Diabetes Prevention With Lifestyle Intervention and Metformin Escalation

Phase 4 Terminated 114 enrolled Yale University National Heart, Lung, and Blood Institute (NHLBI) · collab National Institute on Minority Health and Health Disparities (NIMHD) · collab

Non-randomizedParallel-groupOpen-labelPrevention

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.

Timeline

Start: 2018-07-30
Primary completion: 2021-12-01
Completion: 2021-12-01

Outcome

Met primary endpoint

Stopped: “COVID-19 led to changes in study design and an early end to data collection.”

paper Reduction in HbA1c (6.19% to 5.67%, p < 0.0001) and weight (85.1 kg to 83.7 kg, p = 0.0149) was maintained at 12 months. PMID 41275221 ↗

registry analysis (superiority test); Intervention; p <0.0001; t-test, 2 sided NCT03258723 ↗

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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Metformin	Small molecule	850 mg	—