimental drugs or devices, and all participants will continue to receive standard care. The findings may identify nociceptin as a potential diagnostic biomarker for this comorbidity.
Background: Type 2 diabetes mellitus (T2DM) and metabolic associated fatty liver disease (MAFLD) frequently coexist and are both characterized by sympathetic nervous system overactivity. Nociceptin (N/OFQ), an endogenous ligand for the nociceptin receptor, has been implicated in central sympathetic regulation in preclinical studies; however, clinical data in patients with T2DM and MAFLD are lacking.
Objectives: This study aims to: (1) assess the correlation between serum nociceptin levels and sympathetic nerve activity (reflected by serum norepinephrine) in T2DM patients with MAFLD; (2) evaluate the association between nociceptin and liver function parameters (ALT, AST, GGT) and non-invasive fibrosis indices (FIB-4, NFS); and (3) compare serum nociceptin levels between the T2DM+MAFLD group and healthy controls.
Study Design: This is a single-center, cross-sectional, observational case-control study. We plan to enroll 100 participants undergoing elective laparoscopic cholecystectomy, aged 18-75 years. The case group (n=50) will consist of patients diagnosed with T2DM (ADA criteria) and MAFLD (based on imaging or validated surrogate markers). The control group (n=50) will be age- and sex-matched individuals without T2DM or MAFLD.
Study Procedures: On the morning of surgery, fasting peripheral venous blood (5 mL) will be collected. Samples will be centrifuged at 3000 rpm for 15 minutes to separate serum, which will then be aliquoted and stored at -80°C until analysis. Serum concentrations of nociceptin and norepinephrine will be measured using commercially available enzyme-linked immunosorbent assay (ELISA) kits. Routine clinical parameters, including liver function tests, lipid profiles, glycemic indices, and FIB-4/NFS scores, will be extracted from the hospital's electronic medical records.
Cost and Data Management: The costs of nociceptin and norepinephrine ELISA assays, as well as laboratory consumables, are covered by the research team's grant and personal funds. All routine clinical tests (liver function, biochemistry) are part of standard clinical care and are billed according to routine hospital policy. All data will be anonymized and securely stored.
Statistical Analysis: Data distribution will be tested for normality. Comparisons between groups will be performed using Student's t-test or Mann-Whitney U test as appropriate. Spearman's rank correlation analysis will be used to evaluate correlations between nociceptin and other continuous variables. Receiver operating characteristic (ROC) curves may be generated to explore the diagnostic utility of nociceptin. A two-sided P-value \<0.05 will be considered statistically significant.
9,359 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,318 are open to participants now.
This study's enrollment of 100 is below the median of 300 across 1,588 observational studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →Second Hospital of Shanxi Medical University is the lead sponsor of 27 studies on the registry; 15 are open to participants now.
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This study will enroll adult patients (aged 18-75 years) who are scheduled for elective laparoscopic cholecystectomy at the Second Hospital of Shanxi Medical University. Participants will be recruited from the hospital's general surgery and hepatobiliary surgery departments. The study population will consist of two groups: 50 patients with both type 2 diabetes mellitus and metabolic associated fatty liver disease (MAFLD), and 50 healthy controls without either condition. The recruitment will be consecutive, and participants will be screened based on medical history, laboratory results, and imaging findings to determine group assignment.
Exclusion Criteria:
Participants without type 2 diabetes mellitus or metabolic associated fatty liver disease
Participants with both type 2 diabetes mellitus and metabolic associated fatty liver disease
Correlation Coefficient between Serum Nociceptin Level and Sympathetic Nerve Activity
Spearman's rank correlation coefficient between serum nociceptin concentration and serum norepinephrine level.
Time frame: Baseline
Comparison of Serum Nociceptin Levels Between Groups
Comparison of serum nociceptin concentrations between the T2DM with MAFLD group and the healthy control group using the Mann-Whitney U test.
Time frame: Baseline
Correlation Between Serum Nociceptin and Liver Function Parameters
Spearman's correlation between serum nociceptin and liver enzymes including ALT, AST, and GGT.
Time frame: Baseline
Correlation Between Serum Nociceptin and Liver Fibrosis Indices
Spearman's correlation between serum nociceptin and non-invasive fibrosis indices including FIB-4 and NFS scores.
Time frame: Baseline
Plan to share: Undecided
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Second Hospital of Shanxi Medical University