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 @ 9:06 PM
Ignite Modification Date:
2025-12-24 @ 9:06 PM
NCT ID:
NCT01883804
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of Type 1 Diabetes Mellitus
* 18-46 years of age
* Residual C-peptide production during screening
* Positive for at least one islet autoantibody: insulin (if only insulin autoantibody positive, determination must be within two weeks of insulin initiation), GAD-65, IA-2 or ZnT8
* Positive for at least one gene encoding HLA-DQ8 (DQB\*0302)
* No history of difficult to control hypertension (defined as requiring \> 2 anti-hypertensive medications)
* Agree to intensive management of diabetes with an HgbA1c goal of \< 8.0%
* If female: (a) surgically sterile or (b) postmenopausal or (c) if of reproductive potential, willing to use medically acceptable birth control (e.g. female hormonal contraception, barrier methods or sterilization.) until study completion
* If male and of reproductive potential, willing to use medically acceptable birth control until study completion, unless the female partner is postmenopausal or surgically sterile
Exclusion Criteria:
* Unable or unwilling to comply with the requirements of the study protocol
* No HLA-DQ8 gene (DQB\*0302)
* Difficult to control hypertension (defined as requiring \> 2 anti-hypertensive medications)
* History of postural hypotension or Addison's disease
* Body Mass Index (BMI) \> 30 kg/m2
* Unstable blood sugar control defined as one or more episodes of severe hypoglycemia (defined as hypoglycemia that required the assistance of another person) within the last 30 days
* Administration of an experimental agent for T1D at any time or use of an experimental device for T1D within 30 days of screening, unless approved by the study PI
* History of any organ transplant, including islet cell transplant
* Active autoimmune or immune deficiency disorder (e.g. sarcoidosis, rheumatoid arthritis)
* Anticipated pregnancy during the 12 week study period
* Any social or medical condition that would, in the opinion of the investigator, prevent complete participation in the study or that would pose a significant hazard to the subjects' participation
* History of active substance abuse within 12 months of screening
* A psychiatric or medical disorder that would prevent giving informed consent
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
46 Years
Study:
NCT01883804
Study Brief:
Protocol Section:
NCT01883804