944-P: Impact of Salt Reduction on Nocturia in Patients with Type 2 Diabetes—The TOP-STAR Study

Title: Impact of Salt Reduction on Nocturia in Type 2 Diabetes Patients: The TOP-STAR Study

Introduction & Objective: This study addresses the prevalence of nocturia in type 2 diabetes patients, a condition often exacerbated by SGLT2 inhibitors. Recognizing the potential role of dietary salt in nocturnal urination, the study aims to evaluate the effect of salt reduction instruction combined with tofogliflozin therapy. We hypothesize that dietary salt restriction, alongside SGLT2 inhibitor use, may alleviate nocturia in this population.

Methods: The TOP-STAR study is a multi-center, open-label, randomized trial involving 80 patients with type 2 diabetes experiencing nocturia. Participants were randomly assigned to two groups: one receiving standard care with tofogliflozin therapy, and the other receiving additional salt reduction instructions. The primary outcome measured was the change in frequency of nocturnal urination over 12 weeks. Secondary outcomes included nocturnal urine volume and overall quality of life assessments.

Results: as follows; the average nocturia frequencies at baseline and 12 weeks were 1.3 [0.9-2.1] and 1.1 [0.5-1.9] vs and 1.5 [0.7-2.1] vs 1.4 [1.0-1.7] times per day respectively. The changes in nocturnal urine volume were -39.2 [-146.7-81.6] vs -71.7 [-218.3-78.4] mL (p=0.29). The changes in diurnal urine volume were 337.1 [41.6-513.4] vs 289.2 [7.2-490.8] mL (p=0.77).

Conclusion: Our findings indicate no significant superiority of salt restriction in reducing the frequency of nocturnal urination. However, tofogliflozin therapy was not associated with an increase in nocturia frequency and may contribute to a decrease in nocturnal urine volume. Notably, a subset of patients adhering strictly to salt reduction showed a trend towards reduced nocturia, suggesting potential individual benefits.