Genetics Of Autoimmunity In Type I Diabetes
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Blood Collection.
- Who it may be relevant to
- Registry conditions: Type1diabetes, Diabetes Mellitus, Type 1, Type1 Diabetes Mellitus, Diabetes Mellitus. Basic parameters: from 2 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
The purpose of this study is to gain more information about the step-by-step process that causes someone to develop type 1 diabetes. Scientists think that a person's own immune system, directed by genetic and environmental factors play a major role in its development. Participation involves a blood draw, a brief medical history questionnaire and measurements of height and weight. Some participants will be asked to return for annual follow-up visits for 10 years.
Detailed description
The goal of this project is to gain knowledge about the development of Type 1 diabetes (T1D), as T1D is one of the most common chronic diseases in children. There has been a rise in the number of cases diagnosed as well as a decrease in the age of diagnosis. This project aims to understand the disease progression as seen in the immune system and to define the genetic and environmental factors that affect inflammation and regulation, which could determine disease progression or nonprogression. Families that include a family member with T1D will be recruited, as well as unrelated, healthy controls as a comparison group.
Participants will have height and weight measured, complete a social \& medical history questionnaire, and have blood drawn for analysis for HLA haplotype (a genetic sequence related to type 1 diabetes susceptibility)diabetes, blood glucose, immune system response, complete blood count, and autoantibody measurements. Some family members may return for follow-up visits for up to 10 years.
Interventions
- Other Blood Collection
Blood will be collected via venipuncture and analyzed. Blood samples will be analyzed for HLA haplotype (a genetic sequence related to type 1 diabetes susceptibility), plasma-induced signature, diabetes autoantibodies, complete blood count with differential, and serum and plasma for storage. For family members with diabetes, blood will also be tested for A1c.
Primary outcome measures
- Onset of Type 1 diabetes [Time frame: Up to 10 years]
- Autoantibody Measurement [Time frame: Up to 10 years]
Eligibility criteria
Inclusion Criteria (Families):
- Families where at least one first-degree family member has type 1 diabetes
- The diabetic proband in the family was diagnosed before the age of 39
- Family members must be at least 2 years old to participate
Exclusion Criteria (Families):
- Families with no history of type 1 diabetes
- Families with a history of diabetes that is not type 1 (LADA, MODY, type 2 etc.)
Inclusion Criteria (Controls):
- No family history of type 1 diabetes or other autoimmune conditions
- Age 2 or older
Exclusion Criteria (Controls):
- Personal or family history of autoimmune disease
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Family-based
Study locations
United States · 1 center
- Medical College of Wisconsin — Milwaukee
Identifiers
NCT: NCT03648918 · 142618 · McGee Sibling Study