Accelerated Biological Aging is Associated With Increased... | NCT06984510

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

NCT06984510

Sponsor

Ningbo No. 1 Hospital

Status

Recruiting

Last Update Posted

Jun 4, 2025Actual

Enrollment

2,720Estimated

Phase

Not provided

Conditions

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

Interventions

Observational

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
MR-33-25-026098	Registry Identifier	medicalresearch.cn

Status Module

Record Verification Date

May 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 1, 2025Actual

Primary Completion Date

Dec 31, 2025Estimated

Completion Date

Dec 31, 2025Estimated

First Submitted Date

May 11, 2025

First Submission Date that Met QC Criteria

May 21, 2025

First Posted Date

May 22, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 30, 2025

Last Update Posted Date

Jun 4, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

2,720Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
MASLD group		participants with MASLD at baseline	Other: Observational
non-MASLD group		participants without MASLD at baseline	Other: Observational

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Observational	Other	Observational	MASLD group non-MASLD group

Measure	Description	Time Frame
Incidence of onset T2DM		through study completion, an average of 3 year

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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)

Exclusion Criteria:

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)

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

90 Years

Standard Ages

AdultOlder 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.

Sampling Method

Non-Probability Sample

Name	Role	Phone	Extension	Email
Lei Xu	Contact	+8613486659126		xulei22@163.com

Facility	Status	City	State	ZIP	Country	Contacts
the First Affiliated Hospital of Ningbo University Ningbo, Zhejiang, China, 315000	Recruiting	Ningbo	Zhejiang	315000	China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D003924	Diabetes Mellitus, Type 2

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Intervention Browse Module

MeSH Terms

ID	Term
D057832	Watchful Waiting

Ancestor Terms

ID	Term
D017063	Outcome Assessment, Health Care
D010043	Outcome and Process Assessment, Health Care
D011787	Quality of Health Care
D006298	Health Services Administration

Browse Leaves

Not provided

Browse Branches

Not provided