Type 2 Diabetes Mellitus (T2DM)NCT07632677
Diagnostic Value of the Liver Inflammation Index for MASH in Patients With T2DM and MAFLD
An observational study of Type 2 Diabetes Mellitus (T2DM) and MASH - Metabolic Dysfunction-Associated Steatohepatitis, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School at 22 sites in China.
Trial summary
This observational study aims to evaluate a new diagnostic tool, the Liver Inflammation Index, in detecting Metabolic Dysfunction-Associated Steatohepatitis (MASH) among adults who have both Type 2 Diabetes Mellitus (T2DM) and Metabolic Dysfunction-Associated Fatty Liver Disease (MAFLD). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes Mellitus (T2DM), MASH - Metabolic Dysfunction-Associated Steatohepatitis, Metabolic Dysfunction-associated Fatty Liver Disease
- How many people
- 10,000 participants
- Where
- 22 sitesChina
- Study dates
- 15 May 2026to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population consists of adult patients concurrently diagnosed with Type 2 Diabetes Mellitus (T2DM) and Metabolic Dysfunction-Associated Fatty Liver Disease (MAFLD). Participants will be continuously enrolled from both outpatient clinics and inpatient departments across 22 major research centers and tertiary hospitals located in various geographic regions of China. This cohort represents a real-world clinical population seeking routine medical care, health evaluations, or regular follow-ups for their metabolic and endocrine conditions. Data will be collected through both prospective clinical assessments and retrospective medical record reviews.
Who may be able to join
- Adults aged ≥18 years, with no restrictions on sex;
- Patients clinically diagnosed with metabolic dysfunction-associated fatty liver disease (MAFLD) according to the Chinese Society of Hepatology guideline Guidelines for the Prevention and Treatment of Metabolic Dysfunction-Associated (Nonalcoholic) Fatty Liver Disease (2024 Edition), and additionally diagnosed with type 2 diabetes mellitus (T2DM) based on the Chinese Guidelines for the Prevention and Treatment of Type 2 Diabetes Mellitus (2024 Edition).
Who cannot join
- Presence of unhealed wounds, scars, or other conditions in the right upper abdominal region that are unsuitable for ultrasonographic examination;
- Development of other liver diseases during follow-up, including viral hepatitis, drug-induced liver injury, autoimmune liver disease, alcoholic liver disease, or other chronic liver diseases;
- History of hepatic decompensation;
- History of hepatectomy or liver transplantation;
- History of other malignancies;
- Presence of vascular liver disease, cystic fibrosis-associated liver disease, sarcoidosis, polycystic liver disease, congenital or rare hereditary liver diseases, mechanical cholestasis, secondary sclerosing cholangitis, or heart failure accompanied by hepatic venous congestion;
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- History of transjugular intrahepatic portosystemic shunt (TIPS);
- Occurrence of acute hepatitis during follow-up (defined as alanine aminotransferase levels >5 times the upper limit of normal) or acute-on-chronic liver failure (ACLF);
- Clinical or subclinical hypothyroidism or hyperthyroidism.
Trial locations and contacts
22 sites in 1 country. Contact the study team or a site near you to ask about taking part.
