Clinical trial NCT03258723: Diabetes Prevention With Lifestyle Intervention and Metformin Escalation
Official title: Diabetes Prevention With Lifestyle Intervention and Metformin Escalation
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Diabetes
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2017-08-23
Enrollment: 114
Sex: ALL
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: PREVENTION

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.

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.

Eligibility 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

Primary outcomes:
measure: Change in Hemoglobin A1c (HbA1c)
timeFrame: Baseline and 12 months
Secondary outcomes:
measure: Change in Weight (kg)
timeFrame: Baseline and 6 months
measure: Change in Systolic Blood Pressure
timeFrame: Baseline and 6 months
measure: Change in Diastolic Blood Pressure
timeFrame: Baseline and 6 months
measure: Diabetes Risk Score
timeFrame: 6 months
measure: Change in Self-Efficacy Score - Personal Control Scale
timeFrame: Baseline and 6 months
measure: Change in Self-Efficacy Score - Worry Scale
timeFrame: 6 months
measure: Change in Physical Activity Level.
timeFrame: Baseline and 6 months
measure: Change in Fruit and Vegetable Intake (Total Servings)
timeFrame: Baseline and 6 months
measure: Change in Sugar-sweetened Beverage Intake (Teaspoons Per Day)
timeFrame: Baseline and 6 months
Other outcomes:
Locations:
city: Bridgetown
country: Barbados
facility: University of the West Indies, Cavehill and Barbados Ministry of Health Polyclinics
city: Carolina
country: Puerto Rico
facility: Internal Medicine Clinic at the University of Puerto Rico Hospital
city: San Fernando
country: Trinidad and Tobago
facility: Southwest Regional Health Authority, La Romaine Health Center
city: Charlotte Amalie
country: Virgin Islands (U.S.)
facility: Ministry of Health Clinics
Study officials:
affiliation: Yale University
name: Marcella Nunez-Smith, MD
role: PRINCIPAL_INVESTIGATOR
References: