NCT07663682Completed
Correlation Between Serum Nociceptin and Sympathetic Nerve Activity in Diabetic Patients With MAFLD
Correlation Between Serum Nociceptin and Sympathetic Nerve Activity in Patients With Diabetes Mellitus and Metabolic Associated Fatty Liver Disease
Source: ClinicalTrials.gov · Last updated 23 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 100 (actual)
- First submitted
- 17 Jun 2026
- Start date
- 1 Sept 2025
- Primary completion date
- 5 Jun 2026
- Lead sponsor
- Second Hospital of Shanxi Medical University
- NCT number
- NCT07663682
What you commit to
- Study type: Observational
- Participants enrolled: 100
- From 1 Sept 2025 to the primary completion date, 5 Jun 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Use of medications affecting sympathetic nervous system activity (e.g., beta-blockers, alpha-blockers, centrally acting antihypertensives) within 2 weeks prior to enrollment.
- Acute infection or acute diabetic complications (e.g., ketoacidosis, hyperosmolar state) within 4 weeks prior to enrollment.
Other illness
- Other chronic liver diseases including viral hepatitis (HBV, HCV), autoimmune hepatitis, primary biliary cholangitis, or Wilson's disease.
- Diagnosis of any active malignancy.
Lab values
- Severe cardiac dysfunction (NYHA class III or IV) or severe renal impairment (eGFR \<30 mL/min/1.73m²).
Other
- Alcohol consumption \>30 g/day for males or \>20 g/day for females.
- Pregnancy or lactation.
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Second hospital of Shanxi Medical University Coordinator of this site? Confirm its status | Taiyuan | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.