22 sites in 1 country
China22 sites, 22 recruiting
- Recruiting
Department of Endocrinology, the First Affiliated Hospital of Bengbu Medical University
Bengbu, Anhui, 233004
Xiaolei Hu
- Recruiting
Department of Endocrinology, Zhujiang Hospital, Southern Medical University
Guangzhou, Guangdong, 510280
Jia Sun
- Recruiting
Department of Obesity and Metabolic Diseases, Panyu Hospital of Traditional Chinese Medicine
Guangzhou, Guangdong, 511495
Hui Li
- Recruiting
Department of Endocrinology, Hainan General Hospital
Haikou, Hainan, 570311
Kaining Chen
- Recruiting
Department of Endocrinology, Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310020
Jiaqiang Zhou
- Recruiting
Department of Endocrinology, the Second Affiliated Hospital of Anhui Medical University
Hefei, Anhui, 230601
Tianrong Pan
- Recruiting
Department of Endocrinology, the First Affiliated Hospital of University of South China
Hengyang, Hunan, 421001
Xinhua Xiao
- Recruiting
Department of Endocrinology, the Third People's Hospital of Yunnan Province
Kunming, Yunnan, 650011
Li Gui
- Recruiting
Department of Endocrinology, Endocrine and Metabolic Disease Medical Center,Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University
Nanjing, Jiangsu, 210008
Yan Bi, MD, PhD, 86-25-83-105302, biyan@nju.edu.cn
Jin Li, MD, PhD, 86-25-83-105302, jinli807@126.com
- Recruiting
Department of Endocrinology, the First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, 530021
Yingfen Qin
- Recruiting
Department of Endocrinology, the Affiliated Hospital of Qingdao University
Qingdao, Shandong, 266000
Yangang Wang
- Recruiting
Department of Endocrinology, ZhongShan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200000
Xiaoying Li, MD, PhD, 86-21-64041990, li.xiaoying@zs-hospital.sh.cn
- Recruiting
Department of Endocrinology, the Eighth Affiliated Hospital, Sun Yat-sen University
Shenzhen, Guangdong, 518033
Yunfeng Shen
- Recruiting
Department of Endocrinology, the First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215006
Bimin Shi, MD, PhD, 86-0512-65223637, shibimin@163.com
- Recruiting
Department of Metabolic Diseases and Weight Management, Weifang People's Hospital
Weifang, Shandong, 261000
Haixia Liu
- Recruiting
Department of Endocrinology, the First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325000
Hong Zhu
- Recruiting
Department of Endocrinology, Renmin Hospital of Wuhan University
Wuhan, Hubei, 430060
Ling Gao
- Recruiting
Department of Endocrinology, the Second Affiliated Hospital of Wannan Medical University
Wuhu, Anhui, 241000
Junfei Gu
- Recruiting
Department of Endocrinology and Metabolism, Xijing Hospital, Air Force Medical University
Xi’an, Shanxi, 710032
Xiangyang Liu
- Recruiting
Department of Endocrinology, Xuzhou Central Hospital
Xuzhou, Jiangsu, 221009
Houfa Geng
- Recruiting
Department of Endocrinology, the First Affiliated Hospital of Henan University of CM
Zhengzhou, Hennan, 450099
Suqin Shi
- Recruiting
Department of Endocrinology, the Affiliated Hospital of Zunyi Medical University
Zunyi, Guizhou, 563000
Xin Liao
About this study
Official title: A Multicenter Cross-Sectional Study Evaluating the Diagnostic Accuracy of the Liver Inflammation Index for Metabolic Dysfunction-Associated Steatohepatitis (MASH) in Patients With Concurrent Type 2 Diabetes Mellitus and Metabolic Dysfunction-Associated Fatty Liver Disease
This observational study aims to evaluate a new diagnostic tool, the Liver Inflammation Index, in detecting Metabolic Dysfunction-Associated Steatohepatitis (MASH) among adults who have both Type 2 Diabetes Mellitus (T2DM) and Metabolic Dysfunction-Associated Fatty Liver Disease (MAFLD).
Read the detailed description
This study is a national, multicenter, real-world, cross-sectional observational trial designed to assess the clinical utility and diagnostic accuracy of the Liver Inflammation Index for identifying Metabolic Dysfunction-Associated Steatohepatitis (MASH) in patients with concurrent Type 2 Diabetes Mellitus (T2DM) and Metabolic Dysfunction-Associated Fatty Liver Disease (MAFLD).
The study plans to enroll a total of 10,000 participants across 22 major research centers in China. Data collection will be split into a prospective cohort (9,000 patients) and a retrospective cohort (1,000 patients). Each participating center will enroll between 100 and 2,000 subjects.
Study Procedures and Data Collection:
For all eligible participants, researchers will systematically collect comprehensive clinical data. This includes general demographic information, detailed past medical history, physical examination findings, and lifestyle questionnaires (assessing diet, physical activity, smoking, and alcohol consumption). Clinical assessments will involve standard laboratory tests to calculate the Liver Inflammation Index. Additionally, participants will undergo vibration-controlled transient elastography (using the iLivTouch device) to obtain the Ultrasound Attenuation Parameter (UAP) for steatosis grading and Liver Stiffness Measurement (LSM) for fibrosis staging.
Study Objectives:
The primary objective is to investigate the distribution and alterations of the Liver Inflammation Index in the Chinese T2DM and MAFLD population, and to evaluate the overall detection rate of MASH within this cohort.
Secondary objectives focus on stratifying the MASH detection rate based on several clinical variables:
The presence of comorbidities (including cardiovascular disease, chronic kidney disease, obesity, dyslipidemia, and hypertension).
