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NCT05975528

Effect of Sodium-glucose Cotransporter-2 Inhibitor in Cellular Senescence in Patients With Cardiovascular Diseases or Type 2 Diabetes

Status unknown Phase 4 Last updated 9 May 2024
What this trial tests

Phase 4 trial testing SGLT2 inhibitor in Diabetes Mellitus in 92 participants. Status unknown.

Timeline
1 June 2023
Primary endpoint
31 December 2025
31 December 2025

Quick facts

Lead sponsorYonsei University
PhasePhase 4
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingquadruple
Primary purposetreatment
Enrollment92
Start date1 June 2023
Primary completion31 December 2025
Estimated completion31 December 2025
Sites1 location across South Korea

Drugs / interventions tested

Conditions studied

Sponsor

Yonsei University

Who can join

Adults 50 to 85, any sex, with Diabetes Mellitus or Cellular Senescence. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Patients with type 2 diabetes (T2D) are more prevalent with aging-related comorbidities and frailty, which leads to a shorter life expectancy than non-diabetic individuals and that this excess mortality is largely attributable to cardiovascular causes. Therefore, since diabetes accelerates cellular senescence, attenuating aging process in patients with T2D is expected to reduce progression of comorbidities and eventually increase lifespan. According to previous studies, sodium-glucose cotransporter 2 (SGLT2) inhibitors have shown increased ketone bodies not only in blood but in various tissues including liver, kidney and colon, which could lead to beneficial effects in metabolic diseases. Especially, β-hydroxybutyrate (βHB) inhibits oxidative stress and reduces insulin resistance, which has a positive effect on preventing cardio-renal-metabolic diseases and aging process in patients with T2D. In this context, SGLT2 inhibitor can be a promising option to alleviate senescence process in patients with T2D. However, despite the accumulating evidence that support anti-senescent effect of SGLT2 inhibitor in preclinical models, no clinical study has investigated association between SGLT2 inhibitor use and senescence patients with T2D. Thus, the objective of this study is to determine whether the use of SGLT2 inhibitor is associated with anti-senescent effect in patients with T2D, which may expand the indications of SGLT2 inhibitor other than glycemic control.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Cellular senescence in age-related cardiovascular disease: past and future.
    Wu X, Zhou Q, Huang Y, Jiang W, et al · · 2025 · PMID 41602167 · DOI 10.3389/fragi.2025.1721744

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Other trials of SGLT2 inhibitor

Trials testing the same drug.

Other recruiting trials for Diabetes Mellitus

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Other Yonsei University trials

Trials by the same sponsor.

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Data sources for this page

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