Diabetes Clinical Trial
Official title:
Diabetes Prevention With Lifestyle Intervention and Metformin Escalation
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 seeks to test the hypothesis that implementation of a lifestyle
intervention, with escalation to Metformin therapy will lower the incidence of diabetes among
the highest risk pre-diabetic individuals of Caribbean-descent.
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 individuals in Region 2, Trinidad and Barbados. The investigators will have
five clinical intervention sites situated in New York - 2, Puerto Rico -1, Barbados -1,
Trinidad -1 and US Virgin Islands -1. These sites were chosen because of the investigators'
strong research network in these locations, and to enable us to address diabetes disparities
due to geographic differences. The investigators will first modify an established lifestyle
modification workshop series developed by the East Harlem Partnership for Diabetes Prevention
(EHPDP) for use in the community, 10to target the population at the involved clinical sites.
The investigators plan to adapt the D-CLIP protocol and escalate to Metformin therapy for the
highest risk pre-diabetic patients whose hemoglobin A1c (HbA1c) has not improved or who
remain morbidly obese.
The investigators will leverage our existing robust research infrastructure and network at
the five sites through our Eastern Caribbean Health Outcomes Research Network (ECHORN) and
now the Yale Transdisciplinary Collaborative center for Health Disparities focused on
Precision Medicine (Yale-TCC). ECHORN is a research collaboration funded by the NIMHD
(U2458849938) to address the burden of chronic disease in USVI, PR and the Eastern Caribbean.
The Yale-TCC (U54MD010711) leverages the infrastructure and knowledge of the ECHORN, expands
to include New York and New Jersey and focuses on diabetes and hypertension. The
investigators' network includes community advisory boards as well as policy delegations that
are well suited to inform this project and its expansion into routine healthcare practice and
policy.
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