Status:
RECRUITING
Project Dulce for Filipino-Americans With Type 2 Diabetes
Lead Sponsor:
Scripps Whittier Diabetes Institute
Collaborating Sponsors:
National Center for Advancing Translational Sciences (NCATS)
Conditions:
Diabetes Type 2
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This study aims to culturally adapt an existing American Diabetes Association (ADA)-recognized diabetes self-management and support or DSMES (Diabetes Self Management Education Support) program (Proje...
Detailed Description
Type 2 diabetes mellitus (T2DM) disproportionately affects racial and ethnic minority populations. Among Asian Americans, Filipino Americans (FA) have the second highest T2DM prevalence and have an in...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 17 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT05378620
Start Date
October 17 2022
End Date
December 31 2025
Last Update
February 4 2025
Active Locations (2)
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1
San Ysidro Health
National City, California, United States, 91950
2
Scripps Whittier Diabetes Institute
San Diego, California, United States, 92037