NCT06860516

HLA Demographics Study in Adults With Type 1 Diabetes

A Non-interventional Study of HLA-DRB1*04:01 Distribution in Adults With Recently Diagnosed Type 1 Diabetes (T1D)

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 50 (estimated)
• Sponsor: GentiBio, Inc · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

This is a study to evaluate the HLA-DRB1\*04:01 genotype in adults that have been diagnosed with type 1 diabetes

Detailed description

This is a non-interventional study to evaluate the distribution of human leukocyte antigen (HLA)-DRB1\*04:01 genotype in participants that are recently (within 2 months of the study visit) diagnosed with T1D, with a single blood draw for the analysis of HLA genotype within the study participants. The study duration will be 24 hours and will include a single study visit for the collection of demographic data and a single blood draw, and a follow-up telephone call 24 hours after the study visit.

Conditions

• Diabetes Mellitus, Type I

Interventions

Type	Name	Description
OTHER	blood draw	a blood draw for testing of HLA-DRB1\*04:01

Timeline

• Start date: 2025-06-06
• Primary completion: 2026-01-30
• Completion: 2026-06-01
• First posted: 2025-03-06
• Last updated: 2025-09-18

Locations

5 sites across 1 country: United States