Search for a Cause of Diabetes

Etiology and Epidemiology of Type 1 Diabetes

Protocol Description

Now entering its 37th year, this groundbreaking, long-term study explores the causes of type 1 diabetes, with the overall objective of prediction and prevention of the disease. Through this study, researchers analyze the relationships between influential factors, such as viral infections, genetics and environment; obesity and related insulin resistance; and the importance of activation of white blood cells and various diabetes-related autoantibodies and what causes them to appear. The study includes children with new onset diabetes and their first-degree relatives. It has continuously screened family members for diabetes-related immune factors, which can result in early intervention to help in the treatment of diabetes. Family members with high-risk antibodies may be eligible for ongoing trials aimed to prevent this disease.

Eligibility Criteria

Participants include patients age 1 and up, who have Type 1 diabetes, as well as their family members.
Males: Age 1 and older
Females: Age 1 and older

Requirements

An interview, body measurements and a blood sample will be collected from participating patients and family members during initial screening and every 6 months.
Visits: 2 times a year
Duration: Blood sampling for 2 years for participating children with diabetes and 10 years for family members with continuous contact to inquire about diabetes development

Status: Closed to Enrollment

Source(s) of Support

National Institutes of Health
National Institute of Diabetes and Digestive and Kidney Diseases
Cochrane Weber Fund
Renziehausen Fund

Additional Information

Sample Repository and Sharing 

We have stored samples of sera, plasma and frozen peripheral blood mononuclear cells over the 37 years of our study “Etiology and Epidemiology of Insulin Dependent Diabetes” (PI Dr. Dorothy Becker) from children with insulin-requiring diabetes and their first degree relatives. Data sets are available to be distributed under a data sharing policy. For example, these must be limited to records without personal identifiers or any other variables that might enable individual participants to be identified. These data are only provided to investigators under a data sharing agreement who agree in advance to adhere to established policies for protecting the privacy and confidentiality of enrolled subjects.

We encourage researchers around the country to take advantage of this repository to investigate hypotheses based on newly developed assays to further our knowledge and understanding of the pathogenesis and progression of type 1 diabetes mellitus and its prodrome. Examples of such current data sharing include a grant awarded to Dr. M. Pietropaolo – “Enhancement of Biomarkers for Type 1 Diabetes” (RO1 DK53456-09). We have also identified samples to be included in a current JDRF supported collaboration with Dr. K. Gillespie, Bristol, UK, PI – of a 4 center study (SNAIL) including 3 other cohorts (Box, Babydiab & Daisy).

Proposed studies will be evaluated by an already established Children’s Hospital of Pittsburgh of UPMC Diabetes Scientific Committee (composed of Director of Pediatric Endocrinology and Diabetes, Chair of the Children’s Hospital of Pittsburgh Advisory Committee as well as “ad hoc” experts in the field) with careful consideration of the scientific value, feasibility and sample availability. The committee provides a letter indicating conditional approval for access to data and/or samples in order to obtain appropriate funding to complete the study. Ancillary studies are considered collaborative, and recipients of data and samples are expected to work together with the investigators to analyze and publish their results. Material Transfer Agreements between institutions are required for data and sample sharing.

Primary Investigator

Dorothy Becker, MBBCh
Ingrid Libman MD, PhD

Contact Information

Dorothy Becker, MBBCh 
dorothy.becker@chp.edu   
 412-692-5179 

Ingrid Libman, MD, PhD
ingrid.libman@chp.edu    
412-692-3274