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Recruiting NCT07492004

China Monogenic Diabetes Registry

Observational Neonatal Diabetes Monogenic Diabetes Maturity Onset Diabetes of the Young

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: No Interventions.
Who it may be relevant to
Registry conditions: Neonatal Diabetes, Monogenic Diabetes, Maturity Onset Diabetes of the Young. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

This observational study aims to establish a digital registry, screening platform for patients with monogenic diabetes using internet-based and mobile application technologies. The primary objectives are to: Characterize the genetic landscape of monogenic diabetes in the Chinese population, including pathogenic variants and their distribution Participants will: * Enroll in the monogenic diabetes registry via mobile application or web-based platform * Undergo molecular genetic testing to establish a definitive diagnosis

Detailed description

This study will include the subjects of a series of studies on monogenic diabetes conducted by our team, including neonatal diabetes, maturity-onset diabetes of the young, maternally inherited diabetes and deafness, and other monogenic diabetes caused by different causative genes, and establish a large sample database and specimen bank through follow-up and omics analysis.

Interventions

  • Other No Interventions
    No Interventions

Primary outcome measures

  • Screened and confirmed monogenic diabetes [Time frame: 6 months]

Eligibility criteria

Inclusion criteria

  • Diabetes diagnosed before 25 years of age; OR diabetes diagnosed before 35 years of age with ≥1 first-degree relative (parent, sibling, or offspring) diagnosed with diabetes before 40 years of age
  • Body mass index (BMI) at diagnosis 28 kg/m²
  • Negative glutamic acid decarboxylase antibody (GAD-Ab)

Exclusion criteria

  • Secondary diabetes
  • Active malignancy or history of malignant tumor within the past 5 years

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 1 center
  • Tianjin medical university general hospital — Tianjin

Identifiers

NCT: NCT07492004 · IRB2022-YX-164-02

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