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Diabetes Prevention With Lifestyle Intervention and Metformin Escalation

NCT03258723 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 114

Last updated 2024-02-06

Study results available
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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.

Conditions

Interventions

BEHAVIORAL

Lifestyle Intervention

The lifestyle intervention consists of a series of workshops adapted from the East Harlem Partnerships for Diabetes Prevention that discuss diabetes prevention, finding and affording healthy foods, label reading, physical activity, planning a healthy plate, making traditional foods healthy and portion control. The newly launched East Harlem Diabetes Prevention (EHDP) project's mobile app, iHEED will be used by intervention participants to help reinforce the content they learn during the workshop series.

DRUG

Metformin

At 6 months, intervention participants who have not been able to lose weight or bring their HbA1c below the high risk range of 6% (determined by point-of-care testing) will have Metformin prescribed by their provider. Metformin will be prescribed at 500mg twice a day. If no change is seen at 12 months follow up, the dose will be increased to 850mg twice a day.

Sponsors & Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH

  • National Institute on Minority Health and Health Disparities (NIMHD)

    collaborator NIH

  • Yale University

    lead OTHER

Principal Investigators

  • Marcella Nunez-Smith, MD · Yale University

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-30
Primary Completion
2021-12-01
Completion
2021-12-01
FDA Drug
Yes

Countries

  • Barbados
  • Puerto Rico
  • Trinidad and Tobago
  • Virgin Islands

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03258723 on ClinicalTrials.gov