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Completed

NCT Number: NCT00204009

Chicago Childhood Diabetes Registry

The goal of this study is to investigate the epidemiology and natural history of childhood-onset diabetes, whether of autoimmune, non-autoimmune, or mixed etiology in affected probands and their relatives.

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Key information

Age range

Up to 17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The University of Chicago, Biological Sciences Division, Pritzker School of Medicine

Chicago, Illinois, 60637, United States

About this study

The goal of this study is to investigate the epidemiology and natural history of childhood-onset diabetes, whether of autoimmune, non-autoimmune, or mixed etiology in affected probands and their relatives. The following hypotheses frame the research questions to be addressed:

Hypothesis 1. Diabetes as it occurs in youth derives from a spectrum of etiologic processes, from the insulinopenia of autoimmune type 1 to obesity-related, insulin-resistant type 2 diabetes. A subset of children develop diabetes through a combination of the 2 major etiologic pathways, with autoimmune ß-cell destruction aggravated by the presence of insulin resistance related to genetic susceptibility, obesity and/or physical inactivity. A fraction of young patients are unclassifiable at onset due to severe symptomatology and ambiguities in measures of ß-cell function. This poses the research challenge of misclassification of disease, as well as the clinical difficulty of potentially inappropriate treatment … Since patients are drawn from the city-wide registry, clustering of genetic and behavioral risk factors will be systematically identified without the selection bias inherent in case series and clinic-based studies.

Research questions:

  • Is it feasible to distinguish type 1 from early-onset type 2 diabetes at diagnosis? Which demographic, clinical, and family characteristics are most useful?
  • Is the risk of developing diabetes among siblings of early-onset type 2 or mixed cases equivalent to that for siblings of type 1 patients? Which characteristics are most predictive of risk? Hypothesis 2. Changes in the epidemiologic parameters of childhood diabetes over the past 2 decades are directly related to changes in the prevalence of risk factors for both type 1 and type 2 diabetes, including obesity, physical inactivity, and perinatal exposures.

Research questions:

  • Is change in the incidence of childhood diabetes occurring uniformly across all age-, sex- and ethnic strata?
  • Are secular changes in type 2 incidence rates continuing, and is this occurring in all age-, sex- and ethnic strata? Hypothesis 3. A complex interplay of heritable, behavioral, and treatment factors can accelerate or delay the development of chronic diabetes complications. It is particularly compelling to understand this process in young patients, those with the most years of productive life at risk. … Recent observations indicate that features of the metabolic syndrome, over and above glycemic control, are potent risk factors for macrovascular complications. Familial aggregation of these traits may itself play a role in determining the risk of chronic complications among young people with diabetes.

Research questions:

  • Do young people with diabetes who demonstrate signs and symptoms of early complications have greater insulin resistance or other characteristics that distinguish them from those patients who are free of complications, controlled for disease duration and metabolic control?
  • Do young patients with early signs/symptoms of complications have more parents who themselves have elevated cardiovascular disease risk factors, than patients who are free of chronic complications, controlled for disease duration and metabolic control?

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • diagnosed with diabetes before age 18 AND resident of the City of Chicago at diagnosis

Exclusion criteria

  • diabetes secondary to another condition, e.g. cystic fibrosis

Treatment and study plan

Disease Surveillance, Family Studies, Questionnaire Followup

Behavioral

Sponsors and collaborators

Lead sponsor

University of Chicago

Other

Registry information

Official study title

Population-based Epidemiologic Study of Childhood Diabetes in Chicago: a) Disease Surveillance; b) Family Studies; c) Questionnaire Followup.

Important dates

Study start
1992
Primary completion
2005
Study completion
2005
First posted
Sep 20, 2005
Registry last updated
Sep 5, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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