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 @ 3:21 PM
Ignite Modification Date:
2025-12-24 @ 3:21 PM
NCT ID:
NCT03469492
Eligibility Criteria:
Inclusion Criteria:
* 15 Type 2 DM subjects with HbA1C \> 7.5%
* 15 Type 1 DM subjects with HbA1C \> 7.5%
* Age 18-60
* BMI ≥18 kg/m2
* Weight ≤ 285 pounds
Exclusion Criteria:
* Creatinine \> 1.5 mg/dL, Hgb \< 10 mg/dL, ALT \> 2.5 X ULN,
* untreated thyroid disease,
* uncontrolled hypertension,
* known neurological disorders,
* untreated psychiatric disorders,
* malignancy,
* bleeding disorders,
* current or recent steroid use in last 3 months,
* illicit drug use;
* for women: pregnancy, actively seeking pregnancy, or breastfeeding; inability to enter
* MRI/MRS
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT03469492
Study Brief:
Protocol Section:
NCT03469492