Clinical Trials Logo

Clinical Trial 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 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.

Clinical Trial 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 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. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT03258723
Study type Interventional
Source Yale University
Contact Saria Hassan, PhD
Phone + (203) 503-3010
Status Not yet recruiting
Phase Phase 4
Start date June 30, 2018
Completion date June 2021

See also
  Status Clinical Trial Phase
Completed NCT01855399 - Technologically Enhanced Coaching: A Program to Improve Diabetes Outcomes N/A
Completed NCT01819129 - Efficacy and Safety of FIAsp Compared to Insulin Aspart in Combination With Insulin Glargine and Metformin in Adults With Type 2 Diabetes Phase 3
Completed NCT01696266 - An International Survey on Hypoglycaemia Among Insulin-treated Patients With Diabetes
Recruiting NCT02356848 - STEP UP to Avert Amputation in Diabetes N/A
Completed NCT03292185 - A Trial to Investigate the Single Dose Pharmacokinetics of Insulin Degludec/Liraglutide Compared With Insulin Degludec and Liraglutide in Healthy Chinese Subjects Phase 1
Recruiting NCT03675360 - Low-Carbohydrate Dietary Pattern on Glycemic Outcomes Trial N/A
Active, not recruiting NCT03362528 - Database and Calibration of a Non-invasive Glucose Monitoring Device N/A
Completed NCT02249871 - Investigating the Influence of Omeprazole on the Pharmacokinetics of Oral Semaglutide in Healthy Subjects Phase 1
Completed NCT01850615 - Efficacy and Safety of FIAsp in a Basal-bolus Regimen Versus Basal Insulin Therapy, Both in Combination With Metformin in Adult Subjects With Type 2 Diabetes Phase 3
Active, not recruiting NCT03936062 - Replication of the TECOS Diabetes Trial in Healthcare Claims
Active, not recruiting NCT03936010 - Replication of the CANVAS Diabetes Trial in Healthcare Claims
Active, not recruiting NCT03936023 - Replication of the SAVOR-TIMI Diabetes Trial in Healthcare Claims
Active, not recruiting NCT03936049 - Replication of the LEADER Diabetes Trial in Healthcare Claims
Active, not recruiting NCT03936036 - Replication of the CARMELINA Diabetes Trial in Healthcare Claims
Completed NCT03288740 - A Trial to Assess the Pharmacokinetics, Safety and Tolerability of Semaglutide in Healthy Chinese Subjects Phase 1
Completed NCT02911948 - A Double-blinded Trial Comparing the Efficacy and Safety of Insulin Degludec/Liraglutide and Insulin Degludec Both in Combination With Metformin in Japanese Subjects With Type 2 Diabetes Mellitus Inadequately Controlled With Basal or Pre-mix/Combination Insulin Therapy and Oral Anti-diabetic Drugs Phase 3
Completed NCT02461589 - Dose-finding of Semaglutide Administered Subcutaneously Once Daily Versus Placebo and Liraglutide in Subjects With Type 2 Diabetes Phase 2
Not yet recruiting NCT03661177 - Reclaiming Indigenous Food and Health N/A
Not yet recruiting NCT03490253 - Diabetes and Depression Text Messaging Intervention N/A
Not yet recruiting NCT03626623 - Diabetic Foot Ulcer Study Comparing Cytal Wound Matrix 1-Layer to Standard of Care N/A