Neurocognitive Impact of Hypoglycemia in Type 1 Diabetes

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.

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Key information

Conditions

Type 1 Diabetes Mellitis

Age range

4 year–16 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

National Institutes of Health (NIH)

Registry information

Acronym: HYPO

Important dates

Study start: 2003
Primary completion: 2006
Study completion: 2017
First posted: Jun 10, 2009
Registry last updated: Jun 18, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed