Diabetes MellitusNCT01690481
The Effects of High and Low Blood Glucose Values on the Brain in Children With Type 1 Diabetes Mellitus
An observational study of Diabetes Mellitus, run by Stanford University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus
- How many people
- 43 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2006to Dec 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Children between ages 3 to 10 with and without type 1 diabetes mellitus
Who may be able to join
- To take part in the study, you or your child must meet the following inclusion criteria:
- 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.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University School of Medicine
Stanford, California, 94305
About this study
Official title: Neurocognitive and Neuroanatomical Studies in Young Children With Type 1 Diabetes Mellitus
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.
Read more
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.
Read the detailed description
BROCHURE:
Name of Study: Neuropsychological and Neuroanatomical Studies in Young Children Study Directors: Tandy Aye, MD; Bruce Buckingham, MD; Darrell Wilson, MD
About the Study: This study is being conducted to see if Type 1 diabetes mellitus has any affect on learning, behavior and development in young children. Fifty to 60 children between the ages of 3 to less than 10 years with Type 1 diabetes mellitus will have neuropsychological testing and a nonsedated MRI scan of the head performed. The study will compare the results from those with diabetes to a control group of 20-30 children between the ages of 3 to less than 10 years without Type 1 diabetes mellitus. The control subjects will have neuropsychological testing and a nonsedated MRI scan of the head performed as well. All subjects maybe asked to repeat the neuropsychological testing and nonsedated MRI scan of the head 24 months later. The children with Type 1 diabetes mellitus will not have any changes made to their current diabetes regimen. The children with Type 1 diabetes mellitus should continue to check blood glucose values as required by their doctors and bring their meter(s) for downloading to each visit. The child should also tell his/her doctor about the frequency of severe low and high blood glucose values to his/er doctor as routinely asked.
Participant Schedule:
- One visit for 3-4 hours at the Stanford Medical Center to complete neuropsychological testing and to become familiar with the MRI scanner.
- Subjects who need to become more familiar with the MRI scanning process will view a video tape at home.
- One visit for 1-2 hours at Stanford Medical Center to have the MRI scan of the head completed.
- Subjects may have the neuropsychological testing and MRI scan repeated 24 months from time of the initial testing and scan.
Inclusion Criteria:
To take part in the study, the child must meet the following inclusion criteria:
- 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.
Exclusion Criteria:
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).
Compensation: There will be no cost to the subjects to participate in this research study. Participants will be compensated for their time. If you are interested in participating in this study and you meet the inclusion criteria, please contact:
Kim Caswell, APRN, BC (650)-724-1201 Email: kcaswell@stanford.edu Tandy Aye, MD (650)-723-5791 Email: taye@stanford.edu
- Conditions
- Diabetes Mellitus
- Medical subject headings
- Diabetes Mellitus
What is being measured
The primary outcome is the main question the study is designed to answer.
MRI brain volumes
Measured: 3 years
Secondary outcomes (1)
Neuropsychological scores
FSIQ, Memory score, Verbal comprehension score
Measured: 3 yr
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2012 (estimated)
- Study startDec 2006
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- William E And Aenid R Weisgerber Foundation
- Responsible party
- Principal investigator, Tandy Aye, Stanford University
- Investigators
- Tandy Aye MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01690481
- Sponsor's protocol ID
- SU-09242009-4020
- Other IDs
- IRB# 7723
- Status last verified
- Apr 2016
- First submitted
- 6 Aug 2012
- Last updated
- 14 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurocognitive and Neuroanatomical Studies in Young Children With Type 1 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT01690481
- Acronym / sponsor ID
- SU-09242009-4020
- Conditions
- Diabetes Mellitus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- William E And Aenid R Weisgerber Foundation
- Study start
- Dec 2006
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 21 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
BROCHURE:
Name of Study: Neuropsychological and Neuroanatomical Studies in Young Children Study Directors: Tandy Aye, MD; Bruce Buckingham, MD; Darrell Wilson, MD
About the Study: This study is being conducted to see if Type 1 diabetes mellitus has any affect on learning, behavior and development in young children. Fifty to 60 children between the ages of 3 to less than 10 years with Type 1 diabetes mellitus will have neuropsychological testing and a nonsedated MRI scan of the head performed. The study will compare the results from those with diabetes to a control group of 20-30 children between the ages of 3 to less than 10 years without Type 1 diabetes mellitus. The control subjects will have neuropsychological testing and a nonsedated MRI scan of the head performed as well. All subjects maybe asked to repeat the neuropsychological testing and nonsedated MRI scan of the head 24 months later. The children with Type 1 diabetes mellitus will not have any changes made to their current diabetes regimen. The children with Type 1 diabetes mellitus should continue to check blood glucose values as required by their doctors and bring their meter(s) for downloading to each visit. The child should also tell his/her doctor about the frequency of severe low and high blood glucose values to his/er doctor as routinely asked.
Participant Schedule:
- One visit for 3-4 hours at the Stanford Medical Center to complete neuropsychological testing and to become familiar with the MRI scanner.
- Subjects who need to become more familiar with the MRI scanning process will view a video tape at home.
- One visit for 1-2 hours at Stanford Medical Center to have the MRI scan of the head completed.
- Subjects may have the neuropsychological testing and MRI scan repeated 24 months from time of the initial testing and scan.
Inclusion Criteria:
To take part in the study, the child must meet the following inclusion criteria:
- 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.
Exclusion Criteria:
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).
Compensation: There will be no cost to the subjects to participate in this research study. Participants will be compensated for their time. If you are interested in participating in this study and you meet the inclusion criteria, please contact:
Kim Caswell, APRN, BC (650)-724-1201 Email: kcaswell@stanford.edu Tandy Aye, MD (650)-723-5791 Email: taye@stanford.edu
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 3 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children between ages 3 to 10 with and without type 1 diabetes mellitus
Key inclusion criteria (4 listed)
- To take part in the study, you or your child must meet the following inclusion criteria:
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
MRI brain volumes
Time frame: 3 years
1 secondary outcome
Neuropsychological scores
Time frame: 3 yr
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tandy Aye MD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MRI brain volumes (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2016.