Neurocognitive Impact of Hypoglycemia in Type 1 Diabetes (HYPO)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by Washington University School of Medicine.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT00916838
First received: June 2, 2009
Last updated: June 7, 2012
Last verified: June 2012
  Purpose

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
Type 1 Diabetes Mellitis

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Neurocognitive Impact of Hypoglycemia in Type 1 Diabetes

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

Enrollment: 187
Study Start Date: January 2003
Estimated Study Completion Date: December 2013
Primary Completion Date: March 2006 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   4 Years to 16 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00916838

Sponsors and Collaborators
Washington University School of Medicine
Investigators
Principal Investigator: Tamara G Hershey, PhD. Washington Univeristy School of Medicine
  More Information

Additional Information:
No publications provided

Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00916838     History of Changes
Other Study ID Numbers: 02-1012, RO1-DK64832
Study First Received: June 2, 2009
Last Updated: June 7, 2012
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on August 19, 2014