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Proposal 1331

Title of the Proposed Research

Impact of baseline diabetes and obesity statuses on outcomes post-ischemic stroke.

Lead Researcher

Colleen Bauza


Medical University of South Carolina in Public Health Sciences

Funding Source


Potential Conflicts of Interest


Data Sharing Agreement Date

9 June 2016

Lay Summary

Background of the Project

Obesity and diabetes have continued to increase in prevalence since 1980 in the United States. Based on the 2011-2012 National Health and Nutrition Examination Survey (NHANES), 68.5% of US adults were considered overweight or obese, and 34.9% were obese. According to the American Diabetes Association, 29.1 million (9.3%) Americans had diabetes in 2012. While diabetes is considered a group of diseases marked by high levels of blood glucose resulting from issues in how insulin is produced and/or works, Type II diabetes (non-insulin dependent diabetes) accounts for 95% of all diagnosed cases of diabetes.

Obesity and diabetes afflict a significant number of Americans and increase their risk of multiple negative health-related outcomes. Yet, both obesity and type II diabetes are considered to be preventable and modifiable risk factors. While it is well known that obesity and diabetes are associated with an increased risk of ischemic stroke, there is a lack of consensus regarding the impact of obesity and diabetes on stroke related outcomes. The Prevention Regimen for Effectively avoiding Second Stroke (PRoFESS) trial provides the ideal large cohort in which to investigate the relationship of obesity and diabetes with post primary stroke outcomes.

Objective: To describe the effect that obesity and diabetes have on post stroke outcomes. Primary aims:
Aim 1: To describe the relationship between obesity, diabetes, and the combination on post-stroke mortality.
Aim 2: To describe the relationship between obesity, diabetes, and the combination on recurrent vascular events post-stroke.
Aim 3: To describe the relationship between obesity, diabetes, and the combination on re-hospitalization post-stroke.

The proposed study follows a prospective cohort design where the cohort of ischemic stroke subjects enrolled in the PRoFESS trial was prospectively followed for approximately four years to obtain outcomes. Time to mortality, time to first vascular event post-stroke, and time to first re-hospitalization post-stroke will be explored via Cox-proportional hazards modeling for all aims.

There is a paucity of information concerning the joint impact of obesity and diabetes on stroke-related outcomes; this research will be able to build upon existing knowledge and extend our understanding of factors influencing the post stroke trajectory. Results from this study will provide evidence that post-stroke outcomes are associated with obesity and diabetes. Moreover, this research will suggest that reducing the burden of these risk factors may diminish poor outcomes following stroke.

Study Data Provided

Study BI-9.159: PRoFESS - Prevention Regimen For Effectively Avoiding Second Strokes

Statistical Analysis Plan

Publication Citation

The publication citation will be added after the research is published.

Summary Results

Results summary or link will be posted when available.