Status:
TERMINATED
Diabetes Prevention With Lifestyle Intervention and Metformin Escalation
Lead Sponsor:
Yale University
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
National Institute on Minority Health and Health Disparities (NIMHD)
Conditions:
Diabetes
Eligibility:
All Genders
40-60 years
Phase:
PHASE4
Brief Summary
Specific Aim: Implement an evidence-based diabetes prevention pragmatic trial for high risk pre-diabetic individuals of Caribbean-descent to reduce the incidence of diabetes. Hypothesis: This study s...
Detailed Description
The investigators propose to conduct a pragmatic trial that tests the effectiveness of lifestyle modification and Metformin use in minority populations. Our study population is Caribbean-descent indiv...
Eligibility Criteria
Inclusion
- BMI\>25 or WC\>88/102cm
- No history of type I or type II diabetes or gestational diabetes
- Not on blood sugar altering medication
- Ability to attend weekly sessions
- HbA1c 6-6.4%
Exclusion
- Pregnant
- eGFR\<45 mL/min/1.73 m2
- Prescribed Metformin and randomized to the control arm
Key Trial Info
Start Date :
July 30 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2021
Estimated Enrollment :
114 Patients enrolled
Trial Details
Trial ID
NCT03258723
Start Date
July 30 2018
End Date
December 1 2021
Last Update
February 6 2024
Active Locations (4)
Enter a location and click search to find clinical trials sorted by distance.
1
University of the West Indies, Cavehill and Barbados Ministry of Health Polyclinics
Bridgetown, Barbados
2
Internal Medicine Clinic at the University of Puerto Rico Hospital
Carolina, Puerto Rico, 00984
3
Southwest Regional Health Authority, La Romaine Health Center
San Fernando, Trinidad and Tobago
4
Ministry of Health Clinics
Charlotte Amalie, Virgin Islands