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

Glycemic Control, Brain Structure and Cognition in Youth With T1DM

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00879203

Acronym

LO5/HY5

Enrollment

230

Registered

2009-04-09

Start date

2008-11-30

Completion date

2016-10-31

Last updated

2016-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cognition, Type 1 Diabetes Mellitis

Keywords

Type 1 Diabetes Mellitis, Youth, Hypoglycemia, Hyperglycemia, Cognition, Memory, Brain Growth & Development, Magnetic Resonance Imaging

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

7 Years to 16 Years

Healthy volunteers

Yes

Inclusion 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)

Countries

United States

Outcome results