China Monogenic Diabetes Registry (CMDR)

Tianjin Medical University

Status: Enrolling

Conditions: Neonatal Diabetes; Maturity Onset Diabetes of the Young; Monogenic Diabetes

Treatments: Other: No Interventions

Study type: Observational

Funder types: Other

Identifiers

NCT07492004

IRB2022-YX-164-02

Details and patient eligibility

About

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

Full 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.

Enrollment: 5,000 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 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
2. Body mass index (BMI) at diagnosis 28 kg/m²
3. Negative glutamic acid decarboxylase antibody (GAD-Ab)

Exclusion criteria

1. Secondary diabetes
2. Active malignancy or history of malignant tumor within the past 5 years

Trial design

5,000 participants in 1 patient group

Monogenic Diabetes

Treatment:

Other: No Interventions