The degree of hepatic steatosis (S1, S2, and S3), as determined by UAP results.
The severity of liver fibrosis (F0-F1, F2, F3, and F4), as determined by LSM results.
Demographic stratifications, including age, gender, and geographic region within China.
Identification of predictive risk factors associated with MASH in this specific patient population.
Exploratory Endpoints:
The study will explore the impact of modifiable, adverse lifestyle factors on the prevalence of MASH. Furthermore, a 5-year retrospective data collection (where hospital records permit) will be conducted to analyze the relationship between the MASH detection rate and various Liver-Related Events (LREs). LREs are defined as the occurrence of any of the following: Model for End-Stage Liver Disease (MELD) score ≥ 15, liver-related mortality, liver transplantation, progression to hepatocellular carcinoma, esophagogastric variceal bleeding, or hepatic decompensation (including ascites, overt hepatic encephalopathy, bacterial infections, and non-obstructive jaundice).
- Conditions
- Type 2 Diabetes Mellitus (T2DM), MASH - Metabolic Dysfunction-Associated Steatohepatitis, Metabolic Dysfunction-associated Fatty Liver Disease
- Being tested
- iLivTouch (Vibration-controlled transient elastography)
- Keywords
- Type 2 Diabetes Mellitus, MASH, MAFLD, Liver inflammation index
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iLivTouch (Vibration-controlled transient elastography)Diagnostic test
A non-invasive diagnostic assessment performed using the iLivTouch device. This device simultaneously generates three key metrics: the Liver Inflammation Index (the primary target evaluated for its accuracy in detecting MASH), the Ultrasound Attenuation Parameter (UAP) for hepatic steatosis grading, and the Liver Stiffness Measurement (LSM) for fibrosis staging.
| Study group | Role | What they receive |
|---|---|---|
| T2DM with MAFLD | Not described Receives: Diagnostic Test: iLivTouch (Vibration-controlled transient elastography) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the overall detection rate of MASH in the Chinese T2DM and MAFLD population.
Measured: Baseline
Secondary outcomes (6)
Proportion of Participants with MASH Stratified by Comorbidities
To evaluate and compare the detection rate of Metabolic Dysfunction-Associated Steatohepatitis (MASH) among subgroups of patients with specific concurrent conditions, including cardiovascular disease, chronic kidney disease, obesity, dyslipidemia, and hypertension.
Measured: Baseline
Proportion of Participants with MASH Stratified by Hepatic Steatosis Grades
To analyze the differences in the detection rate of MASH across varying degrees of hepatic steatosis (mild [S1], moderate [S2], and severe [S3]), as determined by the Ultrasound Attenuation Parameter (UAP) via transient elastography.
Measured: Baseline
Proportion of Participants with MASH Stratified by Liver Fibrosis Stages
To assess the differences in the detection rate of MASH among patients with different stages of liver fibrosis (F0-F1, F2, F3, and F4), as classified by Liver Stiffness Measurement (LSM) via transient elastography.
Measured: Baseline
Demographic Variations in MASH Detection Rate
To determine the detection rate of MASH stratified by key demographic factors, specifically gender and predefined age groups, to identify potential population-specific distribution patterns.
Measured: Baseline
Geographic Variations in MASH Detection Rate Across China
To evaluate the regional differences in the detection rate of MASH among the enrolled cohort of T2DM and MAFLD patients across different geographical regions within China.
Measured: Baseline
Identification of Risk Factors Associated with MASH
To identify and evaluate independent demographic, clinical, and laboratory predictors (risk factors) associated with the presence of MASH using multivariable logistic regression modeling.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2026
- Study start15 May 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes Mellitus (T2DM)Studies of the same condition, open and under way.
