NCT07307040

Brief Summary

This project will leverage a large-scale cohort of early-onset type 2 diabetes patients to conduct innovative prospective clinical research. By integrating traditional Chinese medicine diagnostic information, clinical data, laboratory results, continuous glucose monitoring, genetic information, multi-omics data, and multi-modal monitoring data, and utilizing advanced data analysis methods such as deep learning, the project aims to establish a comprehensive monitoring, precise classification, and personalized diagnosis and treatment model-a holistic management approach integrating traditional Chinese and Western medicine for early-onset type 2 diabetes. This initiative is expected to enhance the management of early-onset type 2 diabetes, improve treatment outcomes and quality of life for affected patients, pioneer an innovative path for personalized integrated traditional Chinese and Western medicine management in this population, and promote the application of precision medicine in diabetes prevention and treatment.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
11mo left

Started Dec 2025

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress28%
Dec 2025Mar 2027

First Submitted

Initial submission to the registry

December 1, 2025

Completed
28 days until next milestone

First Posted

Study publicly available on registry

December 29, 2025

Completed
2 days until next milestone

Study Start

First participant enrolled

December 31, 2025

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2027

Last Updated

December 29, 2025

Status Verified

December 1, 2025

Enrollment Period

1.2 years

First QC Date

December 1, 2025

Last Update Submit

December 14, 2025

Conditions

Keywords

Integrated Traditional Chinese and Western MedicinePrecision ManagementPersonalized ManagementEarly-Onset Type 2 Diabetes

Outcome Measures

Primary Outcomes (2)

  • Traditional Chinese Medicine Syndrome Score

    Through study completion, an average of 3 months

  • HbA1c

    Through study completion, an average of 3 months

Secondary Outcomes (5)

  • Triglycerides

    Through study completion, an average of 3 months

  • High-Density Lipoprotein Cholesterol

    Through study completion, an average of 3 months

  • Total Cholesterol

    Through study completion, an average of 3 months

  • Fasting Blood Glucose

    Through study completion, an average of 3 months

  • Low-Density Lipoprotein Cholesterol

    Through study completion, an average of 3 months

Study Arms (1)

Integrated Traditional Chinese and Western Medicine Management

Other: No interventions

Interventions

No interventions

Integrated Traditional Chinese and Western Medicine Management

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

The age at type 2 diabetes diagnosis is ≥18 years but \<40 years.

You may qualify if:

  • The age at diabetes diagnosis is ≥18 years but \<40 years.

You may not qualify if:

  • The clinical diagnosis was type 1 diabetes, and at the time of enrollment, antibody levels or insulin/C-peptide results still supported the original diagnosis.
  • There were clear secondary factors contributing to hyperglycemia, such as Cushing's syndrome or pheochromocytoma.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief physician

Study Record Dates

First Submitted

December 1, 2025

First Posted

December 29, 2025

Study Start

December 31, 2025

Primary Completion (Estimated)

March 31, 2027

Study Completion (Estimated)

March 31, 2027

Last Updated

December 29, 2025

Record last verified: 2025-12