Glycemic Control, Brain Structure and Cognition in Youth With Type 1 Diabetes (T1DM) (LO5/HY5)
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First Received Date ICMJE | April 7, 2009 | ||||
Last Updated Date | November 2, 2011 | ||||
Start Date ICMJE | November 2008 | ||||
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Change History | Complete list of historical versions of study NCT00879203 on ClinicalTrials.gov Archive Site | ||||
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Original Other Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | Glycemic Control, Brain Structure and Cognition in Youth With Type 1 Diabetes (T1DM) | ||||
Official Title ICMJE | Glycemic Control, Brain Structure and Cognition in Youth With T1DM | ||||
Brief Summary | LO5 study: The investigators are inviting a new group of youth (ages 7-16) who have been recently diagnosed with type 1 diabetes and their non-diabetic siblings. These youth will complete cognitive tests and a MRI scan of the brain. This scan uses strong magnets to obtain pictures and does not involve any radiation or injections. The investigators will recruit patients within three months of their diagnosis date. The study entails 1 study visit that lasts 3.5 hours. Evening and weekend times are available. The investigators plan to enroll 135 participants. HY5 study: The investigators are inviting a cohort of youth and young adults (ages 9-21) with type 1 diabetes and their non-diabetic siblings for a follow-up to a study they have already completed. This group of people will complete several memory and thinking tests along with several MRI scans of their brain, just as they did at their previous visits. The investigators plan to enroll 150 participants. |
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Detailed Description | |||||
Study Type ICMJE | Observational | ||||
Study Design ICMJE | Observational Model: Case Control Time Perspective: Prospective |
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Biospecimen | |||||
Sampling Method | Non-Probability Sample | ||||
Study Population | LO5: Youth with type 1 diabetes (T1DM) between the ages of 7-16 who have been diagnosed within the previous 3 months. Non-diabetic siblings of the participants with T1DM aged 7-16 years old. HY5: Youth and young adults (ages 9-21) who have already completed an earlier study with the lab. |
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Publications * | Perantie DC, Koller JM, Weaver PM, Lugar HM, Black KJ, White NH, Hershey T. Prospectively determined impact of type 1 diabetes on brain volume during development. Diabetes. 2011 Nov;60(11):3006-14. Epub 2011 Sep 27. | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Recruiting | ||||
Estimated Enrollment ICMJE | 285 | ||||
Estimated Completion Date | November 2013 | ||||
Primary Completion Date | |||||
Eligibility Criteria ICMJE | LO5: Inclusion Criteria for Participants with Type 1 Diabetes:
Inclusion Criteria for Participants without Type 1 Diabetes:
Exclusion Criteria for Participants with Type 1 Diabetes:
Exclusion Criteria for Participants without Type 1 Diabetes:
HY5: Must have been a participant in our earlier study. |
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Gender | Both | ||||
Ages | 7 Years to 16 Years | ||||
Accepts Healthy Volunteers | Yes | ||||
Contacts ICMJE |
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Location Countries ICMJE | United States | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT00879203 | ||||
Other Study ID Numbers ICMJE | 07-1258, RO1-DK-064832-06 | ||||
Has Data Monitoring Committee | No | ||||
Responsible Party | Washington University School of Medicine | ||||
Study Sponsor ICMJE | Washington University School of Medicine | ||||
Collaborators ICMJE | National Institutes of Health (NIH) | ||||
Investigators ICMJE |
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Information Provided By | Washington University School of Medicine | ||||
Verification Date | November 2011 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |