The Effects of High and Low Blood Glucose Values on the Brain in Children With Type 1 Diabetes Mellitus

NCT01690481 | Completed

• 2 other identifiers: SU-09242009-4020IRB# 7723
• Study Type: observational
• Target: 43
• Locations: 1 country
• Sites: 1

Brief Summary

Simplified Brochure Neuropsychological Testing/Assessment is like games for the child. They are asked to complete the sequence, identify pictures, explain what is happening, etc. There is no personality testing involved. Part of the standard IQ testing is done but no IQ score is obtained. Age appropriate testing is done for each child. The MRI is an enclosed machine. We have the child sit in a simulator after the neuropsychological testing to see what it will be like, including the sounds, etc. You will be given a video about MRI testing to view as well. The staff that does this has been doing this for years in a wide variety of children, young, developmental delayed, etc. The staff does this WITHOUT sedation. Some children cannot sit still through the entire series. We need to get six, 10 minute scans. Children are allowed movement such as the need to wiggle their toes and move in between each scan. The Neuropsychological Testing can be scheduled in the late afternoons if it is more convenient for your family. This visit may take 3-4 hours. The MRI scanning can be scheduled after 5pm and may take up to 2 hours depending on the child's cooperation. You maybe asked to repeat the Neuropsychological Testing and MRI scanning 24 months later.

Conditions

Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• MRI brain volumes

  3 years

Secondary Outcomes (1)

• Neuropsychological scores

  3 yr

Eligibility Criteria

• Age: 3 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children between ages 3 to 10 with and without type 1 diabetes mellitus

You may qualify if:

• Be between the ages of 3 to 10 years.
• Have been diagnosed with type 1 diabetes for at least 6 months.
• Do not have plans to move out of the area within the next 36 months.

You may not qualify if:

• If the interested participant has a history of:
• head trauma with any loss of consciousness,
• cystic fibrosis,
• prematurity (born less than 30 weeks of gestation),
• significant developmental delay (lack of single word speech or ability to walk independently by 18 months of age),
• neurologic disease independent of diabetes (eg seizure disorder or medical contraindication to MRI procedure (eg metal appliances such as braces)

Sponsors & Collaborators

• Stanford University: lead
• William E And Aenid R Weisgerber Foundation: collaborator

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Tandy Aye MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 6, 2012
• First Posted: September 21, 2012
• Study Start: December 1, 2006
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: April 14, 2016

Record last verified: 2016-04

Locations

US (1)