Metabolic Dysfunction-Associated Steatotic Liver DiseaseNCT07001865
Metabolically Healthy Obesity Increases the Risks of MASLD and Hyperuricemia
An observational study of Metabolic Dysfunction-Associated Steatotic Liver Disease and Metabolically Healthy Obesity, run by Ningbo No. 1 Hospital at 1 site in China.
Trial summary
Although metabolically healthy obesity (MHO) is often considered a relatively benign obesity, its association with the risk of metabolic dysfunction-associated steatotic liver disease (MASLD) and hyperuricemia remains unclear. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolic Dysfunction-Associated Steatotic Liver Disease, Metabolically Healthy Obesity, Hyperuricemia
- How many people
- 17,040 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2025to 31 Dec 2025
- 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 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: This cohort study included participants who underwent comprehensive health examinations at the Physical Examination Center of the First Affiliated Hospital of Ningbo University between 2017 and 2024. A total of 18,261 individuals aged 18 years or older who completed abdominal ultrasound examinations were initially considered. After excluding underweight individuals (BMI < 18.5 kg/m²; N = 1,138) and those with missing data on height, weight, or metabolic syndrome (MetS) components (N = 83), 17,040 participants remained eligible for further analysis.For the MASLD incidence analysis, individuals with a baseline diagnosis of MASLD or other liver diseases (N = 5,328) were excluded, resulting in 11,712 participants. For the hyperuricemia incidence analysis, those with baseline hyperuricemia (N = 3,194) were further excluded, yielding 13,846 eligible participants. During a median follow-up period of up to 7 years, 3,756 incident cases of MASLD and 3,294 incident cases of hyperuricemia were
Who may be able to join
- Underwent comprehensive health examinations at the Physical Examination Center of the First Affiliated Hospital of Ningbo University between 2017 and 2024;
- Aged 18 years or older at baseline;
- Completed an abdominal ultrasound examination during the health check-up.
Who cannot join
- Underweight status at baseline, defined as BMI < 18.5 kg/m² ；
- Missing data on height, weight, or components of the metabolic syndrome ;
- Baseline diagnosis of MASLD or any other liver diseases
- Baseline diagnosis of hyperuricemia
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
the First Affiliated Hospital of Ningbo University Ningbo, Zhejiang, China, 315000, Ningbo, Zhejiang Province 315000 Recruiting
Ningbo
About this study
Official title: Metabolically Healthy Obesity Increases the Risks of MASLD and Hyperuricemia: A Cohort Study With Mediation Analysis
Although metabolically healthy obesity (MHO) is often considered a relatively benign obesity, its association with the risk of metabolic dysfunction-associated steatotic liver disease (MASLD) and hyperuricemia remains unclear. This study examined the associations between MHO and other metabolic-obesity phenotypes with MASLD and hyperuricemia, and explored the mediating roles of metabolic indicators.This study included 11,712 and 13,846 participants from a health examination cohort at the First Affiliated Hospital of Ningbo University for MASLD and hyperuricemia analyses, respectively. Participants were classified into four metabolic-obesity phenotypes, with MHO defined as obesity without metabolic syndrome components. The outcomes were MASLD and hyperuricemia. Cox regression and mediation analyses were conducted to assess associations and mediating effects.
- Conditions
- Metabolic Dysfunction-Associated Steatotic Liver Disease, Metabolically Healthy Obesity, Hyperuricemia
- Medical subject headings
- Obesity, Metabolically Benign, Hyperuricemia
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 |
|---|---|---|
| MASLD cohort | participants with non-MASLD at baseline | |
| Hyperuricemia | participants with non-Hyperuricemia at baseline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of MASLD and Hyperuricemia
through study completion
Measured: 7 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2025
- Study start1 Apr 2025
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metabolic Dysfunction-Associated Steatotic Liver DiseaseStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 17,040 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ningbo No. 1 Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07001865
- Sponsor's protocol ID
- 2025-073RS-01
- Other IDs
- MR-33-25-026108
- Status last verified
- May 2025
- First submitted
- 25 May 2025
- Last updated
- 3 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Liu Y, Qian T, Zheng Y, Liu A, Xu L, Ye G, Xie J. Metabolically healthy obesity increases the risks of MASLD and hyperuricemia: a cohort study with mediation analysis. BMC Endocr Disord. 2025 Nov 27;26(1):3. doi: 10.1186/s12902-025-02106-9.
