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 @ 4:23 AM
Ignite Modification Date:
2025-12-25 @ 4:23 AM
NCT ID:
NCT05378620
Eligibility Criteria:
Inclusion Criteria:
* Self-identified Filipino
* Diagnosed with T2DM
* Registered at Scripps Health or San Ysidro Health (or willing to register)
* HbA1c ≥7.5% and/or systolic blood pressure ≥ 140, and/or LDL-C ≥ 100 mg/dL within 90 days
* Able to speak, read, write, and comprehend in English and Tagalog
* Have access to a cell phone that can receive/send text messages throughout the study
Exclusion Criteria:
* Severe illness precluding frequent visits to clinic
* Liver function tests (ALT and AST) \> 3 times the upper limit of normal
* Body mass index ≤ 23 kg/cm
* History of malignancy, except subjects who have been disease-free for \>years, or whose only malignancy has been basal or squamous cell skin carcinoma
* Creatinine \>3.5
* History of drug or alcohol abuse within 12 months prior to enrollment
* Not a permanent resident in the area
* Current enrollee in Project Dulce
* Blood donation of one pint or more within the past 30 days, or plasma donation within 7 days prior to screening
* Anemia
* Type 1 or gestational diabetes
* Pregnant
* Are currently participating in another diabetes-related study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05378620
Study Brief:
Protocol Section:
NCT05378620