Type 2 Diabetes Mellitus (T2DM)NCT06984510
Accelerated Biological Aging is Associated With Increased Risk of T2DM in the MASLD Population
An observational study of Type 2 Diabetes Mellitus (T2DM) and Metabolic Dysfunction-Associated Steatotic Liver Disease, run by Ningbo No. 1 Hospital at 1 site in China.
Trial summary
The association between biological aging and type 2 diabetes mellitus (T2DM) incidence in individuals with and without metabolic dysfunction-associated steatotic liver disease (MASLD) remains unclear.We assessed biological age by calculating phenotypic age (PhenoAge), Klemera-Doubal method (KDMAge), and homeostatic… Read more about this study
- Who is it for?
- Ages 20 to 90 years
- Conditions the study is for
- Type 2 Diabetes Mellitus (T2DM), Metabolic Dysfunction-Associated Steatotic Liver Disease, Biological Age
- What is being tested?
- Observational
- How many people
- 2,720 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 20 to 90 years
- All sexes
- Adult, Older adult
Study population: This retrospective cohort study is based on physical examination at the Physical Examination Center of The First Affiliated Hospital of Ningbo University and included participants aged 20 to 90 years. Individuals included had available abdominal ultrasound data and at least one recorded metabolic indicator per year. Participants with type 2 diabetes at baseline or with other causes of hepatic steatosis were excluded. The study population was categorized into MASLD and non-MASLD groups for comparative analysis.
Who may be able to join
- Abdominal ultrasound data available in annual health check-up records
- At least one of the following five metabolic indicators recorded annually:
- Body mass index (BMI) or waist circumference (2) Blood pressure (3) Serum triglycerides (4) High-density lipoprotein cholesterol (HDL-C) (5) Fasting plasma glucose or glycated hemoglobin (HbA1c)
Who cannot join
- Age <20 or >90 years
- Other causes of hepatic steatosis (e.g., alcoholic liver disease or hepatitis B infection)
- Type 2 diabetes mellitus at baseline
- Missing baseline data for any of the following variables: systolic blood pressure, albumin, alkaline phosphatase, blood urea nitrogen, creatinine, glycated hemoglobin (HbA1c), total cholesterol, lymphocyte percentage, white blood cell count, mean corpuscular volume, uric acid, fasting plasma glucose, and red cell distribution width (RDW)
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, 1 recruiting
- Recruiting
the First Affiliated Hospital of Ningbo University Ningbo, Zhejiang, China, 315000
Ningbo, Zhejiang, 315000
Lei Xu, MD, +8613486659126, xulei22@163.com
About this study
Official title: Accelerated Biological Aging is Associated With Increased Risk of T2DM in the MASLD Population: a Cohort Study
The association between biological aging and type 2 diabetes mellitus (T2DM) incidence in individuals with and without metabolic dysfunction-associated steatotic liver disease (MASLD) remains unclear.We assessed biological age by calculating phenotypic age (PhenoAge), Klemera-Doubal method (KDMAge), and homeostatic dysregulation (HDAge). To examine the association of biological ageing with the risk of T2DM, cox regression models were conducted. Furthermore, we applied survival analysis, restricted cubic spline models and population attributable fraction (PAF) to further evaluate the association between biological ageing and T2DM incidence.
- Conditions
- Type 2 Diabetes Mellitus (T2DM), Metabolic Dysfunction-Associated Steatotic Liver Disease, Biological Age
- Being tested
- Observational
- 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.
ObservationalOther
Observational
| Study group | Role | What they receive |
|---|---|---|
| MASLD group | participants with MASLD at baseline Receives: Other: Observational | |
| non-MASLD group | participants without MASLD at baseline Receives: Other: Observational |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of onset T2DM
Measured: through study completion, an average of 3 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 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.
- Other trials for Type 2 Diabetes Mellitus (T2DM)Studies 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
- 2,720 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
- NCT06984510
- Sponsor's protocol ID
- 2025-070RS-01
- Other IDs
- MR-33-25-026098
- Status last verified
- May 2025
- First submitted
- 11 May 2025
- Last updated
- 4 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accelerated Biological Aging is Associated With Increased Risk of T2DM in the MASLD Population: a Cohort Study
- ClinicalTrials.gov ID
- NCT06984510
- Acronym / sponsor ID
- 2025-070RS-01
- Conditions
- Type 2 Diabetes Mellitus (T2DM), Metabolic Dysfunction-Associated Steatotic Liver Disease, Biological Age
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,720 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
- 22 May 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.
The association between biological aging and type 2 diabetes mellitus (T2DM) incidence in individuals with and without metabolic dysfunction-associated steatotic liver disease (MASLD) remains unclear.We assessed biological age by calculating phenotypic age (PhenoAge), Klemera-Doubal method (KDMAge), and homeostatic dysregulation (HDAge). To examine the association of biological ageing with the risk of T2DM, cox regression models were conducted. Furthermore, we applied survival analysis, restricted cubic spline models and population attributable fraction (PAF) to further evaluate the association between biological ageing and T2DM incidence.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MASLD group | – | Other: Observationalparticipants with MASLD at baseline |
| non-MASLD group | – | Other: Observationalparticipants without MASLD at baseline |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- This retrospective cohort study is based on physical examination at the Physical Examination Center of The First Affiliated Hospital of Ningbo University and included participants aged 20 to 90 years. Individuals included had available abdominal ultrasound data and at least one recorded metabolic indicator per year. Participants with type 2 diabetes at baseline or with other causes of hepatic steatosis were excluded. The study population was categorized into MASLD and non-MASLD groups for comparative analysis.
Key inclusion criteria (3 listed)
- Abdominal ultrasound data available in annual health check-up records
- At least one of the following five metabolic indicators recorded annually:
- Body mass index (BMI) or waist circumference (2) Blood pressure (3) Serum triglycerides (4) High-density lipoprotein cholesterol (HDL-C) (5) Fasting plasma glucose or glycated hemoglobin (HbA1c)
Key exclusion criteria (4 listed)
- Age <20 or >90 years
- Other causes of hepatic steatosis (e.g., alcoholic liver disease or hepatitis B infection)
- Type 2 diabetes mellitus at baseline
- Missing baseline data for any of the following variables: systolic blood pressure, albumin, alkaline phosphatase, blood urea nitrogen, creatinine, glycated hemoglobin (HbA1c), total cholesterol, lymphocyte percentage, white blood cell count, mean corpuscular volume, uric acid, fasting plasma glucose, and red cell distribution width (RDW)
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 |
|---|---|---|
| ObservationalObservational | Other | MASLD group, non-MASLD group |
Primary outcome
Incidence of onset T2DM
Time frame: through study completion, an average of 3 year
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 4 Jun 2025.
- 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.
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 Type 2 Diabetes Mellitus (T2DM) and Metabolic Dysfunction-Associated Steatotic Liver Disease, 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: looking for participants now, as of the sponsor's last update on 4 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?
Contact Lei Xu (+8613486659126, xulei22@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of onset T2DM (time frame: through study completion, an average of 3 year). 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 4 Jun 2025.