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OpenTrials
Completed

NCT Number: NCT00879203

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

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Key information

Age range

7 year–16 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  • National Institutes of Health (NIH)

Registry information

Official study title

Glycemic Control, Brain Structure and Cognition in Youth With T1DM

Acronym: LO5/HY5

Important dates

Study start
2008
Primary completion
2013
Study completion
2016
First posted
Apr 9, 2009
Registry last updated
Nov 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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