- More trials run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Fudan University, The First Affiliated Hospital of Soochow University, Xuzhou Central Hospital, First Affiliated Hospital of Wenzhou Medical University, The First Affiliated Hospital of Bengbu Medical University, The Second Hospital of Anhui Medical University, The Affiliated Hospital of Qingdao University, Weifang People's Hospital, Panyu Hospital of Traditional Chinese Medicine, Southern Medical University, China, First Affiliated Hospital of Guangxi Medical University, Zunyi Medical College, The First Affiliated Hospital of Air Force Medical University, Hainan General Hospital, The Third People's Hospital of Yunnan Province, Sir Run Run Shaw Hospital, The First Affiliated Hospital of Henan University of Traditional Chinese Medicine, Eighth Affiliated Hospital, Sun Yat-sen University, Second Affiliated Hospital of Wannan Medical College, Renmin Hospital of Wuhan University, The First Affiliated Hospital of University of South China
- Responsible party
- Principal investigator, Yan Bi, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
- Investigators
- Yan Bi, MD,PhD, Principal investigator, Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07632677
- Sponsor's protocol ID
- 2026-0142-01
- Status last verified
- Jun 2026
- First submitted
- 23 May 2026
- Last updated
- 8 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified participant data may be timely shared with qualified researchers upon request, subject to review and approval.
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Cross-Sectional Study Evaluating the Diagnostic Accuracy of the Liver Inflammation Index for Metabolic Dysfunction-Associated Steatohepatitis (MASH) in Patients With Concurrent Type 2 Diabetes Mellitus and Metabolic Dysfunction-Associated Fatty Liver Disease
- ClinicalTrials.gov ID
- NCT07632677
- Acronym / sponsor ID
- 2026-0142-01
- Conditions
- Type 2 Diabetes Mellitus (T2DM), MASH - Metabolic Dysfunction-Associated Steatohepatitis, Metabolic Dysfunction-associated Fatty Liver Disease
- Keywords
- Type 2 Diabetes Mellitus, MASH, MAFLD, Liver inflammation index
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolUniversity, hospital or other
- Collaborators
- Fudan University, The First Affiliated Hospital of Soochow University, Xuzhou Central Hospital, First Affiliated Hospital of Wenzhou Medical University, The First Affiliated Hospital of Bengbu Medical University, The Second Hospital of Anhui Medical University, The Affiliated Hospital of Qingdao University, Weifang People's Hospital, Panyu Hospital of Traditional Chinese Medicine, Southern Medical University, China, First Affiliated Hospital of Guangxi Medical University, Zunyi Medical College, The First Affiliated Hospital of Air Force Medical University, Hainan General Hospital, The Third People's Hospital of Yunnan Province, Sir Run Run Shaw Hospital, The First Affiliated Hospital of Henan University of Traditional Chinese Medicine, Eighth Affiliated Hospital, Sun Yat-sen University, Second Affiliated Hospital of Wannan Medical College, Renmin Hospital of Wuhan University, The First Affiliated Hospital of University of South China
- Study start
- 15 May 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 8 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 evaluate a new diagnostic tool, the Liver Inflammation Index, in detecting Metabolic Dysfunction-Associated Steatohepatitis (MASH) among adults who have both Type 2 Diabetes Mellitus (T2DM) and Metabolic Dysfunction-Associated Fatty Liver Disease (MAFLD).
Detailed description
This study is a national, multicenter, real-world, cross-sectional observational trial designed to assess the clinical utility and diagnostic accuracy of the Liver Inflammation Index for identifying Metabolic Dysfunction-Associated Steatohepatitis (MASH) in patients with concurrent Type 2 Diabetes Mellitus (T2DM) and Metabolic Dysfunction-Associated Fatty Liver Disease (MAFLD).
The study plans to enroll a total of 10,000 participants across 22 major research centers in China. Data collection will be split into a prospective cohort (9,000 patients) and a retrospective cohort (1,000 patients). Each participating center will enroll between 100 and 2,000 subjects.
Study Procedures and Data Collection:
For all eligible participants, researchers will systematically collect comprehensive clinical data. This includes general demographic information, detailed past medical history, physical examination findings, and lifestyle questionnaires (assessing diet, physical activity, smoking, and alcohol consumption). Clinical assessments will involve standard laboratory tests to calculate the Liver Inflammation Index. Additionally, participants will undergo vibration-controlled transient elastography (using the iLivTouch device) to obtain the Ultrasound Attenuation Parameter (UAP) for steatosis grading and Liver Stiffness Measurement (LSM) for fibrosis staging.
Study Objectives:
The primary objective is to investigate the distribution and alterations of the Liver Inflammation Index in the Chinese T2DM and MAFLD population, and to evaluate the overall detection rate of MASH within this cohort.
Secondary objectives focus on stratifying the MASH detection rate based on several clinical variables:
The presence of comorbidities (including cardiovascular disease, chronic kidney disease, obesity, dyslipidemia, and hypertension).
