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Glycemic Control, Brain Structure and Cognition in Youth With Type 1 Diabetes (T1DM) (LO5/HY5)

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ClinicalTrials.gov Identifier: NCT00879203
Recruitment Status : Completed
First Posted : April 9, 2009
Last Update Posted : November 2, 2016
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Washington University School of Medicine

Study Description
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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.


Condition or disease
Type 1 Diabetes Mellitis Cognition

Study Design
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Study Type : Observational
Actual Enrollment : 230 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Glycemic Control, Brain Structure and Cognition in Youth With T1DM
Study Start Date : November 2008
Actual Primary Completion Date : November 2013
Actual Study Completion Date : October 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Groups and Cohorts
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Group/Cohort
Type 1 Diabetes (T1DM)
Youth and young adults with T1DM
Non diabetic siblings
Non diabetic, young siblings of T1DM participants


Outcome Measures
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Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   7 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Criteria

LO5:

Inclusion Criteria for Participants with Type 1 Diabetes:

  • Between the ages of 7 and 16
  • Diagnosed with type 1 diabetes within 3 months

Inclusion Criteria for Participants without Type 1 Diabetes:

  • Between the ages of 7 and 16

Exclusion Criteria for Participants with Type 1 Diabetes:

  • Pregnant or lactating
  • Chronic disease other than T1DM, well-controlled asthma, or Hashimoto's thyroiditis
  • Other current serious medical illness
  • Psychiatric illness
  • Psychoactive drug dependence
  • Neurological illness (except T1DM-related): stroke, seizure, major loss of consciousness, head injuries, encephalitis, or hydrocephalus, blindness, deafness
  • Use of psychoactive medications or exposure to neuroleptics (except that exposures of less than 1 month, occurring more than 5 years ago, will be allowed)
  • Use of dopamine depleting agents or stimulants such as Ritalin, Cylert, Adderall
  • Pre-maturity at birth of more than 4 wks early with complications (e.g. on respirator at NICU)
  • Inability to complete MRI scan (e.g. claustrophobia, metal implants)
  • Full set (top and bottom) of orthodontic braces (Half set braces, fillings, and retainers are OK)

Exclusion Criteria for Participants without Type 1 Diabetes:

  • Same as above (except cannot have type 1 diabetes)

HY5: Must have been a participant in our earlier study.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00879203


Locations
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United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
National Institutes of Health (NIH)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
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Principal Investigator: Tamara G. Hershey, PhD Washington University School of Medicine
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00879203    
Other Study ID Numbers: 07-1258
R01DK064832-06 ( U.S. NIH Grant/Contract )
First Posted: April 9, 2009    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: October 2016
Keywords provided by Washington University School of Medicine:
Type 1 Diabetes Mellitis
Youth
Hypoglycemia
Hyperglycemia
 Cognition
Memory
Brain Growth & Development
Magnetic Resonance Imaging
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 1
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
 Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases