Clinical trial NCT03648918: Genetics Of Autoimmunity In Type I Diabetes
Official title: Genetics Of Autoimmunity In Type I Diabetes
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Type1diabetes
Diabetes Mellitus, Type 1
Type1 Diabetes Mellitus
Diabetes Mellitus
Keywords: Family
Healthy Controls
Siblings
Lead sponsor: Medical College of Wisconsin
Sponsor class: OTHER
Collaborators: name: Benaroya Research Institute
name: Indiana University
First posted: 2018-08-28
Enrollment: 4000
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: FAMILY_BASED
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with T1D seen at clinics at the Children's Wisconsin (n\~1500) and Froedtert Hospital (n\~800) will be targeted. In families with a child proband, siblings will be asked to join the study. If the diabetic child has an aunt, uncle, or cousin with T1D, then siblings in that nuclear family will also be recruited. Adult proband families will include the adult affected by T1D and their children. Adult proband families must include children \<17 years of age. If the adult proband has a sibling, niece, or nephew with T1D, siblings in that nuclear family will be recruited as well. The age-of-diagnosis criterion for the proband will be less than 39 years and insulin therapy started within 5 years of diagnosis.

Brief summary: 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.

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

Primary outcomes:
measure: Onset of Type 1 diabetes
timeFrame: Up to 10 years
measure: Autoantibody Measurement
timeFrame: Up to 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
Study officials:
affiliation: Medical College of Wisconsin
name: Martin Hessner, PhD
role: PRINCIPAL_INVESTIGATOR
References: