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Prevalence of distal symmetrical polyneuropathy by Diabetes Prevention Program treatment group, diabetes status, duration of diabetes, and cumulative glycemic exposure

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posted on 2024-03-19, 19:34 authored by Christine G. Lee, Adam Ciarleglio, Sharon L. Edelstein, Jill P. Crandall, Dana Dabelea, Ronald B. Goldberg, Steven E. Kahn, William C. Knowler, Maxwell T. Ma, Neil H. White, William H. Herman

Objective: To assess associations between distal symmetric polyneuropathy (DSPN) and Diabetes Prevention Program (DPP) treatment groups, diabetes status or duration, and cumulative glycemic exposure approximately 21 years after DPP randomization.

Research Design and Methods: In DPP, 3,234 adults ≥25 years old at high risk for diabetes were randomized to intensive lifestyle (ILS), metformin, or placebo interventions to prevent diabetes. After DPP, 2,779 joined the DPP Outcomes Study (DPPOS). Open label metformin was continued, placebo was discontinued, ILS was provided as semi-annual group-based classes, and all were offered quarterly lifestyle classes. Symptoms and signs of DSPN were assessed in 1,792 participants at DPPOS Year 17. Multivariable logistic regression models evaluated DSPN associations with treatment group, diabetes status/duration, and cumulative glycemic exposure.

Results: Twenty-one years after DPP randomization, 66% had diabetes. DSPN prevalence did not differ by initial DPP treatment assignment (ILS 21.5%, metformin 21.5%, and placebo 21.9%). There was a significant interaction between treatment assignment to ILS and age (p<0.05) on DSPN. At DPPOS Year 17, the OR for DSPN comparing ILS to Placebo was 17.4% (95% CI 3.0% - 29.3%) lower with increasing 5-year age intervals. DSPN prevalence was slightly lower for those at risk for diabetes (19.6%) versus those with diabetes (22.7%) and was associated with longer diabetes duration and time-weighted HbA1c (p-values<0.001).

Conclusions: The likelihood of DSPN was similar across DPP treatment groups, while higher for those with diabetes, longer diabetes duration, and higher cumulative glycemic exposure. ILS may have long-term benefits on DSPN for older adults.

Funding

Research reported in this publication was supported by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) of the National Institutes of Health (NIH) under award numbers U01 DK048489, U01 DK048339, U01 DK048377, U01 DK048349, U01 DK048381, U01 DK048468, U01 DK048434, U01 DK048485, U01 DK048375, U01 DK048514, U01 DK048437, U01 DK048413, U01 DK048411, U01 DK048406, U01 DK048380, U01 DK048397, U01 DK048412, U01 DK048404, U01 DK048387, U01 DK048407, U01 DK048443, and U01 DK048400, by providing funding during DPP and DPPOS to the clinical centers and the Coordinating Center for the design and conduct of the study, and collection, management, analysis, and interpretation of the data. Funding was also provided by the National Institute of Child Health and Human Development, the National Institute on Aging, the National Eye Institute, the National Heart Lung and Blood Institute, the National Cancer Institute, the Office of Research on Women’s Health, the National Institute on Minority Health and Health Disparities, the Centers for Disease Control and Prevention, and the American Diabetes Association. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. The Southwestern American Indian Centers were supported directly by the NIDDK, including its Intramural Research Program, and the Indian Health Service. The General Clinical Research Center Program, National Center for Research Resources, and the Department of Veterans Affairs supported data collection at many of the clinical centers. Merck KGaA provided medication for DPPOS. DPP/DPPOS have also received donated materials, equipment, or medicines for concomitant conditions from Bristol-Myers Squibb, Parke-Davis, and LifeScan Inc., Health O Meter, Hoechst Marion Roussel, Inc., Merck-Medco Managed Care, Inc., Merck and Co., Nike Sports Marketing, Slim Fast Foods Co., and Quaker Oats Co. McKesson BioService

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