Expired Study
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Chicago, Illinois 60637


Purpose:

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.


Study summary:

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: 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?


Criteria:

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


Study is Available At:


Original ID:

R01 DK44752


NCT ID:

NCT00204009


Secondary ID:

IRB Protocol #s:


Study Acronym:


Brief Title:

Chicago Childhood Diabetes Registry


Official Title:

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


Overall Status:

Completed


Study Phase:

N/A


Genders:

Both


Minimum Age:

N/A


Maximum Age:

17 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of Chicago


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Observational


Study Design:

Observational Model: Case-Only


Number of Arms:

0


Number of Groups:

1


Total Enrollment:

2400


Enrollment Type:

Actual


Overall Contact Information

Official Name:Rebecca B Lipton, PhD
Principal Investigator
University of Chicago

Study Dates

Start Date:July 1992
Completion Date:September 2005
Completion Type:Actual
Primary Completion Date:September 2005
Primary Completion Type:Actual
Verification Date:September 2013
Last Changed Date:September 4, 2013
First Received Date:September 13, 2005

Study Outcomes

There are no available Study Outcomes

Study Interventions

Intervention Type:Behavioral
Name:Disease Surveillance, Family Studies, Questionnair

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of Chicago

Samples and Retentions

Study Population: target all diagnosed with diabetes before age 18 AND resident of the City of Chicago at diagnosis
Sample Method:Non-Probability Sample

Study References

Reference Type:Results Reference
Citation: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.
PMID:10333907
Reference Type:Results Reference
Citation: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.
PMID:12461500
Reference Type:Results Reference
Citation: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.
PMID:15016170
Reference Type:Results Reference
Citation: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.
PMID:15112905
Reference Type:Results Reference
Citation: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.
PMID:15867020

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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