Diabetes MellitusNCT00204009
Chicago Childhood Diabetes Registry
An observational study of Diabetes Mellitus, run by University of Chicago at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Disease Surveillance, Family Studies, Questionnaire Followup
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 2,400 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 1992to Sep 2005
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: target all diagnosed with diabetes before age 18 AND resident of the City of Chicago at diagnosis
Who may be able to join
- diagnosed with diabetes before age 18 AND resident of the City of Chicago at diagnosis
Who cannot join
- diabetes secondary to another condition, e.g. cystic fibrosis
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Chicago, Biological Sciences Division, Pritzker School of Medicine
Chicago, Illinois, 60637
About this study
Official title: Population-based Epidemiologic Study of Childhood Diabetes in Chicago: a) Disease Surveillance; b) Family Studies; c) Questionnaire Followup.
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.
Read the detailed description
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?
- Conditions
- Diabetes Mellitus
- Being tested
- Disease Surveillance, Family Studies, Questionnaire Followup
- Keywords
- children and adolescents, epidemiology
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Disease Surveillance, Family Studies, Questionnaire FollowupBehavioural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startJul 1992
- Primary completionSep 2005
- Study completionSep 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Enrolment
- 2,400 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rebecca B Lipton, PhD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00204009
- Sponsor's protocol ID
- R01DK044752
- Other IDs
- IRB Protocol #s:, 11348B;, 11564B;, 12323B
- Status last verified
- Sep 2013
- First submitted
- 13 Sep 2005
- Last updated
- 5 Sep 2013
- Results posted
- No
Publications
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.
PubMed 15867020Grover 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.
PubMed 15112905Lipton 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.
PubMed 15016170Onyemere 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.
PubMed 12461500Lipton 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.
PubMed 10333907
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Population-based Epidemiologic Study of Childhood Diabetes in Chicago: a) Disease Surveillance; b) Family Studies; c) Questionnaire Followup.
- ClinicalTrials.gov ID
- NCT00204009
- Acronym / sponsor ID
- R01DK044752
- Conditions
- Diabetes Mellitus
- Keywords
- children and adolescents, epidemiology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,400 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- Jul 1992
- Primary completion
- Sep 2005 (actual)
- Study completion
- Sep 2005 (actual)
- First posted
- 20 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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?
Study design
- Observational model
- Case only
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- target all diagnosed with diabetes before age 18 AND resident of the City of Chicago at diagnosis
Key inclusion criteria (1 listed)
- diagnosed with diabetes before age 18 AND resident of the City of Chicago at diagnosis
Key exclusion criteria (1 listed)
- diabetes secondary to another condition, e.g. cystic fibrosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Disease Surveillance, Family Studies, Questionnaire Followup | Behavioural | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2013.
- Results publication: PubMed 15867020Lipton 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.
- Results publication: PubMed 15112905Grover 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.
- Results publication: PubMed 15016170Lipton 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.
- Results publication: PubMed 12461500Onyemere 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.
- Results publication: PubMed 10333907Lipton 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rebecca B Lipton, PhD principal investigator
University of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, run by University of Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00204009, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2013.