CompletedNot Applicable

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

United States230 participantsStarted 2008-11

Plain-language 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.

Who can participate

Age range

7 Years – 16 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

Trial details

NCT IDNCT00879203

SponsorWashington University School of Medicine

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2013-11

View on ClinicalTrials.gov More Type 1 Diabetes Mellitis trials