Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
2400 participants
OBSERVATIONAL
1992-07-31
2005-09-30
Brief Summary
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Detailed Description
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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:
1. Is it feasible to distinguish type 1 from early-onset type 2 diabetes at diagnosis? Which demographic, clinical, and family characteristics are most useful?
2. 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:
1. Is change in the incidence of childhood diabetes occurring uniformly across all age-, sex- and ethnic strata?
2. 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:
1. 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?
2. 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?
Conditions
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Keywords
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Study Design
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CASE_ONLY
Interventions
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Disease Surveillance, Family Studies, Questionnaire Followup
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
17 Years
ALL
Yes
Sponsors
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University of Chicago
OTHER
Responsible Party
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Principal Investigators
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Rebecca B Lipton, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Chicago
Locations
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The University of Chicago, Biological Sciences Division, Pritzker School of Medicine
Chicago, Illinois, United States
Countries
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References
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Lipton RB, Drum M, Burnet D, Rich B, Cooper A, Baumann E, Hagopian W. Obesity at the onset of diabetes in an ethnically diverse population of children: what does it mean for epidemiologists and clinicians? Pediatrics. 2005 May;115(5):e553-60. doi: 10.1542/peds.2004-1448.
Grover V, Lipton RB, Sclove SL. Seasonality of month of birth among African American children with diabetes mellitus in the city of Chicago. J Pediatr Endocrinol Metab. 2004 Mar;17(3):289-96. doi: 10.1515/jpem.2004.17.3.289.
Lipton RB, Zierold KM, Drum ML, Klein-Gitelman M, Kohrman AF. Re-hospitalization after diagnosis of diabetes varies by gender and socioeconomic status in urban African-American and Latino young people. Pediatr Diabetes. 2002 Mar;3(1):16-22. doi: 10.1034/j.1399-5448.2002.30104.x.
Onyemere KU, Lipton RB. Parental history and early-onset type 2 diabetes in African Americans and Latinos in Chicago. J Pediatr. 2002 Dec;141(6):825-9. doi: 10.1067/mpd.2002.130261.
Lipton RB, Drum M, Li S, Choi H. Social environment and year of birth influence type 1 diabetes risk for African-American and Latino children. Diabetes Care. 1999 Jan;22(1):78-85. doi: 10.2337/diacare.22.1.78.
Other Identifiers
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IRB Protocol #s:
Identifier Type: -
Identifier Source: secondary_id
11348B;
Identifier Type: -
Identifier Source: secondary_id
11564B;
Identifier Type: -
Identifier Source: secondary_id
12323B
Identifier Type: -
Identifier Source: secondary_id