Diabetes Prevention With Lifestyle Intervention and Metformin Escalation

• Status: Active, not recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yale University
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI); National Institute on Minority Health and Health Disparities (NIMHD)
• Treatments: Metformin

Criteria

Inclusion Criteria:

• 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 Criteria:

• Pregnant

• eGFR<45 mL/min/1.73 m2

• Prescribed Metformin and randomized to the control arm