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RecruitingNCT06984510Updated Jun 4, 2025

Accelerated Biological Aging is Associated With Increased Risk of T2DM in the MASLD Population

An observational study in Type 2 Diabetes Mellitus (T2DM), Metabolic Dysfunction-Associated Steatotic Liver Disease and Biological Age, sponsored by Ningbo No. 1 Hospital. Recruiting at 1 site in China. Open to participants aged 20 Years to 90 Years. Per ClinicalTrials.gov, last updated 2025-06-04.

Sponsored by Ningbo No. 1 Hospital · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2025, 10 months ago, but the record still lists the study as recruiting.
  • Started Apr 2025; still recruiting 1 year 7 months later.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
2,720
Ages
20 Years to 90 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Type 2 Diabetes Mellitus (T2DM)
  • Metabolic Dysfunction-Associated Steatotic Liver Disease
  • Biological Age
03

In context

Diabetes Mellitus, Type 2

10,371 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,406 are open to participants now.

This study's planned enrollment of 2,720 is above the median of 300 across 1,741 observational studies indexed under Diabetes Mellitus, Type 2.

Browse Diabetes Mellitus, Type 2 studies →

Lead sponsor

Ningbo No. 1 Hospital is the lead sponsor of 59 studies on the registry; 12 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 90 Years
Sexes eligible
All
Sampling method
Non-probability sample

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Abdominal ultrasound data available in annual health check-up records
  2. At least one of the following five metabolic indicators recorded annually:

(1) (BMI) or waist circumference (2) Blood pressure (3) Serum triglycerides (4) High-density lipoprotein cholesterol (HDL-C) (5) Fasting plasma glucose or (HbA1c)

Exclusion criteria

Exclusion Criteria:

  1. Age \<20 or >90 years
  2. Other causes of hepatic steatosis (e.g., alcoholic liver disease or infection)
  3. Type 2 diabetes mellitus at baseline
  4. Missing baseline data for any of the following variables: systolic blood pressure, albumin, alkaline phosphatase, blood urea nitrogen, creatinine, (HbA1c), total cholesterol, lymphocyte percentage, white blood cell count, mean corpuscular volume, uric acid, fasting plasma glucose, and red cell distribution width (RDW)
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

HbA1c

A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
2,720 participants (estimated)
Patient registry
No

Groups and cohorts

  • MASLD group

    participants with MASLD at baseline

    Other: Observational

  • non-MASLD group

    participants without MASLD at baseline

    Other: Observational

Interventions

  • OtherObservational

    Observational

06

What researchers measure

Primary outcomes

  1. Incidence of onset T2DM

    Time frame: through study completion, an average of 3 year

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 4, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06984510
Lead sponsor
Ningbo No. 1 Hospital
Responsible party
Sponsor
First posted
May 22, 2025
Start date
Apr 1, 2025
Primary completion
Dec 31, 2025 (estimated)
Completion
Dec 31, 2025 (estimated)
Last update
Jun 4, 2025

Study contacts

Lei Xu
Contact
xulei22@163.com
+8613486659126

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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