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

The Washington University

Status

Completed

Conditions

Cognition

Type 1 Diabetes Mellitis

Study type

Observational

Funder types

Other

NIH

Identifiers

NCT00879203

R01DK064832-06 (U.S. NIH Grant/Contract)

07-1258

Details and patient eligibility

About

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.

Enrollment

230 patients

Sex

All

Ages

7 to 16 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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)