Diabetes Prevention With Lifestyle Intervention and Metformin Escalation

NCT03258723 | Terminated Phase 4 Results FDA Drug

• 3 other identifiers: 20000201051K12HL138037-011U54MD010711-01
• Study Type: interventional
• Target: 114
• Locations: 4 countries
• Sites: 4

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 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

Diabetes

Outcome Measures

Primary Outcomes (1)

• Change in Hemoglobin A1c (HbA1c)

  Hemoglobin A1C (HbA1C) test was assessed via clinical tests.

  Baseline and 12 months

Secondary Outcomes (9)

• Change in Weight (kg)

  Baseline and 6 months

• Change in Systolic Blood Pressure

  Baseline and 6 months

• Change in Diastolic Blood Pressure

  Baseline and 6 months

• Diabetes Risk Score

  6 months

• Change in Self-Efficacy Score - Personal Control Scale

  Baseline and 6 months

Study Arms (2)

Intervention

EXPERIMENTAL

Highest risk pre-diabetic patients

Behavioral: Lifestyle Intervention; Drug: Metformin

Control

NO INTERVENTION

Control participants in existing ECHORN sites (Puerto Rico, Barbados and Trinidad) will be recruited. ECS does not have a recruitment site in New York; therefore, the New York LIME sites will need to recruit their own control participants, through random assignment of consented participants into the intervention and control groups.

Interventions

Lifestyle Intervention BEHAVIORAL

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.

Intervention

Metformin DRUG

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.

Also known as: Glucophage

Intervention

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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%

You may not qualify if:

• Pregnant
• eGFR\<45 mL/min/1.73 m2
• Prescribed Metformin and randomized to the control arm

Sponsors & Collaborators

• Yale University: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Study Sites (4)

University of the West Indies, Cavehill and Barbados Ministry of Health Polyclinics

Bridgetown, Barbados

Location

Internal Medicine Clinic at the University of Puerto Rico Hospital

Carolina, 00984, Puerto Rico

Location

Southwest Regional Health Authority, La Romaine Health Center

San Fernando, Trinidad and Tobago

Location

Ministry of Health Clinics

Charlotte Amalie, Virgin Islands

Location

Related Publications (1)

• Hassan S, Sobers NP, Paul-Charles J, Herbert J, Dharamraj K, Galusha D, Cruz E, Garcia-Rivera E, Fredericks L, Arniella G, Cattamanchi A, Adams OP, Maharaj RG, Nazario CM, Nunez M, Nunez-Smith M. Diabetes prevention in the Caribbean using lifestyle intervention and Metformin escalation (LIME): results from a quasi-experimental study. BMC Public Health. 2025 Nov 22;25(1):4409. doi: 10.1186/s12889-025-25291-7.

  PMID: 41275221 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Metformin

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Results Point of Contact

• Title: Marcella Nunez-Smith, MD, MHS
• Organization: Yale School of Medicine

marcella.nunez-smith@yale.edu

(203) 785-6454

Study Officials

• Marcella Nunez-Smith, MD

  Yale University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patient Recruitment: The investigators are targeting the highest risk pre-diabetic patients for this study. Patient recruitment will occur through the involved health clinics. Control Participants Control participants in existing ECHORN sites (Puerto Rico, Barbados and Trinidad) will be recruited from the ECHORN Cohort Study (ECS). ECS does not have a recruitment site in New York; therefore, the New York LIME sites will need to recruit their own control participants, through random assignment of consented participants into the intervention and control groups. These participants will be offered a delayed intervention at the end of 2.5years, given the evidence supporting behavioral modification for diabetes prevention.

Study Record Dates

• First Submitted: August 20, 2017
• First Posted: August 23, 2017
• Study Start: July 30, 2018
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: February 6, 2024
• Results First Posted: December 22, 2022

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

VI (1); BA (1); TR (1); PR (1)