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Glycemic Control, Brain Structure and Cognition in Youth With Type 1 Diabetes (T1DM)

NCT ID: NCT00879203

Last Updated: 2016-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

230 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-11-30

Study Completion Date

2016-10-31

Brief Summary

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LO5 study: The investigators are inviting a new group of youth (ages 7-16) who have been recently diagnosed with type 1 diabetes and their non-diabetic siblings. These youth will complete cognitive tests and a MRI scan of the brain. This scan uses strong magnets to obtain pictures and does not involve any radiation or injections. The investigators will recruit patients within three months of their diagnosis date. The study entails 1 study visit that lasts 3.5 hours. Evening and weekend times are available. The investigators plan to enroll 135 participants.

HY5 study: The investigators are inviting a cohort of youth and young adults (ages 9-21) with type 1 diabetes and their non-diabetic siblings for a follow-up to a study they have already completed. This group of people will complete several memory and thinking tests along with several MRI scans of their brain, just as they did at their previous visits. The investigators plan to enroll 150 participants.

Detailed Description

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Conditions

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Type 1 Diabetes Mellitis Cognition

Keywords

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Type 1 Diabetes Mellitis Youth Hypoglycemia Hyperglycemia Cognition Memory Brain Growth & Development Magnetic Resonance Imaging

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Type 1 Diabetes (T1DM)

Youth and young adults with T1DM

No interventions assigned to this group

Non diabetic siblings

Non diabetic, young siblings of T1DM participants

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Between the ages of 7 and 16
* Diagnosed with type 1 diabetes within 3 months


* Between the ages of 7 and 16

Exclusion Criteria

* Pregnant or lactating
* Chronic disease other than T1DM, well-controlled asthma, or Hashimoto's thyroiditis
* Other current serious medical illness
* Psychiatric illness
* Psychoactive drug dependence
* Neurological illness (except T1DM-related): stroke, seizure, major loss of consciousness, head injuries, encephalitis, or hydrocephalus, blindness, deafness
* 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)
* Use of dopamine depleting agents or stimulants such as Ritalin, Cylert, Adderall
* Pre-maturity at birth of more than 4 wks early with complications (e.g. on respirator at NICU)
* Inability to complete MRI scan (e.g. claustrophobia, metal implants)
* Full set (top and bottom) of orthodontic braces (Half set braces, fillings, and retainers are OK)


* Same as above (except cannot have type 1 diabetes)

HY5: Must have been a participant in our earlier study.
Minimum Eligible Age

7 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role collaborator

Washington University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tamara G. Hershey, PhD

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

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Washington University School of Medicine

St Louis, Missouri, United States

Site Status

Countries

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United States

References

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Perantie DC, Koller JM, Weaver PM, Lugar HM, Black KJ, White NH, Hershey T. Prospectively determined impact of type 1 diabetes on brain volume during development. Diabetes. 2011 Nov;60(11):3006-14. doi: 10.2337/db11-0589. Epub 2011 Sep 27.

Reference Type DERIVED
PMID: 21953611 (View on PubMed)

Other Identifiers

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R01DK064832-06

Identifier Type: NIH

Identifier Source: secondary_id

View Link

07-1258

Identifier Type: -

Identifier Source: org_study_id