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Diabetes Prevention With Lifestyle Intervention and Metformin Escalation (LIME)

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ClinicalTrials.gov Identifier: NCT03258723
Recruitment Status : Recruiting
First Posted : August 23, 2017
Last Update Posted : March 6, 2020
Sponsor:
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
National Institute on Minority Health and Health Disparities (NIMHD)
Information provided by (Responsible Party):
Yale University

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.


Condition or disease Intervention/treatment Phase
Diabetes Behavioral: Lifestyle Intervention Drug: Metformin Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 330 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
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.

Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Diabetes Prevention With Lifestyle Intervention and Metformin Escalation
Actual Study Start Date : July 30, 2018
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine


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 Name: 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.



Primary Outcome Measures :
  1. change in hemoglobin A1c [ Time Frame: 12-months ]
    assessed via clinical tests, reported at the group level


Secondary Outcome Measures :
  1. weight [ Time Frame: 6 months ]
    assessed via clinical tests

  2. blood pressure [ Time Frame: 6 months ]
    assessed via clinical tests

  3. diabetes risk score [ Time Frame: 6 months ]
    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.

  4. self-efficacy score [ Time Frame: 6 months ]
    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.

  5. physical activity level [ Time Frame: 6 months ]
    self-reported using the WHO Physical Activity Questionnaire

  6. fruit and vegetable intake [ Time Frame: 6 months ]
    self report via electronic survey

  7. sugar-sweetened beverage intake [ Time Frame: 6 months ]
    self report via electronic survey



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03258723


Contacts
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Contact: Saria Hassan, PhD + (203) 503-3010 saria.hassan@yale.edu

Locations
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United States, New York
Flatbush Family Health Center at NYU Langone Withdrawn
Brooklyn, New York, United States, 11203
Internal Medicine Associates at Mt. Sinai Withdrawn
New York, New York, United States, 10029
Barbados
University of the West Indies, Cavehill and Barbados Ministry of Health Polyclinics Recruiting
Bridgetown, Barbados
Contact: Joseph Herbert, MD    2462347715    familymedicinebarbados@gmail.com   
Contact: Natasha Sobers, MD    2462400313    natasha.sobers@cavehill.uwi.edu   
Puerto Rico
Internal Medicine Clinic at the University of Puerto Rico Hospital Recruiting
Carolina, Puerto Rico, 00984
Contact: Elsie Cruz, MD       elsie.cruz1@upr.edu   
Contact: Enid J Garcia-Rivera, MD    (787) 701-1121    enid.garcia3@upr.edu   
Trinidad and Tobago
Southwest Regional Health Authority, La Romaine Health Center Recruiting
San Fernando, Trinidad and Tobago
Contact: Albert Persaud, MD    1-868-225-1802    albertpersaud@swrha.co.tt   
Contact: Kavita Dharamraj, MD    1-868-730-3418    kavitadharamraj@swrha.co.tt   
Virgin Islands (U.S.)
Ministry of Health Clinics Recruiting
Charlotte Amalie, Virgin Islands (U.S.)
Contact: Lyna Fredericks         
Sponsors and Collaborators
Yale University
National Heart, Lung, and Blood Institute (NHLBI)
National Institute on Minority Health and Health Disparities (NIMHD)
Investigators
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Principal Investigator: Marcella Nunez-Smith, MD Yale University
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Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT03258723    
Other Study ID Numbers: 2000020105
1K12HL138037-01 ( U.S. NIH Grant/Contract )
1U54MD010711-01 ( U.S. NIH Grant/Contract )
First Posted: August 23, 2017    Key Record Dates
Last Update Posted: March 6, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs