Correlation Between Serum Nociceptin and Sympathetic Nerve Activity in Diabetic Patients With MAFLD (NCT07663682) | Clinical Trial Compass
CompletedNot Applicable
Correlation Between Serum Nociceptin and Sympathetic Nerve Activity in Diabetic Patients With MAFLD
China100 participantsStarted 2025-09-01
Plain-language 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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Correlation Coefficient between Serum Nociceptin Level and Sympathetic Nerve Activity
Timeframe: Baseline
Trial details
NCT IDNCT07663682
SponsorSecond Hospital of Shanxi Medical University