Status:
COMPLETED
A Patient-Centered Strategy for Improving Diabetes Prevention in Urban American Indians
Lead Sponsor:
Stanford University
Collaborating Sponsors:
San Jose State University
Patient-Centered Outcomes Research Institute
Conditions:
Diabetes Mellitus, Type 2
Metabolic Syndrome
Eligibility:
All Genders
21+ years
Phase:
NA
Brief Summary
The goal of the proposed research is to identify effective patient-centered strategies to prevent diabetes in high-risk populations in real world settings. The investigators will accomplish this by co...
Detailed Description
The goal of the proposed research is to identify effective patient-centered strategies to prevent diabetes in high-risk populations in real world settings. The investigators will accomplish this by co...
Eligibility Criteria
Inclusion
- Urban of Indigenous Ancestry from the Americas (North, Central and South America)
- Men and women
- BMI Between 30-55
- Not diagnosed with Type II Diabetes
- At least one of the following criterion
- Triglycerides: 150mg/dL or higher
- Reduced HDL: \<40mg/dL (men); \<50mg/dL (women)
- Blood pressure: \>130/80 or current treatment with antihypertensives
- Fasting glucose: \>100mg/dL
Exclusion
- Significant medical comorbidities, including uncontrolled metabolic disorders (e.g., thyroid, diabetes, renal, liver), unstable heart disease, heart failure, and ongoing substance abuse;
- On greater than 10 prescription medications.
- Psychiatric disorders requiring atypical antipsychotics or multiple medications;
- Inappropriate for moderate exercise according to the Revised Physical Activity Readiness Questionnaire;
- Pregnant, planning to become pregnant, or lactating;
- Family household member already enrolled in the study;
- Already enrolled or planning to enroll in a clinical trial that would limit full participation in the study;
- Resident of a long term care facility;
- Lack of spoken English by patient or a household member \> 18 y who can serve as interpreter;
- Plans to move during the study period (9 months post-randomization);
- Investigator discretion for clinical safety or adherence reasons (e.g., unstable housing, chronic pain).
Key Trial Info
Start Date :
June 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 30 2017
Estimated Enrollment :
207 Patients enrolled
Trial Details
Trial ID
NCT02266576
Start Date
June 1 2015
End Date
August 30 2017
Last Update
August 26 2025
Active Locations (2)
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1
Timpany Center of San Jose State University
San Jose, California, United States, 95128
2
Stanford University School of Medicine
Stanford, California, United States, 94305