Neurocognitive Impact of Hypoglycemia in Type 1 Diabetes

NCT00916838 | Completed

• 2 other identifiers: 02-1012 -201102446R01DK064832
• Study Type: observational
• Target: 187
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Type 1 Diabetes Mellitis

Keywords

Type 1 Diabetes Mellitis; MRI

Study Arms (2)

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.

Eligibility Criteria

• Age: 4 Years - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• Age 4 - 16 (for MRI, must be 7 or older)

You may not qualify if:

• 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 & Collaborators

• Washington University School of Medicine: lead
• National Institutes of Health (NIH): collaborator

Study Officials

• Tamara G Hershey, PhD.

  Washington Univeristy School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2009
• First Posted: June 10, 2009
• Study Start: January 1, 2003
• Primary Completion: March 1, 2006
• Study Completion: February 1, 2017
• Last Updated: June 18, 2018

Record last verified: 2018-06