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

> **NIH NIH F32** · MASSACHUSETTS GENERAL HOSPITAL · 2020 · $75,930

## 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 organization:** MASSACHUSETTS GENERAL HOSPITAL
- **Principal Investigator:** Sara Jane Cromer
- **Activity code:** F32 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $75,930
- **Award type:** 1
- **Project period:** 2021-07-01 → 2022-09-22

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10138197

## Citation

> US National Institutes of Health, RePORTER application 10138197, The Effect of Socioeconomic Status on Outcomes in Type 2 Diabetes Clinical Trials (1F32DK127545-01). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10138197. Licensed CC0.

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