Status:
WITHDRAWN
Home-based Prediabetes Care in Acoma Pueblo - Study 1
Lead Sponsor:
University of New Mexico
Conditions:
PreDiabetes
Eligibility:
All Genders
21-60 years
Phase:
NA
Brief Summary
The prevalence of overweight, obesity and T2D among American Indians (AIs) in the Albuquerque service area of Indian Health Services (IHS) serving all pueblos in New Mexico including Pueblo of Acoma i...
Detailed Description
The investigators are conducting a prospective, randomized clinical trial of 'Home Base Diabetes Care (HBDC)' versus usual care (delayed HBDC beginning 12 months after enrollment) among 150 Acoma citi...
Eligibility Criteria
Inclusion
- Male and female Acoma tribal members aged 21-60 years who have:
- BMI ≥27 kg/m2 and/or a waist circumference \>90 cm for men or \>80 cm for women;
- A high risk of developing T2D as defined by an A1c between 5.7-6.4% and/or a baseline fasting glucose of 100-125 mg/dl;
- Willingness to consent to randomization
Exclusion
- prior diagnosis of diabetes, excluding gestational diabetes;
- pregnant;
- No history of heart disease or advanced liver or kidney disease by participant report;
- diagnosis of terminal cancer in the last 5 years by report;
- taking medications that alter glucose homeostasis
Key Trial Info
Start Date :
March 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2024
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04029298
Start Date
March 1 2023
End Date
July 1 2024
Last Update
July 3 2024
Active Locations (1)
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1
Pueblo of Acoma
Acoma Pueblo, New Mexico, United States, 87034