The degree of hepatic steatosis (S1, S2, and S3), as determined by UAP results.
The severity of liver fibrosis (F0-F1, F2, F3, and F4), as determined by LSM results.
Demographic stratifications, including age, gender, and geographic region within China.
Identification of predictive risk factors associated with MASH in this specific patient population.
Exploratory Endpoints:
The study will explore the impact of modifiable, adverse lifestyle factors on the prevalence of MASH. Furthermore, a 5-year retrospective data collection (where hospital records permit) will be conducted to analyze the relationship between the MASH detection rate and various Liver-Related Events (LREs). LREs are defined as the occurrence of any of the following: Model for End-Stage Liver Disease (MELD) score ≥ 15, liver-related mortality, liver transplantation, progression to hepatocellular carcinoma, esophagogastric variceal bleeding, or hepatic decompensation (including ascites, overt hepatic encephalopathy, bacterial infections, and non-obstructive jaundice).
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| T2DM with MAFLD | – | Diagnostic Test: iLivTouch (Vibration-controlled transient elastography) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of adult patients concurrently diagnosed with Type 2 Diabetes Mellitus (T2DM) and Metabolic Dysfunction-Associated Fatty Liver Disease (MAFLD). Participants will be continuously enrolled from both outpatient clinics and inpatient departments across 22 major research centers and tertiary hospitals located in various geographic regions of China. This cohort represents a real-world clinical population seeking routine medical care, health evaluations, or regular follow-ups for their metabolic and endocrine conditions. Data will be collected through both prospective clinical assessments and retrospective medical record reviews.
Key inclusion criteria (2 listed)
- Adults aged ≥18 years, with no restrictions on sex;
- Patients clinically diagnosed with metabolic dysfunction-associated fatty liver disease (MAFLD) according to the Chinese Society of Hepatology guideline Guidelines for the Prevention and Treatment of Metabolic Dysfunction-Associated (Nonalcoholic) Fatty Liver Disease (2024 Edition), and additionally diagnosed with type 2 diabetes mellitus (T2DM) based on the Chinese Guidelines for the Prevention and Treatment of Type 2 Diabetes Mellitus (2024 Edition).
Key exclusion criteria (9 listed)
- Presence of unhealed wounds, scars, or other conditions in the right upper abdominal region that are unsuitable for ultrasonographic examination;
- Development of other liver diseases during follow-up, including viral hepatitis, drug-induced liver injury, autoimmune liver disease, alcoholic liver disease, or other chronic liver diseases;
- History of hepatic decompensation;
- History of hepatectomy or liver transplantation;
- History of other malignancies;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| iLivTouch (Vibration-controlled transient elastography)A non-invasive diagnostic assessment performed using the iLivTouch device. This device simultaneously generates three key metrics: the Liver Inflammation Index (the primary target evaluated for its accuracy in detecting MASH), the Ultrasound Attenuation Parameter (UAP) for hepatic steatosis grading, and the Liver Stiffness Measurement (LSM) for fibrosis staging. | Diagnostic test | T2DM with MAFLD |
Primary outcome
To evaluate the overall detection rate of MASH in the Chinese T2DM and MAFLD population.
Time frame: Baseline
6 secondary outcomes
Proportion of Participants with MASH Stratified by Comorbidities
Time frame: Baseline
Proportion of Participants with MASH Stratified by Hepatic Steatosis Grades
Time frame: Baseline
Proportion of Participants with MASH Stratified by Liver Fibrosis Stages
Time frame: Baseline
Demographic Variations in MASH Detection Rate
Time frame: Baseline
Geographic Variations in MASH Detection Rate Across China
Time frame: Baseline
Identification of Risk Factors Associated with MASH
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2026.
- Individual participant dataSharing planned: Yes. De-identified participant data may be timely shared with qualified researchers upon request, subject to review and approval.
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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.
Yan Bi, MD,PhD principal investigator
Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University
22 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 2 Diabetes Mellitus (T2DM) and MASH - Metabolic Dysfunction-Associated Steatohepatitis, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School at 22 sites 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 2 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 8 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 22 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yan Bi, MD,PhD (86-25-83-105302, biyan@nju.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the overall detection rate of MASH in the Chinese T2DM and MAFLD population. (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 8 Jun 2026; AzTrials last refreshed its copy on 7 Nov 2026.