Diabetes Prevention With Lifestyle Intervention and Metformin Escalation (LIME)

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.

Study Overview

• Status: Terminated
• Conditions: Diabetes
• Intervention / Treatment: Behavioral: Lifestyle Intervention; Drug: Metformin

Detailed 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.

The control arm of this study was never activated due to COVID-19 restrictions.

• Study Type: Interventional
• Enrollment (Actual): 114
• Phase: Phase 4

Contacts and Locations

Study Locations

• Barbados
  • Bridgetown, Barbados
    • University of the West Indies, Cavehill and Barbados Ministry of Health Polyclinics
• Puerto Rico
  • Carolina, Puerto Rico, 00984
    • Internal Medicine Clinic at the University of Puerto Rico Hospital
• Trinidad and Tobago
  • San Fernando, Trinidad and Tobago
    • Southwest Regional Health Authority, La Romaine Health Center
• Virgin Islands (U.S.)
  • Charlotte Amalie, Virgin Islands (U.S.)
    • Ministry of Health Clinics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 38 years to 58 years (Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; Highest risk pre-diabetic patients	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.; Other Names: Glucophage
No Intervention: Control; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Hemoglobin A1c (HbA1c)	Hemoglobin A1C (HbA1C) test was assessed via clinical tests.	Baseline and 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Weight (kg)	Weight in kilograms (kg) assessed via clinical tests.	Baseline and 6 months
Change in Systolic Blood Pressure	Systolic blood pressure assessed via clinical tests.	Baseline and 6 months
Change in Diastolic Blood Pressure	Diastolic blood pressure assessed via clinical tests.	Baseline and 6 months
Diabetes Risk Score	The Diabetes Risk Score has been designed to be a screening tool for identifying high-risk subjects in the population and for increasing awareness of the modifiable risk factors and healthy lifestyle. The score ranges from 0-20, with a higher score indicating higher risk.	6 months
Change in Self-Efficacy Score - Personal Control Scale	The Self-efficacy survey is an excerpt from the 43-item Risk Perception Survey for Developing Diabetes, designed for people at high risk for developing diabetes. It measures perceived comparative and environmental risk for developing diabetes. Scoring for the self-efficacy questions is done by an average and ranges from 1 to 4, with a higher score indicating more perceived risk.	Baseline and 6 months
Change in Self-Efficacy Score - Worry Scale	The Self-efficacy survey is an excerpt from the 43-item Risk Perception Survey for Developing Diabetes, designed for people at high risk for developing diabetes. It measures perceived comparative and environmental risk for developing diabetes. Scoring for the self-efficacy questions is done by an average and ranges from 1 to 4, with a higher score indicating more perceived risk.	6 months
Change in Physical Activity Level.	Change in physical activity level was assessed using the self-reported WHO Physical Activity Questionnaire	Baseline and 6 months
Change in Fruit and Vegetable Intake (Total Servings)	Total mean servings per day of fruit and vegetables self report via electronic survey.	Baseline and 6 months
Change in Sugar-sweetened Beverage Intake (Teaspoons Per Day)	Change in mean teaspoons per day of sugar-sweetened beverage intake self report via electronic survey.	Baseline and 6 months

Collaborators and Investigators

• Sponsor: Yale University
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI); National Institute on Minority Health and Health Disparities (NIMHD)
• Investigators: Principal Investigator: Marcella Nunez-Smith, MD, Yale University

Study record dates

Study Major Dates

• Study Start (Actual): July 30, 2018
• Primary Completion (Actual): December 1, 2021
• Study Completion (Actual): December 1, 2021

Study Registration Dates

• First Submitted: August 20, 2017
• First Submitted That Met QC Criteria: August 20, 2017
• First Posted (Actual): August 23, 2017

Study Record Updates

• Last Update Posted (Actual): February 6, 2024
• Last Update Submitted That Met QC Criteria: February 1, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Hypoglycemic Agents; Physiological Effects of Drugs; Metformin
• Other Study ID Numbers: 2000020105; 1K12HL138037-01 (U.S. NIH Grant/Contract); 1U54MD010711-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes