Genetics Of Autoimmunity In Type I Diabetes

Diabetes Mellitus Clinical Trial

Official title:

Genetics Of Autoimmunity In Type I Diabetes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03648918
• Other study ID #: 142618
• Secondary ID: McGee Sibling St
• Status: Recruiting
• Start date: August 2001
• Est. completion date: January 2050

Study information

• Verified date: October 2023
• Source: Medical College of Wisconsin
• Contact: Martin Hessner, PhD
• Phone: 414-955-4903
• Email: t1dinfo[@]mcw.edu
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 4000
• Est. completion date: January 2050
• Est. primary completion date: January 2050
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type1 Diabetes Mellitus
• Type1diabetes

Intervention

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.

Locations

Country	Name	City	State
United States	Medical College of Wisconsin	Milwaukee	Wisconsin

Sponsors (3)

Lead Sponsor	Collaborator
Medical College of Wisconsin	Benaroya Research Institute, Indiana University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Onset of Type 1 diabetes	The primary outcome is the development of diabetes as defined by the American Diabetes Association (ADA) based on the presence of symptoms and unequivocal hyperglycemia.	Up to 10 years
Primary	Autoantibody Measurement	Presence or absence of the autoantibodies related to type 1 diabetes: IA-2 (islet antigen), GAD65 (pancreatic islet cell autoantibody), IAA (insulin autoantibody), ZnT8 (zinc transporter 8)	Up to 10 years