- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00916838
Neurocognitive Impact of Hypoglycemia in Type 1 Diabetes (HYPO)
125 children with Type 1 Diabetes mellitis (T1DM) between 4 and 16 were recruited and 62 healthy siblings also enrolled in the study.
Children with T1DM and sibling controls ages 4 to 16 were assessed on memory and executive control skills at entry to the study (Test 1) and after two years of close monitoring for blood sugar events (Test 2). Diabetic children have their blood sugar tested directly before and after cognitive testing to ensure their blood sugar is within range during the testing. The 2-year follow-up period involves parents/child reporting any severe diabetic episode and periodically providing the results of the diabetic child's usual blood tests from their glucose monitoring device.
Children 7 and older also underwent high resolution MRI scans.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age 4 - 16 (for MRI, must be 7 or older)
Exclusion Criteria:
- Pregnant or lactating (females 13+)
- Chronic disease other than T1DM, well-controlled asthma, or Hashimoto's thyroiditis. (Exclude for hypothyroidism)
- Other current serious medical illness
- Co-morbid psychiatric illness: such as mania, ADHD, LD, major depression, mental retardation, or psychoactive drug dependence
- Co-morbid neurological illness: stroke, seizure, major loss of consciousness, other brain trauma/surgery, or head injuries (i.e. near drowning), encephalitis, or hydrocephalus, blindness, deafness
- EXCEPT T1DM-related
- Pre-maturity at birth >4 wks early (<36 wk term) w/ sequelae e.g. on respirator at NICU
- 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) or pts. w/recent tx w/dopamine depleting agents or stimulants such as Ritalin, Cylert, Adderall
- Contraindication to MRI scan (e.g. claustrophobia, metal implants, foreign bodies) - N/A if < 4 years old
- Full set (top and bottom) orthodontic braces. (Half set braces, fillings, and retainers are OK)
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Type 1 Diabetes Mellitis
Children with Type 1 Diabetes Mellitis (T1DM) between 4 and 16 were recruited.
|
Non diabetic Control
62 healthy siblings also enrolled in the study between the ages of 4 and 17.
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Tamara G Hershey, PhD., Washington Univeristy School of Medicine
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 02-1012 -201102446
- R01DK064832 (U.S. NIH Grant/Contract)
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