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

NCT06984510 | Recruiting

• 2 other identifiers: 2025-070RS-01MR-33-25-026098
• Study Type: observational
• Target: 2,720
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Incidence of onset T2DM

  through study completion, an average of 3 year

Study Arms (2)

MASLD group

participants with MASLD at baseline

Other: Observational

non-MASLD group

participants without MASLD at baseline

Other: Observational

Interventions

Observational OTHER

Observational

MASLD group; non-MASLD group

Eligibility Criteria

• Age: 20 Years - 90 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Ningbo No. 1 Hospital: lead

Study Sites (1)

the First Affiliated Hospital of Ningbo University Ningbo, Zhejiang, China, 315000

Ningbo, Zhejiang, 315000, China

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration

Central Study Contacts

Lei Xu

CONTACT

+8613486659126; xulei22@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2025
• First Posted: May 22, 2025
• Study Start: April 1, 2025
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: June 4, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)