Status:
COMPLETED
Neurocognitive Impact of Hypoglycemia in Type 1 Diabetes
Lead Sponsor:
Washington University School of Medicine
Collaborating Sponsors:
National Institutes of Health (NIH)
Conditions:
Type 1 Diabetes Mellitis
Eligibility:
All Genders
4-16 years
Brief Summary
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 assesse...
Eligibility Criteria
Inclusion
- Age 4 - 16 (for MRI, must be 7 or older)
Exclusion
- 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)
Key Trial Info
Start Date :
January 1 2003
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 1 2017
Estimated Enrollment :
187 Patients enrolled
Trial Details
Trial ID
NCT00916838
Start Date
January 1 2003
End Date
February 1 2017
Last Update
June 18 2018
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.