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Randomized Controlled Trial
. 2024 May 1;47(5):810-817.
doi: 10.2337/dc23-2009.

Prevalence of Distal Symmetrical Polyneuropathy by Diabetes Prevention Program Treatment Group, Diabetes Status, Duration of Diabetes, and Cumulative Glycemic Exposure

Christine G Lee  1 , Adam Ciarleglio  2 , Sharon L Edelstein  2 , Jill P Crandall  3 , Dana Dabelea  4 , Ronald B Goldberg  5 , Steven E Kahn  6 , William C Knowler  2 , Maxwell T Ma  6 , Neil H White  7 , William H Herman  8 ; Diabetes Prevention Program Research Group
Collaborators, Affiliations
Randomized Controlled Trial

Prevalence of Distal Symmetrical Polyneuropathy by Diabetes Prevention Program Treatment Group, Diabetes Status, Duration of Diabetes, and Cumulative Glycemic Exposure

Christine G Lee et al. Diabetes Care. .

Abstract

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 the DPP, 3,234 adults ≥25 years old at high risk for diabetes were randomized to an intensive lifestyle (ILS), metformin, or placebo intervention to prevent diabetes. After the DPP ended, 2,779 joined the Diabetes Prevention Program Outcomes Study (DPPOS). Open-label metformin was continued, placebo was discontinued, ILS was provided in the form of semiannual group-based classes, and all participants were offered quarterly lifestyle classes. Symptoms and signs of DSPN were assessed in 1,792 participants at DPPOS year 17. Multivariable logistic regression models were used to evaluate DSPN associations with treatment group, diabetes status/duration, and cumulative glycemic exposure.

Results: At 21 years after DPP randomization, 66% of subjects 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 odds ratio for DSPN in comparison with ILS with 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 but higher for those with diabetes, longer diabetes duration, and higher cumulative glycemic exposure. ILS may have long-term benefits on DSPN for older adults.

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Conflict of interest statement

Duality of Interest. C.G.L. was an employee in the Division of Diabetes, Endocrinology and Metabolic Diseases at the NIDDK at the NIH at the time this research was conducted and is now an employee of Pfizer. No other potential conflicts of interest relevant to this article were reported.

Figures

None
Graphical abstract
Figure 1
Figure 1
Age-dependent OR of DSPN for ILS vs. placebo (left) and metformin vs. placebo (right) and corresponding 95% confidence bands. Black tick marks along horizontal axes show data density. ILS, intensive lifestyle intervention.
See this image and copyright information in PMC

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