# 2/22 Limited Competition for the Continuation of the Diabetes Prevention Program Outcomes Study (DPPOS) - Clinical Center

> **NIH NIH U01** · UNIVERSITY OF CHICAGO · 2021 · $1

## Abstract

ABSTRACT
Abnormal regulation of glycemia (“dysglycemia”) has a very long time course, from the earliest stage of pre-
diabetes, to the onset of Type 2 diabetes (T2D), to the development of clinically detectable microvascular
changes and measurable atherosclerosis, to clinically manifest complications with attendant morbidity and
mortality. The Diabetes Prevention Program (DPP) focused on the pre-diabetes stage of dysglycemia and
demonstrated powerful beneficial effects of lifestyle intervention (ILS) and metformin (MET), compared with
placebo (PLBO), in preventing or delaying the onset of T2D over a 3-year period in a high-risk population
(n=3234). The DPP also investigated and described the interventions, phenotypic and genotypic risk factors
associated with T2D development, the effects of the interventions in the setting of these risk factors, the health
economic implications of T2D prevention, and other outcomes of interest. Based on these results, the DPP
lifestyle program has been widely implemented. The DPP Outcomes Study (DPPOS) has explored the longer-
term effects of T2D prevention in the DPP cohort, bridging the period between pre-diabetes and T2D, and has
examined outcomes that required more time to develop than the 3-years of DPP. DPPOS showed longer-term
salutary effects of the original interventions on T2D prevention and on cardiovascular disease (CVD) risk
factors. The risk for microvascular disease was significantly greater in subjects who developed T2D and
increased with longer duration and higher hemoglobin A1c (HbA1c). There were no significant differences by
treatment group in the prevalence of the aggregate microvascular outcome; however, compared with PLBO and
MET, ILS significantly reduced the risk of microvascular disease among women and those with HbA1c ≥6.5%.
During the one-year extension of DPPOS Phase 3, we will maintain and continue to follow the well-
characterized and valuable DPPOS cohort, and collect measurements of outcomes as described in the
protocol. We will 1) perform new analyses to characterize the heterogeneous course of dysglycemia and its
long-term complications and factors that define susceptibility or resistance to diabetes, its complications, and
common chronic conditions of aging, and 2) explore the factors associated with participant retention, adherence
to the protocol and completion of measurements, and determine if alternative methods can be implemented to
improve retention and adherence and to expand data collection. These aims will provide important insights into
prediabetes and diabetes and their long-term outcomes and could serve the potential further study of the
DPPOS cohort.

## Key facts

- **NIH application ID:** 10156159
- **Project number:** 2U01DK048381-28
- **Recipient organization:** UNIVERSITY OF CHICAGO
- **Principal Investigator:** DAVID A EHRMANN
- **Activity code:** U01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $1
- **Award type:** 2
- **Project period:** 1994-08-20 → 2023-01-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10156159

## Citation

> US National Institutes of Health, RePORTER application 10156159, 2/22 Limited Competition for the Continuation of the Diabetes Prevention Program Outcomes Study (DPPOS) - Clinical Center (2U01DK048381-28). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10156159. Licensed CC0.

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