HLA Demographics Study in Adults With Type 1 Diabetes

a study on Diabetes Diabetes Type 1

Summary

Eligibility
for people ages 18-55 (full criteria)
Location
at UCSF
Dates
study started
study ends around
Principal Investigator
by Stephen Gitelman, MD (ucsf)
Headshot of Stephen Gitelman
Stephen Gitelman

Description

Summary

This is a study to evaluate the HLA-DRB1*04:01 genotype in adults that have been diagnosed 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)

Details

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 6 months of the study visit) diagnosed with T1D, with a single blood draw for the analysis of HLA genotype within the study participants. Some participants may elect to collect buccal cells via cheek swabs for genotype analysis. The study duration will be approximately 24 hours and will include a single study visit for the collection of demographic data and a single blood draw or cheek swab, and a follow-up telephone call approximately 24 hours after the study visit.

Keywords

Diabetes Mellitus, Type I, Type 1 Diabetes Mellitus, Blood Specimen Collection, blood draw or cheek swab

Eligibility

You can join if…

Open to people ages 18-55

  1. Male and female participants aged ≥ 18 to ≤ 55 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 6 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.

You CAN'T join if...

  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.

Locations

  • University of California, San Francisco accepting new patients
    San Francisco California 94158 United States
  • University of Florida- Gainesville accepting new patients
    Gainesville Florida 32610 United States

Lead Scientist at University of California Health

  • Stephen Gitelman, MD (ucsf)
    Dr. Gitelman is a physician scientist involved in studies to determine what causes type 1 diabetes mellitus (T1DM), and in clinical trials to prevent disease development, or preserve beta cell function in those recently diagnosed. To this end, he has been an active investigator in the NIH-sponsored TrialNet and Immune Tolerance Network consortia, and other immunotherapy trials in T1DM.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
GentiBio, Inc
ID
NCT06860516
Study Type
Observational
Participants
Expecting 200 study participants
Last Updated
Contact us about this trial