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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00879203
Recruitment Status : Completed
First Posted : April 9, 2009
Last Update Posted : November 2, 2016
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Washington University School of Medicine

Tracking Information
First Submitted Date April 7, 2009
First Posted Date April 9, 2009
Last Update Posted Date November 2, 2016
Study Start Date November 2008
Actual Primary Completion Date November 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Glycemic Control, Brain Structure and Cognition in Youth With Type 1 Diabetes (T1DM)
Official Title Glycemic Control, Brain Structure and Cognition in Youth With T1DM
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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.

Condition
  • Type 1 Diabetes Mellitis
  • Cognition
Intervention Not Provided
Study Groups/Cohorts
  • Type 1 Diabetes (T1DM)
    Youth and young adults with T1DM
  • Non diabetic siblings
    Non diabetic, young siblings of T1DM participants
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: October 31, 2016)
230
Original Estimated Enrollment
 (submitted: April 8, 2009)
285
Actual Study Completion Date October 2016
Actual Primary Completion Date November 2013   (Final data collection date for primary outcome measure)
Eligibility 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.

Sex/Gender
Sexes Eligible for Study: All
Ages 7 Years to 16 Years   (Child)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00879203
Other Study ID Numbers 07-1258
R01DK064832-06 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Current Responsible Party Washington University School of Medicine
Original Responsible Party Tamara G. Hershey, PhD, Washington University School of Medicine
Current Study Sponsor Washington University School of Medicine
Original Study Sponsor Same as current
Collaborators
  • National Institutes of Health (NIH)
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Principal Investigator: Tamara G. Hershey, PhD Washington University School of Medicine
PRS Account Washington University School of Medicine
Verification Date October 2016