Chinese monogenic diabetes registry
China Monogenic Diabetes Registry
This project will test whether an online and mobile registry can find and genetically confirm people in China with monogenic forms of diabetes, including neonatal diabetes and MODY.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 5000 (estimated) |
| Sex | All |
| Sponsor | Tianjin Medical University General Hospital Academic / other |
| Locations | 1 site (Tianjin) |
| Trial ID | NCT07492004 on ClinicalTrials.gov |
What this trial studies
Participants enroll through a mobile app or web platform and provide clinical information and consent for molecular genetic testing. The study performs targeted genetic sequencing and broader omics analyses on collected samples to characterize pathogenic variants and their distribution in the Chinese population. Data and specimens are stored in a centralized database and biobank to support follow-up, family screening, and future research. The registry aggregates subjects from related monogenic diabetes cohorts (neonatal diabetes, MODY, maternally inherited diabetes and deafness) to build a large sample set.
Who should consider this trial
Good fit: Ideal candidates are people diagnosed with diabetes before age 25, or before age 35 with at least one first‑degree relative diagnosed before 40, who were relatively lean at diagnosis (BMI ≤28 kg/m²) and are GAD‑antibody negative.
Not a fit: People with secondary diabetes, active malignancy or a history of cancer within the past five years, or those with typical late‑onset obesity‑related type 2 diabetes are unlikely to benefit from this registry.
Why it matters
Potential benefit: If successful, the registry could help more people obtain a genetic diagnosis that enables personalized treatment decisions and family screening.
How similar studies have performed: Similar national and regional monogenic diabetes registries and genetic screening programs have successfully identified pathogenic variants and changed patient management, so this approach has precedent.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Tianjin
- Tianjin medical university general hospital — Tianjin, China (Recruiting)
Study contacts
- Study coordinator: Ming Liu
- Email: mingliu@tmu.edu.cn
- Phone: +86 022-27813550
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.