TrialNet Natural History Study
|Principal Investigator: CarolFoster|
|Keywords: Type 1 Diabetes , T1D Risk , T1D Familial Risk , Type 1 Diabetes Autoantibodies||Department: Pediatric Administration|
|IRB Number: 00013287||Co Investigator: MaryMurray|
|Specialty: Endocrinology and Metabolism, Endocrinology and Metabolism, Pediatric Endocrinology and Metabolism|
|Sub Specialties: Diabetes, Type 1 Diabetes and Intensive Insulin Therapy,|
The overall objective of this study is to perform baseline and repeat assessments over time of the metabolic and immunologic status of individuals at risk for type 1 diabetes (T1D).
· To characterize their risk for developing T1D
· To describe the pathogenetic evolution of T1D and
· To increase the understanding of the pathogenetic factors involved in the development of T1D
The primary study outcome is T1D as defined by the American Diabetes Association (ADA).
Non-diabetic blood relatives of individuals with T1D (proband) aged 1-45 years (first degree: siblings, offspring, parents); aged 1-20 years (second or third degree: nieces, nephews, aunts uncles, grandchildren, cousins, half-siblings). Definition of T1D in the proband requires onset of diabetes before age 40 years and prescription of insulin therapy within one year of diagnosis.
Participants must not have previous or current use of insulin (former participants in the Diabetes Prevention Trial are exempt from this exclusion criterium) or oral hypoglycemic agents, immunosuppressive or immunomodulary therapies, have diabetes by 1997 ADA criteria, known severe active diseases and/or diseases which are likely to limit life expectancy or lead to use of immunosuppressive or immunomodulatory therapies during the course of the study.