Study on Compositional and Functional Difference of T cell receptor and B cell receptor among Type 1 Diabetes and high-risk population

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR2400086499

Enrollment

Unknown

Registered

2024-07-03

Start date

2024-07-03

Completion date

Unknown

Last updated

2024-07-08

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

Conditions

Diabetes Mellitus

Interventions

LADA group:N/A

T1D group:N/A

T2D group:N/A

Healthy control group:N/A

Eligibility

Sex/Gender

All

Age

18 Years to 70 Years

Inclusion criteria

Inclusion criteria: LADA inclusion criteria: ? In line with the WHO diabetes diagnosis and treatment standards in 1999 ? Age: 18-70 years old, age at diagnosis of diabetes = 18 years old; ? At least half a year after the diagnosis of diabetes, they did not rely on insulin; ? Positive for islet autoantibodies (glutamic acid decarboxylase antibody (GADA), protein tyrosine phosphatase 2 autoantibody (IA-2A), insulin autoantibody (IAA), tetracycline 7 (TSPAN7), zinc transporter 8 autoantibody (ZnT8A)) or positive islet autoantigen specific T cells ? Sign informed consent form T1DM inclusion criteria: ? In line with the WHO diabetes diagnosis and treatment standards in 1999 ? Age 18-70 years old ? Positive for pancreatic islet autoantibodies (GADA, IA-2A, IAA, TSPAN7, ZnT8A) ? Sign informed consent form T2DM inclusion criteria: ? In line with the WHO diabetes diagnosis and treatment standards in 1999 ? Age 18-70 years old ? Sign informed consent form

Exclusion criteria

Exclusion criteria: ? Suffering from other autoimmune diseases ? Currently pregnant or breastfeeding ? Blood cell count, liver enzymes (ALT>2 times normal) and abnormal coagulation function, moderate to severe renal dysfunction (blood creatinine>2mg/dL or 177mmol/L) ? Current or previous HIV, hepatitis B and hepatitis C infection ? Laboratory or clinical evidence suggests the presence of severe infection ? Suffering from mental illness or cognitive impairment ? Participated in clinical trials within 6 weeks that may affect disease or immune status ? Other factors that may affect the experiment

Design outcomes

Primary

Measure	Time frame
TCR and BCR;	—

Secondary

Measure	Time frame
glycosylated hemoglobin(HbA1c);Glycated albumin;Fasting blood glucose;insulin;C-peptide;	—

Countries

China

Contacts

Public ContactJia Weiping

Shanghai Sixth People's Hospital

wpjia@sjtu.edu.cn+86 172 7520 8312

Outcome results

None listed

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