1. Design of a cluster-randomized trial of the effectiveness and cost-effectiveness of metformin on prevention of type 2 diabetes among prediabetic Mexican adults (the PRuDENTE initiative of Mexico City)
- Author
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Rodríguez, Luis A, Barquera, Simón, Aguilar-Salinas, Carlos A, Sepúlveda-Amor, Jaime, Sánchez-Romero, Luz María, Denova-Gutiérrez, Edgar, Balderas, Nydia, Moreno-Loaeza, Lizbeth, Handley, Margaret A, Basu, Sanjay, López-Arellano, Oliva, Gallardo-Hernández, Alberto, and Schillinger, Dean
- Subjects
Health Services and Systems ,Biomedical and Clinical Sciences ,Clinical Sciences ,Health Sciences ,Obesity ,Clinical Research ,Comparative Effectiveness Research ,Diabetes ,Clinical Trials and Supportive Activities ,Dissemination and Implementation Research ,Behavioral and Social Science ,Women's Health ,Health Disparities ,Nutrition ,Prevention ,Minority Health ,Cost Effectiveness Research ,Health Services ,3.1 Primary prevention interventions to modify behaviours or promote wellbeing ,Metabolic and endocrine ,Good Health and Well Being ,Adult ,Aged ,Cost-Benefit Analysis ,Diabetes Mellitus ,Type 2 ,Humans ,Metformin ,Mexico ,Middle Aged ,Prediabetic State ,Type 2 diabetes ,Cluster trial ,Research protocol ,Implementation evaluation ,Medical and Health Sciences ,General Clinical Medicine ,Public Health ,Biomedical and clinical sciences ,Health sciences - Abstract
IntroductionType 2 diabetes (T2D) is a global epidemic, and nations are struggling to implement effective healthcare strategies to reduce the burden. While efficacy studies demonstrate that metformin can reduce incident T2D by half among younger, obese adults with prediabetes, its real-world effectiveness are understudied, and its use for T2D prevention in primary care is low. We describe the design of a pragmatic trial to evaluate the incremental effectiveness of metformin, as an adjunct to a simple lifestyle counseling.MethodsThe "Prevención de la Diabetes con Ejercicio, Nutrición y Tratamiento" [Diabetes Prevention with Exercise, Nutrition and Treatment; PRuDENTE, (Spanish acronym)] is a cluster-randomized trial in Mexico City's public primary healthcare system. The study randomly assigns 51 clinics to deliver one of two interventions for 36 months: 1) lifestyle only; 2) lifestyle plus metformin, to 3060 patients ages 30-65 with impaired fasting glucose and obesity. The primary endpoint is incident T2D (fasting glucose ≥126 mg/dL, or HbA1c ≥6.5%). We will also measure a range of implementation-related process outcomes at the clinic-, clinician- and patient-levels to inform interpretations of effectiveness and enable efforts to refine, adapt, adopt and disseminate the model. We will also estimate the cost-effectiveness of metformin as an adjunct to lifestyle counseling in Mexico.DiscussionFindings from this pragmatic trial will generate new translational knowledge in Mexico and beyond, both with respect to metformin's real-world effectiveness among an 'at-risk' population, and uncovering facilitators and barriers to the reach, adoption and implementation of metformin preventive therapy in public primary care settings.Trial registrationThis trial is registered at Clinicaltrials.gov (NCT03194009).
- Published
- 2020