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:
2025-12-25 @ 4:51 AM
Ignite Modification Date:
2025-12-25 @ 4:51 AM
NCT ID:
NCT00024518
Eligibility Criteria:
* INCLUSION CRITERIA:
T1DM of less than 6 weeks duration in patients between 3 and 25 years of age.
Besides T1DM, no concurrent illness.
EXCLUSION CRITERIA:
Treatment with immunosuppressive or immunostimulatory medications such as azathioprine, nicotinamide, superoxide dismutase-desferroxamine, aminoguanidine, oral insulin or other experimental therapies at the present time or in the past.
Abnormal pre-treatment white blood cell count (WBC) or thrombocytopenia.
Known active diseases, e.g. cardiac, renal, hepatic diseases or immunodeficiency.
History of cancer, neuropathy seizure disorders (except typical history of febrile seizures in childhood), peripheral vascular disease, coagulation abnormalities, autoimmune disease (except type 1 diabetes) or cerebrovascular disease.
Ongoing use of medications known to influence glucose tolerance (e.g. sulfonylureas, metformin, diphenylhydantoin, thiazide or other potassium depleting diuretics, beta-adrenergic blockers, niacin) except insulin.
Any medical condition that, in the opinion of the investigator, will interfere with the safe completion of the trial.
Inability to give informed consent or assent.
Participation in a clinical trial within the previous 6 weeks.
Lactating or pregnant female individual (individuals will be advised not to volunteer for the protocol if they plan to become pregnant during the time of the study and they are instructed to use an effective method of contraception).
Age above 25 years, since there may be several subtypes of T1DM.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
3 Years
Maximum Age:
25 Years
Study:
NCT00024518
Study Brief:
Protocol Section:
NCT00024518