PRIME study - Preeclampsia Risk Identification, Mitigation, and prEvention in Type 2 Diabetes through Research and Mentorship - PROJECT SUMMARY/ABSTRACT Up to one-third of pregnant patients with type 2 diabetes (T2D) develop preeclampsia, a major cause of maternal morbidity and mortality and a risk factor for future cardiovascular disease (CVD). Offspring also face increased lifelong risks for obesity, diabetes, and CVD. Thus, preventing the development of preeclampsia offers the potential to improve health outcomes across generations. Current challenges include inadequate early risk identification, limited understanding of modifiable factors such as blood pressure (BP) and glycemic control during pregnancy, and insufficient evidence for effective prevention strategies, particularly in T2D. The ongoing R01-funded Continuous Glucose Monitoring for Management of T2D in Pregnancy (CGM2) trial offers a unique opportunity to address this knowledge gap, enrolling 564 diverse pregnant patients with T2D and collecting comprehensive longitudinal data on social drivers, BP and glycemic control, health behaviors, medication use, and biospecimens. Leveraging this cohort, the proposed Preeclampsia Risk Identification, Mitigation, and prEvention in T2D through Research and Mentorship (PRIME) study will integrate innovative investigation with a formal, structured mentoring platform to train early-stage clinician scientists aspiring to patient-oriented research (POR) careers in women’s health. Our scientific aims include: 1) To develop and validate a risk prediction model for preeclampsia in patients with T2D by integrating clinical and social factors and CVD biomarkers from early pregnancy, 2) To quantify the effect of BP and glycemic control during pregnancy on preeclampsia, and 3) To evaluate the impact of aspirin regimen (dose and timing) on preeclampsia prevention in pregnant patients with T2D. Furthermore, immersion of mentees in the CGM2 and PRIME trials will promote successful completion of the following mentoring aims: 1) Provide mentees hands-on training in POR including participant recruitment, intervention implementation, data collection and management, biospecimen processing, and multivariable modeling, building foundational skills for independent research in women’s health, 2) Advance mentees understanding and skills in human subjects protection, scientific writing, peer-review, and presenting and disseminating results, and 3) Teach mentees how to formulate novel research questions and build a robust network of interdisciplinary collaborators that advance their career development and empower them to independently design rigorous POR studies. It will also facilitate further career development of the PD/PI by 1) expanding methodologic expertise in artificial intelligence and machine learning, 2) building advanced dissemination and implementation science capacity 3) enhancing research mentorship and leadership skills. Successful completion of the proposed project will inspire the next generation of clinician-scientists in advancing women’s health research and inform future studies of targeted surveillance and interventions to prevent preeclampsia and CVD later in life, thus improving the lives of pregnant patients with T2D and their children.
