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

This study is currently recruiting participants.
Verified November 2012 by Washington University School of Medicine
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT00879203
First received: April 7, 2009
Last updated: November 27, 2012
Last verified: November 2012
History of Changes
  Purpose

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.


Condition
Type 1 Diabetes Mellitis
Cognition

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Glycemic Control, Brain Structure and Cognition in Youth With T1DM

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Washington University School of Medicine:

Estimated Enrollment: 285
Study Start Date: November 2008
Estimated Study Completion Date: November 2013
Groups/Cohorts
Type 1 Diabetes (T1DM)
Youth and young adults with T1DM
Non diabetic siblings
Non diabetic, young siblings of T1DM participants

  Eligibility

Ages Eligible for Study:   7 Years to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-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.

Criteria

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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00879203

Contacts
Contact: Angie Starnes, RN 314-286-1107 starnesa@kids.wustl.edu

Locations
United States, Missouri
Washington University School of Medicine Recruiting
St. Louis, Missouri, United States, 63110
Contact: Angie Starnes, RN     314-286-1107     starnesa@kids.wustl.edu    
Principal Investigator: Tamara G Hershey, PhD            
Sponsors and Collaborators
Washington University School of Medicine
National Institutes of Health (NIH)
Investigators
Principal Investigator: Tamara G. Hershey, PhD Washington University School of Medicine
  More Information

Additional Information:
Principal investigator's lab website  This link exits the ClinicalTrials.gov site

No publications provided by Washington University School of Medicine

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00879203     History of Changes
Other Study ID Numbers: 07-1258, RO1-DK-064832-06
Study First Received: April 7, 2009
Last Updated: November 27, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Washington University School of Medicine:
Type 1 Diabetes Mellitis
Youth
Hypoglycemia
Hyperglycemia
 Cognition
Memory
Brain Growth & Development
Magnetic Resonance Imaging

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
 Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on May 19, 2013