Glycemic Control, Brain Structure and Cognition in Youth With Type 1 Diabetes (T1DM) (LO5/HY5)

This study is currently recruiting participants.
Verified November 2011 by Washington University School of Medicine
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT00879203
First received: April 7, 2009
Last updated: November 2, 2011
Last verified: November 2011

April 7, 2009
November 2, 2011
November 2008
 
 
 
Complete list of historical versions of study NCT00879203 on ClinicalTrials.gov Archive Site
 
 
 
 
 
Glycemic Control, Brain Structure and Cognition in Youth With Type 1 Diabetes (T1DM)
Glycemic Control, Brain Structure and Cognition in Youth With T1DM

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.

 
Observational
Observational Model: Case Control
Time Perspective: Prospective
 
Non-Probability Sample

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.

  • Type 1 Diabetes Mellitis
  • Cognition
 
  • Type 1 Diabetes (T1DM)
    Youth and young adults with T1DM
  • Non diabetic siblings
    Non diabetic, young siblings of T1DM participants
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. Epub 2011 Sep 27.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
285
November 2013
 

LO5:

Inclusion Criteria for Participants with Type 1 Diabetes:

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

Inclusion Criteria for Participants without Type 1 Diabetes:

  • Between the ages of 7 and 16

Exclusion Criteria for Participants with Type 1 Diabetes:

  • 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)

Exclusion Criteria for Participants without Type 1 Diabetes:

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

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

Both
7 Years to 16 Years
Yes
Contact: Aiden Bondurant, B.A. 314-362-5573 galarzaa@npg.wustl.edu
United States
 
NCT00879203
07-1258, RO1-DK-064832-06
No
Washington University School of Medicine
Washington University School of Medicine
National Institutes of Health (NIH)
Principal Investigator: Tamara G. Hershey, PhD Washington University School of Medicine
Washington University School of Medicine
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP