Clinical trial NCT06860516: HLA Demographics Study in Adults With Type 1 Diabetes
Official title: A Non-interventional Study of HLA-DRB1*04:01 Distribution in Adults With Recently Diagnosed Type 1 Diabetes (T1D)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Diabetes Mellitus, Type I
Lead sponsor: GentiBio, Inc
Sponsor class: INDUSTRY
First posted: 2025-03-06
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: This study will enroll up to 50 adults aged ≥ 18 to ≤ 45 years with recently (within 2 months of the study visit) diagnosed T1D who have met the American Diabetes Association T1D diagnosis criteria.

Brief 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.

Eligibility criteria: Inclusion Criteria:

1. Male and female participants aged ≥ 18 to ≤ 45 years, with type 1 DM meeting American Diabetes Association criteria at diagnosis:

   1. Fasting glucose ≥ 126 mg/dL (7.0 mmol/L), or
   2. 2-hour oral glucose tolerance test plasma glucose ≥ 200 mg/dL (11.0 mmol/L), or
   3. Hemoglobin A1c ≥ 6.5%, or
   4. Random plasma glucose ≥ 200 mg/dL (11.1 mmol/L) (with documented classic hyperglycemia symptoms or hyperglycemic crisis).
2. Date of T1D diagnosis within 2 months of the study visit.
3. Able and willing to provide written, informed consent as approved by the institutional review board (IRB). Participants must be able to consent directly; no other person or guardian may consent for them in this study.

Exclusion Criteria:

1. Participant is an employee of, or an immediate family member of an employee, of the Sponsor, study site, or of a contractor/vendor who is involved in direct study conduct for this protocol.
2. Participant is unwilling or unable to comply with the study visit assessments.

Primary outcomes:
measure: HLA DRB1*04:01 positive
timeFrame: Day 1
Secondary outcomes:
measure: HLA-DRB1*04:01 genotype by ethnic and racial subgroups
timeFrame: Day 1
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
city: Gainesville
country: United States
facility: University of Florida- Gainesville
state: Florida
city: Boston
country: United States
facility: Joslin Diabetes Center
state: Massachusetts
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
Study officials:
affiliation: GentiBio, Inc
name: Mark Bach, MD
role: STUDY_DIRECTOR
References: