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

Cognition Clinical Trial

— LO5/HY5  

Official title:

Glycemic Control, Brain Structure and Cognition in Youth With T1DM

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00879203
• Other study ID #: 07-1258
• Secondary ID: R01DK064832-06
• Status: Completed
• Phase: N/A
• First received: April 7, 2009
• Last updated: October 31, 2016
• Start date: November 2008
• Est. completion date: October 2016

Study information

• Verified date: October 2016
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 230
• Est. completion date: October 2016
• Est. primary completion date: November 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 7 Years to 16 Years

Eligibility

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.

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cognition
• Diabetes Mellitus, Type 1
• Type 1 Diabetes Mellitis

Locations

Country	Name	City	State
United States	Washington University School of Medicine	St. Louis	Missouri

Sponsors (3)

Lead Sponsor	Collaborator
Washington University School of Medicine	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

External Links

•   Principal investigator's lab website