Diabetes Mellitus, Type I
Conditions
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 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.
Interventions
OTHERblood draw or cheek swab
a blood draw or cheek swab for testing of HLA-DRB1\*04:01 and other HLA alleles
Sponsors
GentiBio, Inc
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
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.
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HLA DRB1*04:01 positive | Day 1 | to evaluate the frequency of adults with recently diagnosed type 1 diabetes that are HLA DRB1\*04:01 positive at time of enrollment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| HLA-DRB1*04:01 genotype by ethnic and racial subgroups | Day 1 | to determine the distribution of HLA-DRB1\*04:01 genotype in adults recently diagnosed with type 1 diabetes at the time of enrollment by ethnic and racial subgroups |
Countries
United States
Contacts
CONTACTKristin M Neff, MS
CONTACTMark Bach, MD
STUDY_DIRECTORMark Bach, MD
GentiBio, Inc
Outcome results
None listed