Diabetes Mellitus, Type 2NCT07663682
Correlation Between Serum Nociceptin and Sympathetic Nerve Activity in Diabetic Patients With MAFLD
An observational study of Diabetes Mellitus, Type 2 and Metabolic Associated Fatty Liver Disease, run by Second Hospital of Shanxi Medical University at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 2, Metabolic Associated Fatty Liver Disease
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2025to 15 Jun 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Second Hospital of Shanxi Medical University
Taiyuan, Shanxi, 030001
About this study
Official title: Correlation Between Serum Nociceptin and Sympathetic Nerve Activity in Patients With Diabetes Mellitus and Metabolic Associated Fatty Liver Disease
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.
Read the detailed description
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.
- Keywords
- Nociceptin, Sympathetic Nervous System, Diabetes Mellitus, MAFLD, Liver Fibrosis, Biomarker, Observational Study
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus, Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation Coefficient between Serum Nociceptin Level and Sympathetic Nerve Activity
Spearman's rank correlation coefficient between serum nociceptin concentration and serum norepinephrine level.
Measured: Baseline
Secondary outcomes (3)
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.
Measured: Baseline
Correlation Between Serum Nociceptin and Liver Function Parameters
Spearman's correlation between serum nociceptin and liver enzymes including ALT, AST, and GGT.
Measured: 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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2026
- Study start1 Sep 2025
- Primary completion5 Jun 2026
- Study completion15 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Second Hospital of Shanxi Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zheng Guo, Second Hospital of Shanxi Medical University
- Investigators
- Yi Han, PhD, Study director, Second Hospital of Shanxi Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07663682
- Sponsor's protocol ID
- HanYi20260617
- Status last verified
- Jun 2026
- First submitted
- 17 Jun 2026
- Last updated
- 23 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Serum Nociceptin and Sympathetic Nerve Activity in Patients With Diabetes Mellitus and Metabolic Associated Fatty Liver Disease
- ClinicalTrials.gov ID
- NCT07663682
- Acronym / sponsor ID
- HanYi20260617
- Keywords
- Nociceptin, Sympathetic Nervous System, Diabetes Mellitus, MAFLD, Liver Fibrosis, Biomarker, Observational Study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Second Hospital of Shanxi Medical UniversityUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 5 Jun 2026 (actual)
- Study completion
- 15 Jun 2026 (actual)
- First posted
- 23 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Correlation Coefficient between Serum Nociceptin Level and Sympathetic Nerve Activity
Time frame: Baseline
Spearman's rank correlation coefficient between serum nociceptin concentration and serum norepinephrine level.
3 secondary outcomes
Comparison of Serum Nociceptin Levels Between Groups
Time frame: Baseline
Correlation Between Serum Nociceptin and Liver Function Parameters
Time frame: Baseline
Correlation Between Serum Nociceptin and Liver Fibrosis Indices
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yi Han, PhD study director
Second Hospital of Shanxi Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, Type 2 and Metabolic Associated Fatty Liver Disease, run by Second Hospital of Shanxi Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation Coefficient between Serum Nociceptin Level and Sympathetic Nerve Activity (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2026; AzTrials last refreshed its copy on 6 Nov 2026.