The Effect of Socioeconomic Status on Outcomes in Type 2 Diabetes Clinical Trials

NIH RePORTER · NIH · F32 · $75,930 · view on reporter.nih.gov ↗

Abstract

PROJECT ABSTRACT Type 2 diabetes (T2DM) affects more than 10% of US adults, and low socioeconomic status (SES) is strongly associated with incidence, prevalence, and morbidity from T2DM, as well as with complications of therapy. Despite this known association, the effect of SES on outcomes within clinical trials for T2DM is rarely evaluated. It is critical to study this question in order to understand how currently available therapies perform in low SES groups and to prioritize interventions for implementation in high-risk populations. This proposal aims to analyze the role of SES in two landmark trials evaluating the effect of lifestyle change or glycemic management for T2DM on key macrovascular outcomes. Action for Health in Diabetes (Look AHEAD) studied an intensive lifestyle intervention with the goal of weight loss, while Action to Control Cardiovascular Risk in Diabetes (ACCORD) studied intensive vs conservative glycemic targets. In Aim 1, the candidate will compare the rates of the primary macrovascular outcome of each trial, stratified by SES and treatment arm. In Aim 2, the candidate will evaluate intermediate outcomes, such as weight loss and glycemic control, and adverse treatment outcomes such as hypoglycemia, again stratified by SES and treatment arm. Significant findings from these analyses will guide clinical management of patients of low SES with T2DM. The candidate will complete the proposed work under the mentorship of Dr. Deborah Wexler and Dr. James Meigs. Dr. Wexler is an internationally recognized expert in pharmacotherapy for T2DM and holds leadership roles on the REAL HEALTH-Diabetes trial of a lifestyle intervention and the GRADE trial comparing pharmacotherapies for T2DM. Similarly, Dr. Meigs is an internationally recognized expert in epidemiology of diabetes and cardiovascular disease with prior work focusing on socioeconomic disparities in metabolic disease. In addition to this direct mentorship, the candidate will pursue both formal coursework and regular engagement in collaborative research meetings related to both clinical diabetes and epidemiology. This project will also facilitate development of skills in the areas of study design, working with large data sets, statistical analysis, and use of statistical software. The divisions of Endocrinology, Diabetes, and Metabolism and General Internal Medicine at the Massachusetts General Hospital will provide an unparalleled environment for trainee learning. Further, the direct mentorship provided by Dr. Wexler and Dr. Meigs will ensure a broad base of expertise and training in clinical research methods for T2DM. This application represents a comprehensive plan to identify important factors in caring for people with T2DM and low SES and to prepare the candidate to apply for a career development award to continue her training and become an independent clinical investigator.

Key facts

NIH application ID
10138197
Project number
1F32DK127545-01
Recipient
MASSACHUSETTS GENERAL HOSPITAL
Principal Investigator
Sara Jane Cromer
Activity code
F32
Funding institute
NIH
Fiscal year
2020
Award amount
$75,930
Award type
1
Project period
2021-07-01 → 2022-09-22