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DiabetesPhase 4LIMENCT03258723

Diabetes Prevention With Lifestyle Intervention and Metformin Escalation

A Phase 4 study testing Lifestyle Intervention and Metformin in people with Diabetes, run by Yale University at 4 sites in 4 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 40 to 60 years
Conditions the study is for
Diabetes
What is being tested?
Lifestyle Intervention and Metformin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
114 participants
Where
4 sitesin 4 countries
Study dates
30 Jul 2018to 1 Dec 2021
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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%

Who cannot join

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

Trial locations and contacts

4 sites in 4 countries.

4 sites in 4 countries

Barbados1 site

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

    Bridgetown

Puerto Rico1 site

  • Internal Medicine Clinic at the University of Puerto Rico Hospital

    Carolina, 00984

Other trials in Puerto Rico

Trinidad and Tobago1 site

  • Southwest Regional Health Authority, La Romaine Health Center

    San Fernando

Other trials in Trinidad and Tobago

Virgin Islands1 site

  • Ministry of Health Clinics

    Charlotte Amalie

About this study

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.

Read the 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.

Conditions
Diabetes
Being tested
Lifestyle Intervention, Metformin
Medical subject headings
Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Lifestyle InterventionBehavioural

    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.

  • MetforminDrug

    Also called Glucophage

    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.

Study groups in NCT03258723
Study groupRoleWhat they receive
InterventionExperimentalHighest risk pre-diabetic patients
Receives: Behavioral: Lifestyle Intervention; Drug: Metformin
ControlNo interventionControl 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 being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Hemoglobin A1c (HbA1c)

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

    Measured: Baseline and 12 months

Secondary outcomes (9)

  1. Change in Weight (kg)

    Weight in kilograms (kg) assessed via clinical tests.

    Measured: Baseline and 6 months

  2. Change in Systolic Blood Pressure

    Systolic blood pressure assessed via clinical tests.

    Measured: Baseline and 6 months

  3. Change in Diastolic Blood Pressure

    Diastolic blood pressure assessed via clinical tests.

    Measured: Baseline and 6 months

  4. 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.

    Measured: 6 months

  5. 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.

    Measured: Baseline and 6 months

  6. 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.

    Measured: 6 months

  7. Change in Physical Activity Level.

    Change in physical activity level was assessed using the self-reported WHO Physical Activity Questionnaire

    Measured: Baseline and 6 months

  8. Change in Fruit and Vegetable Intake (Total Servings)

    Total mean servings per day of fruit and vegetables self report via electronic survey.

    Measured: Baseline and 6 months

  9. 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.

    Measured: Baseline and 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Aug 2017
  2. Study start30 Jul 2018
  3. Primary completion1 Dec 2021
  4. Study completion1 Dec 2021

Why it stopped: COVID-19 led to changes in study design and an early end to data collection.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Prevention
Allocation
Non-randomised
Intervention model
Parallel groups
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)
Enrolment
114 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03258723
Sponsor's protocol ID
2000020105
Other IDs
1K12HL138037-01, 1U54MD010711-01
Acronym
LIME
Status last verified
Feb 2024
First submitted
20 Aug 2017
Last updated
6 Feb 2024
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 41275221

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Lifestyle Intervention and Metformin in people with Diabetes, run by Yale University at 4 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 6 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Barbados, Puerto Rico, Trinidad and Tobago, Virgin Islands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Dec 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Hemoglobin A1c (HbA1c) (time frame: Baseline and 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03258723, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2024.

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