Neurocognitive Impact of Hypoglycemia in Type 1 Diabetes

Type 1 Diabetes Mellitis Clinical Trial

— HYPO  

Official title:

Neurocognitive Impact of Hypoglycemia in Type 1 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00916838
• Other study ID #: 02-1012 -201102446
• Secondary ID: R01DK064832
• Status: Completed
• Start date: January 2003
• Est. completion date: February 2017

Study information

• Verified date: June 2018
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 187
• Est. completion date: February 2017
• Est. primary completion date: March 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years to 16 Years

Eligibility

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)

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Hypoglycemia
• Type 1 Diabetes Mellitis

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Washington University School of Medicine	National Institutes of Health (NIH)

External Links

•   Link Dr. Hershey's Web Site