Clinical trial Recruiting at 1 site Observational

Chinese monogenic diabetes registry

Official title: China Monogenic Diabetes Registry

Run by Tianjin Medical University General Hospital · NCT07492004 · Data updated 2026-11-12

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 typeObservational
SexAll
Enrollment5000 (estimated)
SponsorTianjin Medical University General Hospital
Academic / other
Locations1 site (Tianjin)
StatusRecruiting
StartedFebruary 28, 2021
Main results expectedJuly 31, 2030
Study endsJuly 31, 2030
Registry record updatedMarch 25, 2026
Trial IDNCT07492004 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably 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.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: 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.

Who can join: the full rules

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 it's running

  • Tianjin medical university general hospital
    Tianjin, China
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

  • Identifying Monogenic Diabetes Misdiagnosed as Type 1

    This study is trying to find out how often young people are wrongly diagnosed with type 1 diabetes when they actually have a rare form called monogenic diabetes, by testing their blood and looking for specific genetic changes.

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  • Liraglutide for people with maturity-onset diabetes of the young (MODY)

    This trial will try liraglutide in people with genetically confirmed MODY to see if it improves blood sugar, body weight, and gastrointestinal symptoms.

    Recruiting Phase 2 Children's Hospital Medical Center, Cincinnati · Cincinnati, Ohio · NCT07029009

  • Dorzagliatin for glucokinase (GCK-MODY) diabetes

    This trial will test whether dorzagliatin, a drug that activates glucokinase, can lower blood sugar in adults with GCK-MODY caused by an inactivating GCK mutation.

    Recruiting Phase 2 Chinese University of Hong Kong · Hong Kong · NCT06976658

  • Personalized management for monogenic diabetes using genetic screening

    This study is testing a new online platform that helps people with monogenic diabetes by using genetic screening to create personalized treatment plans for better blood sugar control.

    Recruiting Tianjin Medical University General Hospital · Tianjin · NCT06746610

  • Understanding beta cell disorders through genetic insights

    This study is trying to learn more about beta cell problems, like diabetes, by looking at the genes of people with and without these issues to see if it can help find new treatments.

    Recruiting University of Exeter · Exeter, Devon · NCT06478121

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.