Diabetes Prevention With Lifestyle Intervention and Metformin Escalation (LIME)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03258723|
Recruitment Status : Recruiting
First Posted : August 23, 2017
Last Update Posted : March 6, 2020
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|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||330 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||
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)|
|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|
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.
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.
- change in hemoglobin A1c [ Time Frame: 12-months ]assessed via clinical tests, reported at the group level
- weight [ Time Frame: 6 months ]assessed via clinical tests
- blood pressure [ Time Frame: 6 months ]assessed via clinical tests
- 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.
- 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.
- physical activity level [ Time Frame: 6 months ]self-reported using the WHO Physical Activity Questionnaire
- fruit and vegetable intake [ Time Frame: 6 months ]self report via electronic survey
- sugar-sweetened beverage intake [ Time Frame: 6 months ]self report via electronic survey
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
|Contact: Saria Hassan, PhD||+ (203) firstname.lastname@example.org|
|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|
|University of the West Indies, Cavehill and Barbados Ministry of Health Polyclinics||Recruiting|
|Contact: Joseph Herbert, MD 2462347715 email@example.com|
|Contact: Natasha Sobers, MD 2462400313 firstname.lastname@example.org|
|Internal Medicine Clinic at the University of Puerto Rico Hospital||Recruiting|
|Carolina, Puerto Rico, 00984|
|Contact: Elsie Cruz, MD email@example.com|
|Contact: Enid J Garcia-Rivera, MD (787) 701-1121 firstname.lastname@example.org|
|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 email@example.com|
|Contact: Kavita Dharamraj, MD 1-868-730-3418 firstname.lastname@example.org|
|Virgin Islands (U.S.)|
|Ministry of Health Clinics||Recruiting|
|Charlotte Amalie, Virgin Islands (U.S.)|
|Contact: Lyna Fredericks|
|Principal Investigator:||Marcella Nunez-Smith, MD||Yale University|