Correlation Between Serum Nociceptin and Sympathetic Nerve Activity in Diabetic Patients With MAFLD

NCT07663682 | Completed

• 1 other identifier: HanYi20260617
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetes Mellitus, Type 2; Metabolic Associated Fatty Liver Disease

Keywords

Nociceptin; Sympathetic Nervous System; Diabetes Mellitus; MAFLD; Liver Fibrosis; Biomarker; Observational Study

Outcome Measures

Primary Outcomes (1)

• Correlation Coefficient between Serum Nociceptin Level and Sympathetic Nerve Activity

  Spearman's rank correlation coefficient between serum nociceptin concentration and serum norepinephrine level.

  Baseline

Secondary Outcomes (3)

• Comparison of Serum Nociceptin Levels Between Groups

  Baseline

• Correlation Between Serum Nociceptin and Liver Function Parameters

  Baseline

• Correlation Between Serum Nociceptin and Liver Fibrosis Indices

  Baseline

Study Arms (2)

Healthy Control Group

Participants without type 2 diabetes mellitus or metabolic associated fatty liver disease

T2DM with MAFLD Group

Participants with both type 2 diabetes mellitus and metabolic associated fatty liver disease

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• Age 18 to 75 years.
• Scheduled for elective laparoscopic cholecystectomy.
• Willing and able to provide written informed consent.
• For the T2DM with MAFLD group: diagnosis of type 2 diabetes mellitus per ADA criteria and MAFLD confirmed by imaging (ultrasound or transient elastography) or validated non-invasive surrogate markers.
• For the healthy control group: no history of diabetes mellitus and no evidence of MAFLD on imaging or laboratory assessment.

You may not qualify if:

• Alcohol consumption \>30 g/day for males or \>20 g/day for females.
• Other chronic liver diseases including viral hepatitis (HBV, HCV), autoimmune hepatitis, primary biliary cholangitis, or Wilson's disease.
• Use of medications affecting sympathetic nervous system activity (e.g., beta-blockers, alpha-blockers, centrally acting antihypertensives) within 2 weeks prior to enrollment.
• Severe cardiac dysfunction (NYHA class III or IV) or severe renal impairment (eGFR \<30 mL/min/1.73m²).
• Diagnosis of any active malignancy.
• Pregnancy or lactation.
• Acute infection or acute diabetic complications (e.g., ketoacidosis, hyperosmolar state) within 4 weeks prior to enrollment.

Sponsors & Collaborators

• Second Hospital of Shanxi Medical University: lead

Study Sites (1)

Second Hospital of Shanxi Medical University

Taiyuan, Shanxi, 030001, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum samples collected from peripheral venous blood (5 mL) will be processed by centrifugation at 3000 rpm for 15 minutes. The separated serum will be aliquoted into cryotubes and stored at -80°C until analysis. These biospecimens will be used for quantitative measurement of serum nociceptin and norepinephrine concentrations via enzyme-linked immunosorbent assay (ELISA). No DNA extraction will be performed.

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus; Liver Cirrhosis

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Yi Han, PhD

  Second Hospital of Shanxi Medical University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 17, 2026
• First Posted: June 23, 2026
• Study Start: September 1, 2025
• Primary Completion: June 5, 2026
• Study Completion: June 15, 2026
• Last Updated: June 23, 2026

Record last verified: 2026-06

Locations

CN (1)