Status:
COMPLETED
Glycemic Control, Brain Structure and Cognition in Youth With Type 1 Diabetes (T1DM)
Lead Sponsor:
Washington University School of Medicine
Collaborating Sponsors:
National Institutes of Health (NIH)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Type 1 Diabetes Mellitis
Cognition
Eligibility:
All Genders
7-16 years
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 te...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
November 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 1 2016
Estimated Enrollment :
230 Patients enrolled
Trial Details
Trial ID
NCT00879203
Start Date
November 1 2008
End Date
October 1 2016
Last Update
November 2 2016
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Washington University School of Medicine
St Louis, Missouri, United States, 63110