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Neurocognitive Impact of Hypoglycemia in Type 1 Diabetes (HYPO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00916838
Recruitment Status : Active, not recruiting
First Posted : June 10, 2009
Last Update Posted : May 10, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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.


Condition or disease
Type 1 Diabetes Mellitis

Study Design

Study Type : Observational
Actual Enrollment : 187 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Neurocognitive Impact of Hypoglycemia in Type 1 Diabetes
Study Start Date : January 2003
Primary Completion Date : March 2006
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort
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.


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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)
Contacts and Locations

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): NCT00916838


Sponsors and Collaborators
Washington University School of Medicine
National Institutes of Health (NIH)
Investigators
Principal Investigator: Tamara G Hershey, PhD. Washington Univeristy School of Medicine
More Information

Additional Information:
Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00916838     History of Changes
Other Study ID Numbers: 02-1012
R01DK064832 ( U.S. NIH Grant/Contract )
First Posted: June 10, 2009    Key Record Dates
Last Update Posted: May 10, 2017
Last Verified: May 2017

Keywords provided by Washington University School of Medicine:
Type 1 Diabetes Mellitis
MRI

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Hypoglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases