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Genetic risk score of type 1 diabetes mellitus for progression to insulin in diabetic patients Lack of predictive value: a multicenter nested case-control study

Genetic risk score of type 1 diabetes mellitus for progression to insulin in diabetic patients Lack of predictive value: a multicenter nested case-control study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500111947
Enrollment
Unknown
Registered
2025-11-07
Start date
2025-11-07
Completion date
Unknown
Last updated
2025-11-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Newly diagnosed diabetes

Interventions

Patients with diabetes who 'progress to insulin deficiency' and 'progress to severe insulin deficiency':None
Patients who have not progressed to insulin deficiency:None

Sponsors

The Second Xiangya Hospital of Central South University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
14 Years to 40 Years

Inclusion criteria

Inclusion criteria: Target group: new-onset diabetics; 1.Gender is not limited; 2.Age 14-40 years; 3. Diabetes diagnosis =11.1mmol/L (200mg/dL) or Fasting plasma glucose >=7.0mmol/L (126mg/dL) or Plasma glucose at OGTT/2 hours after meal >=11.1mmol/L (200mg/dL) or HbA1c >=6%. 6.5% of HbA1c; (2) If there are no symptoms of diabetes, the test will need to be repeated once on another day to make the diagnosis; 4.Patients with new-onset diabetes mellitus in whom the diagnosis of staging is considered clinically unclear.

Exclusion criteria

Exclusion criteria: 1.Patients who have been clearly diagnosed with T1DM; 2.Gestational diabetes mellitus, monogenic diabetes mellitus (neonatal diabetes mellitus MODY), pancreatic exocrine disease (cystic fibrosis disease), drug or chemical-induced diabetes mellitus; 3.Long-term use of hormones or immunosuppressive drugs treatment; 4.Pregnant or breastfeeding women; 5.The combination of other autoimmune diseases, malignant neoplasms, severe liver and kidney disease, Uremia; 6. Life expectancy of not more than 3 years; 7. Mental illness or other reasons that make it impossible to cooperate with the investigation; 8. Acute stage of diabetic ketoacidosis; 9. Serious infections, fever, trauma, major surgeries, and other stressful situations; 10. Exogenous insulin treatment should be excluded from the IAA test for more than one week; 11. Patients with lack of key clinical information; 12. Patients who are not considered by the researchers to be suitable for participation in the study. The researcher believes that it is not suitable to participate in the study.

Design outcomes

Primary

MeasureTime frame
Islet autoantibodies: GADA, IA-2A, IAA;T1D GRS Score;

Countries

China

Contacts

Public ContactYang Xiao

The Second Xiangya Hospital of Central South University

xiaoyang29@hotmail.com+86 13574848588

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026