Luis A Rodríguez1, Simón Barquera2, Carlos A Aguilar-Salinas3, Jaime Sepúlveda-Amor4, Luz María Sánchez-Romero2, Edgar Denova-Gutiérrez2, Nydia Balderas2, Lizbeth Moreno-Loaeza5, Margaret A Handley6, Sanjay Basu7, Oliva López-Arellano8, Alberto Gallardo-Hernández8, Dean Schillinger9. 1. Department of Epidemiology & Biostatistics, University of California, San Francisco, San Francisco, CA, USA. Electronic address: Luis.Rodriguez@ucsf.edu. 2. Nutrition and Health Research Center, National Institute of Public Health, Cuernavaca, Mexico. 3. Division of Nutrition, Salvador Zubiran National Institute of Medical Sciences and Nutrition, Mexico City, Mexico. 4. Department of Epidemiology & Biostatistics, University of California, San Francisco, San Francisco, CA, USA; Institute for Global Health Sciences, University of California, San Francisco, San Francisco, CA, USA. 5. Research Unit on Metabolic Diseases, Salvador Zubiran National Institute of Medical Sciences and Nutrition, Mexico City, Mexico; Medical, Dental and Health Sciences, National Autonomous University of Mexico, Mexico City, Mexico. 6. Department of Epidemiology & Biostatistics, University of California, San Francisco, San Francisco, CA, USA; Division of General Internal Medicine at San Francisco General Hospital, University of California, San Francisco, San Francisco, CA, USA; UCSF Center for Vulnerable Populations, San Francisco General Hospital, San Francisco, CA, USA. 7. Department of Medicine, Stanford University, Palo Alto, CA, USA. 8. Ministry of Health, Mexico City, Mexico. 9. Division of General Internal Medicine at San Francisco General Hospital, University of California, San Francisco, San Francisco, CA, USA; UCSF Center for Vulnerable Populations, San Francisco General Hospital, San Francisco, CA, USA.
Abstract
INTRODUCTION: Type 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. METHODS: The "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. DISCUSSION: Findings 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 REGISTRATION: This trial is registered at Clinicaltrials.gov (NCT03194009).
RCT Entities:
INTRODUCTION:Type 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. METHODS: The "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. DISCUSSION: Findings 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 REGISTRATION: This trial is registered at Clinicaltrials.gov (NCT03194009).
Authors: X R Pan; G W Li; Y H Hu; J X Wang; W Y Yang; Z X An; Z X Hu; J Lin; J Z Xiao; H B Cao; P A Liu; X G Jiang; Y Y Jiang; J P Wang; H Zheng; H Zhang; P H Bennett; B V Howard Journal: Diabetes Care Date: 1997-04 Impact factor: 19.112
Authors: Andrea S Wallace; Hilary K Seligman; Terry C Davis; Dean Schillinger; Connie L Arnold; Betsy Bryant-Shilliday; Janet K Freburger; Darren A DeWalt Journal: Patient Educ Couns Date: 2009-01-23
Authors: Dennis Pérez; Patrick Van der Stuyft; Maríadel Carmen Zabala; Marta Castro; Pierre Lefèvre Journal: Implement Sci Date: 2016-07-08 Impact factor: 7.327