PubMed 41310554
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolically Healthy Obesity Increases the Risks of MASLD and Hyperuricemia: A Cohort Study With Mediation Analysis
- ClinicalTrials.gov ID
- NCT07001865
- Acronym / sponsor ID
- 2025-073RS-01
- Conditions
- Metabolic Dysfunction-Associated Steatotic Liver Disease, Metabolically Healthy Obesity, Hyperuricemia
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 17,040 participants (estimated)
- Lead sponsor
- Ningbo No. 1 HospitalUniversity, hospital or other
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 3 Jun 2025 (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.
Although metabolically healthy obesity (MHO) is often considered a relatively benign obesity, its association with the risk of metabolic dysfunction-associated steatotic liver disease (MASLD) and hyperuricemia remains unclear. This study examined the associations between MHO and other metabolic-obesity phenotypes with MASLD and hyperuricemia, and explored the mediating roles of metabolic indicators.This study included 11,712 and 13,846 participants from a health examination cohort at the First Affiliated Hospital of Ningbo University for MASLD and hyperuricemia analyses, respectively. Participants were classified into four metabolic-obesity phenotypes, with MHO defined as obesity without metabolic syndrome components. The outcomes were MASLD and hyperuricemia. Cox regression and mediation analyses were conducted to assess associations and mediating effects.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MASLD cohort | – | –participants with non-MASLD at baseline |
| Hyperuricemia | – | –participants with non-Hyperuricemia at baseline |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- This cohort study included participants who underwent comprehensive health examinations at the Physical Examination Center of the First Affiliated Hospital of Ningbo University between 2017 and 2024. A total of 18,261 individuals aged 18 years or older who completed abdominal ultrasound examinations were initially considered. After excluding underweight individuals (BMI < 18.5 kg/m²; N = 1,138) and those with missing data on height, weight, or metabolic syndrome (MetS) components (N = 83), 17,040 participants remained eligible for further analysis.For the MASLD incidence analysis, individuals with a baseline diagnosis of MASLD or other liver diseases (N = 5,328) were excluded, resulting in 11,712 participants. For the hyperuricemia incidence analysis, those with baseline hyperuricemia (N = 3,194) were further excluded, yielding 13,846 eligible participants. During a median follow-up period of up to 7 years, 3,756 incident cases of MASLD and 3,294 incident cases of hyperuricemia were
Key inclusion criteria (3 listed)
- Underwent comprehensive health examinations at the Physical Examination Center of the First Affiliated Hospital of Ningbo University between 2017 and 2024;
- Aged 18 years or older at baseline;
- Completed an abdominal ultrasound examination during the health check-up.
Key exclusion criteria (4 listed)
- Underweight status at baseline, defined as BMI < 18.5 kg/m² ；
- Missing data on height, weight, or components of the metabolic syndrome ;
- Baseline diagnosis of MASLD or any other liver diseases
- Baseline diagnosis of hyperuricemia
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
Incidence of MASLD and Hyperuricemia
Time frame: 7 years
through study completion
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 3 Jun 2025.
- Derived from this study: PubMed 41310554Liu Y, Qian T, Zheng Y, Liu A, Xu L, Ye G, Xie J. Metabolically healthy obesity increases the risks of MASLD and hyperuricemia: a cohort study with mediation analysis. BMC Endocr Disord. 2025 Nov 27;26(1):3. doi: 10.1186/s12902-025-02106-9.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Metabolic Dysfunction-Associated Steatotic Liver Disease and Metabolically Healthy Obesity, run by Ningbo No. 1 Hospital 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 3 inclusion and 4 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: enrolling by invitation, as of the sponsor's last update on 3 Jun 2025. 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?
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?
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?
Incidence of MASLD and Hyperuricemia (time frame: 7 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07001865, which also lists 1 linked publication.
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 3 Jun 2025.