NCT00879203

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
230

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2008

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2008

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 7, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 9, 2009

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
2.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

November 2, 2016

Status Verified

October 1, 2016

Enrollment Period

5 years

First QC Date

April 7, 2009

Last Update Submit

October 31, 2016

Conditions

Type 1 Diabetes MellitisCognition

Keywords

Type 1 Diabetes MellitisYouthHypoglycemiaHyperglycemiaCognitionMemoryBrain Growth & DevelopmentMagnetic Resonance Imaging

Study Arms (2)

Type 1 Diabetes (T1DM)

Youth and young adults with T1DM

Non diabetic siblings

Non diabetic, young siblings of T1DM participants

Eligibility Criteria

Age7 Years - 16 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

LO5: Youth with type 1 diabetes (T1DM) between the ages of 7-16 who have been diagnosed within the previous 3 months. Non-diabetic siblings of the participants with T1DM aged 7-16 years old. HY5: Youth and young adults (ages 9-21) who have already completed an earlier study with the lab.

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Publications (1)

  • 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.

    PMID: 21953611DERIVED

MeSH Terms

Conditions

HypoglycemiaHyperglycemia

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Tamara G. Hershey, PhD

    Washington University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 7, 2009

First Posted

April 9, 2009

Study Start

November 1, 2008

Primary Completion

November 1, 2013

Study Completion

October 1, 2016

Last Updated

November 2, 2016

Record last verified: 2016-10

Locations

US(1)