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Blood protein may reveal hidden nerve damage in diabetes and fatty liver

NCT ID NCT07663682

Knowledge-focused Sponsor: Second Hospital of Shanxi Medical University Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This observational study investigates whether a substance in the blood called nociceptin is linked to overactive nerves in people who have both type 2 diabetes and metabolic fatty liver disease. Researchers will compare 50 patients with both conditions to 50 healthy volunteers, measuring nociceptin and a marker of nerve activity from a single blood sample. The goal is to see if nociceptin could serve as a simple biomarker for this common health problem. No treatments or experimental drugs are involved.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If a link is found, nociceptin could become a simple blood test to help diagnose or monitor this common combination of conditions.
What could go wrong
This is a small, early-stage observational study, not a treatment trial. It may find no meaningful correlation, and results may not apply to broader populations.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

100 people

The number who actually took part.

Started

Sep 2025

Finished

Jun 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

cirrhosis of liver diabetes mellitus metabolic dysfunction-associated steatotic liver disease type 2 diabetes mellitus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Diabetes mellitus type 2 Metabolic associated fatty liver disease

Contacts and locations

Locations

  • Second Hospital of Shanxi Medical University

    Taiyuan, Shanxi, 030001, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.