A Study of the Genetic Causes of Latent Autoimmune Diabetes in Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 205
- 试验地点
- 2
- 主要终点
- Identify variations in the human genome associated with LADA by genotyping cases and comparing allele frequencies to an existing control database
研究概览
简要总结
This is a prospective study that will study adults and has the objective of examining 'Latent Autoimmune Diabetes in Adults' (LADA) to understand how this trait is influenced by genetic factors.
详细描述
A case-control study approach will be used to compare the allelic frequencies of Deoxyribonucleic acid (DNA) markers of the cases (i.e., LADA patients) to a randomly selected control samples that does not have the trait under study. To study the role of genetic factors in LADA, the study seeks to determine if certain genomic regions that are captured or mirrored by selective Single nucleotide polymorphisms (SNPs) that are genotyped, are over or underrepresented in those with the disease compared to those who do not. The level of auto-antibodies is the serum can also be studied as a quantitative trait where we ask the question if there is correlation with specific SNP alleles that are genotyped. The markers that are found to be over or under-represented in the study cases will then be tested in an independent set of patients also recruited in this study. This allows us to filter markers that show significance simply by chance and prevents us from being misled.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 25 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed type 2 Diabetes (T2D) patient with: BMI <30 at diagnosis; Age >25-<50 at diagnosis
- •Diagnosed type 1 Diabetes (T1D) patient with: Age >25 at diagnosis
- •Currently Diagnosed with LADA with age at initial diagnosis of Diabetes >25 years and a positive GAD65 antibody test
排除标准
- •Any underlying disease or condition that is a contraindication for obtaining 18.0 ml of blood.
- •Inability to obtain an informed consent from a given LADA case.
- •Blood sampling has already occurred for a given subject.
- •Previous GAD65 antibody test(s) negative.
结局指标
主要结局
Identify variations in the human genome associated with LADA by genotyping cases and comparing allele frequencies to an existing control database
时间窗: 5 years
次要结局
- Identify associations between genetic variants with certain measurable risk profiles that can be used to judge the health status or well being of a LADA case.(5 years)