Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:32 PM
Ignite Modification Date:
2025-12-24 @ 7:32 PM
NCT ID:
NCT00879203
Eligibility 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)
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.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
7 Years
Maximum Age:
16 Years
Study:
NCT00879203
Study Brief:
Protocol Section:
NCT00879203