Neurocognitive Impact of Hypoglycemia in Type 1 Diabetes (HYPO)

June 15, 2018 updated by: Washington University School of Medicine

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

187

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 16 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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.

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Washington University School of Medicine

Collaborators

National Institutes of Health (NIH)

Investigators

  • Principal Investigator: Tamara G Hershey, PhD., Washington Univeristy School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2003

Primary Completion (Actual)

March 1, 2006

Study Completion (Actual)

February 1, 2017

Study Registration Dates

First Submitted

June 2, 2009

First Submitted That Met QC Criteria

June 9, 2009

First Posted (Estimate)

June 10, 2009

Study Record Updates

Last Update Posted (Actual)

June 18, 2018

Last Update Submitted That Met QC Criteria

June 15, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 02-1012 -201102446
  • R01DK064832 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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