HLA Demographics Study in Adults With Type 1 Diabetes

NCT06860516 | Recruiting

• 1 other identifier: GNTI-T1D-HLA-1002
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 5

Brief Summary

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

Conditions

Diabetes Mellitus, Type I

Outcome Measures

Primary Outcomes (1)

• HLA DRB1*04:01 positive

  to evaluate the frequency of adults with recently diagnosed type 1 diabetes that are HLA DRB1\*04:01 positive at time of enrollment

  Day 1

Secondary Outcomes (1)

• HLA-DRB1*04:01 genotype by ethnic and racial subgroups

  Day 1

Study Arms (1)

all participants

aged ≥ 18 to ≤ 55 years recently (within 6 months of the study visit) diagnosed with T1D

Other: blood draw or cheek swab

Interventions

blood draw or cheek swab OTHER

a blood draw or cheek swab for testing of HLA-DRB1\*04:01

all participants

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

This study will enroll up to approximately 200 adults aged ≥ 18 to ≤ 55 years with recently (within 6 months of the study visit) diagnosed T1D who have met the American Diabetes Association T1D diagnosis criteria.

You may qualify if:

• Male and female participants aged ≥ 18 to ≤ 55 years, with type 1 DM meeting American Diabetes Association criteria at diagnosis:
• Fasting glucose ≥ 126 mg/dL (7.0 mmol/L), or
• hour oral glucose tolerance test plasma glucose ≥ 200 mg/dL (11.0 mmol/L), or
• Hemoglobin A1c ≥ 6.5%, or
• Random plasma glucose ≥ 200 mg/dL (11.1 mmol/L) (with documented classic hyperglycemia symptoms or hyperglycemic crisis).
• Date of T1D diagnosis within 6 months of the study visit.
• 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.

You may not qualify if:

• 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.
• Participant is unwilling or unable to comply with the study visit assessments.

Sponsors & Collaborators

• GentiBio, Inc: lead

Study Sites (5)

University of California, San Francisco

San Francisco, California, 94158, United States

RECRUITING

University of Florida- Gainesville

Gainesville, Florida, 32610, United States

RECRUITING

Joslin Diabetes Center

Boston, Massachusetts, 02215, United States

RECRUITING

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

RECRUITING

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27514, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

a single blood draw or cheek swab for the analysis of HLA genotype of the study participants

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Mark Bach, MD

  GentiBio, Inc

  STUDY DIRECTOR

Central Study Contacts

Kristin M Neff, MS

CONTACT

85-732-75483; kristin.neff@gentibio.com

Mark Bach, MD

CONTACT

908-578-3634; mark.bach@gentibio.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2025
• First Posted: March 6, 2025
• Study Start: June 6, 2025
• Primary Completion (Estimated): January 30, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: May 6, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: within 6 months from study completion

Locations

US (5)