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Neurocognitive Impact of Hypoglycemia in Type 1 Diabetes (HYPO)

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ClinicalTrials.gov Identifier: NCT00916838
Recruitment Status : Completed
First Posted : June 10, 2009
Last Update Posted : June 18, 2018
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Washington University School of Medicine

Tracking Information
First Submitted Date June 2, 2009
First Posted Date June 10, 2009
Last Update Posted Date June 18, 2018
Study Start Date January 2003
Actual Primary Completion Date March 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History Complete list of historical versions of study NCT00916838 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Neurocognitive Impact of Hypoglycemia in Type 1 Diabetes
Official Title Neurocognitive Impact of Hypoglycemia in Type 1 Diabetes
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 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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population 125 children with Type 1 Diabetes Mellitus (T1DM) between 4 and 16 were recruited from the Diabetes Clinic at St. Louis Children's Hospital. 62 healthy siblings between 4 and 16 also enrolled in the study.
Condition Type 1 Diabetes Mellitis
Intervention Not Provided
Study Groups/Cohorts
  • 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: June¬†9,¬†2009)
187
Original Actual Enrollment Same as current
Actual Study Completion Date February 2017
Actual Primary Completion Date March 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria

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)
Sex/Gender
Sexes Eligible for Study: All
Ages 4 Years to 16 Years   (Child)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries United States
 
Administrative Information
NCT Number NCT00916838
Other Study ID Numbers 02-1012 -201102446
R01DK064832 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Washington University School of Medicine
Study Sponsor Washington University School of Medicine
Collaborators National Institutes of Health (NIH)
Investigators
Principal Investigator: Tamara G Hershey, PhD. Washington Univeristy School of Medicine
PRS Account Washington University School of Medicine
Verification Date June 2018