A Non-interventional Study of HLA-DRB1*04:01 Distribution in Adults With Recently Diagnosed Type 1 Diabetes (T1D)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 10
- 主要终点
- HLA DRB1*04:01 positive
研究概览
简要总结
This is a study to evaluate the HLA-DRB1*04:01 genotype in adults that have been diagnosed with type 1 diabetes
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •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).
- •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.
排除标准
- •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.
研究组 & 干预措施
all participants
aged ≥ 18 to ≤ 55 years recently (within 6 months of the study visit) diagnosed with T1D
干预措施: blood draw or cheek swab (Other)
结局指标
主要结局
HLA DRB1*04:01 positive
时间窗: 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
次要结局
- HLA-DRB1*04:01 genotype by ethnic and racial subgroups(Day 1)