HLA Demographics Study in Adults With Type 1 Diabetes

ConditionDiabetes Mellitus, Type I

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18-55

SponsorGentiBio, Inc

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Fasting glucose ≥ 126 mg/dL (7.0 mmol/L), or

2-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).

Disqualifiers

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.

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

blood draw or cheek swab
Other intervention
a blood draw or cheek swab for testing of HLA-DRB1\*04:01 and other HLA alleles

Treatment groups

200 Participants

are divided into 1 treatment group

Group A: all participants1 intervention

Trial outcomes

Primary outcomes

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

Time frame

Day 1

Secondary outcomes

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

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

Time frame

Day 1

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

GentiBio, Inc

Lead sponsor

Source ClinicalTrials.gov

Apply now