Neuropsychological and Neuroanatomical Studies of Young Children With and Without Type 1 Diabetes Mellitus

An observational study of Type 1 Diabetes Mellitus, run by Stanford University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This study is being conducted to see if Type 1 diabetes mellitus has any affect on learning, behavior and development in young children and whether there are associated changes on their MRI scan. Read more about this study

Who is it for?: Ages 3 to 10 yearsHealthy volunteers can take part
Conditions the study is for: Type 1 Diabetes Mellitus
How many people: 30 participants
Where: 1 siteUnited States
Study dates: Jan 2007to Mar 2016
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: please see inclusion and exclusion criteria

Who may be able to join

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

Who cannot join

No 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
Stanford, California, 94305

Other trials in United States

About this study

This study is being conducted to see if Type 1 diabetes mellitus has any affect on learning, behavior and development in young children and whether there are associated changes on their MRI scan.

Read the detailed description

In this pilot study approximately 10-20 children between the ages of 3 to 10 years with Type 1 diabetes mellitus will have neuropsychological testing and a nonsedated MRI scan of the head performed every three years for three years. We will compare this to a control group of 10 children between the ages of 3 adn 10 years without Type 1 diabetes mellitus. The control subjects will neuropsychological testing and a nonsedated MRI scan of the head once. The children with Type 1 diabetes mellitus will not have any changes made to their current diabetes regimen.

Conditions: Type 1 Diabetes Mellitus
Keywords: Type 1 diabetes mellitus
Medical subject headings: Diabetes Mellitus, Type 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2007Mar 2016

First posted21 Mar 2007 (estimated)
Study startJan 2007
Primary completionMar 2016
Study completionMar 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Type 1 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
Time perspective: Cross-sectional
Enrolment: 30 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00449891
Sponsor's protocol ID: IRB 97517
Other IDs: 1102002-100-GHATW
Status last verified: Apr 2016
First submitted: 19 Mar 2007
Last updated: 14 Apr 2016
Results posted: No
Data monitoring committee: Yes

Publications

Aye T, Barnea-Goraly N, Ambler C, Hoang S, Schleifer K, Park Y, Drobny J, Wilson DM, Reiss AL, Buckingham BA. White matter structural differences in young children with type 1 diabetes: a diffusion tensor imaging study. Diabetes Care. 2012 Nov;35(11):2167-73. doi: 10.2337/dc12-0017. Epub 2012 Sep 10.
PubMed 22966090

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Type 1 Diabetes Mellitus trials

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: Neuropsychological and Neuroanatomical Studies of Young Children With and Without Type 1 Diabetes Mellitus
ClinicalTrials.gov ID: NCT00449891
Acronym / sponsor ID: IRB 97517
Conditions: Type 1 Diabetes Mellitus
Keywords: Type 1 diabetes mellitus
Study type: Observational
Recruitment status: Completed
Enrolment: 30 participants (estimated)
Lead sponsor: Stanford UniversityUniversity, hospital or other
Collaborators: William E And Aenid R Weisgerber Foundation
Study start: Jan 2007
Primary completion: Mar 2016 (actual)
Study completion: Mar 2016 (actual)
First posted: 21 Mar 2007 (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.

This study is being conducted to see if Type 1 diabetes mellitus has any affect on learning, behavior and development in young children and whether there are associated changes on their MRI scan.

Detailed description

Study design

Time perspective: Cross-sectional

Who may qualify

Ages: 3 to 10 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child
Study population: please see inclusion and exclusion criteria

Key inclusion criteria (4 listed)

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

Key exclusion criteria (6 listed)

No 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

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

Not reported in the source record.

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.
Derived from this study: PubMed 22966090Aye T, Barnea-Goraly N, Ambler C, Hoang S, Schleifer K, Park Y, Drobny J, Wilson DM, Reiss AL, Buckingham BA. White matter structural differences in young children with type 1 diabetes: a diffusion tensor imaging study. Diabetes Care. 2012 Nov;35(11):2167-73. doi: 10.2337/dc12-0017. Epub 2012 Sep 10.
Stanford University Division of Pediatric Endocrinology websiteLink provided by the sponsor.

Related trials for Type 1 Diabetes Mellitus

Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
RecruitingPhase 1
Pharmacokinetics, Safety, and Immunogenicity Comparison of Bmab1700 and Opdivo® as Adjuvant Monotherapy in Participants With Melanoma
Melanoma
Active, not recruitingPhase 2
A Study of Botensilimab and Balstilimab for the Treatment of Colorectal Cancer
Metastatic Colorectal Cancer
Not yet recruiting
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RecruitingObservational study
Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
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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 Type 1 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.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00449891, which also lists 1 linked publication.

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.