SGLT-2 and DPP-4 Inhibition, Subclinical Inflammation of the Genito-urinary Tract and Risk of Infections.

Sponsor
University of Pisa
Study ID
NCT04735042
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

In this observational study, 60 subjects with type 2 diabetes (T2D) and eligible, as per good clinical practice, for therapy with SGLT-2 inhibitor, will be randomized to receive a SGLT-2 inhibitor or a fixed dose combination of SGLT-2 inhibitor with a DPP4-inihibitor for 12 weeks. Measures will be performed at baseline and after 12 weeks of treatment, as per good clinical practice.

Key Dates

Start date
Oct 7, 2020
Status verified
Jul 2025
Primary completion
Oct 7, 2021
Completion
Apr 7, 2022

Study Design

Enrollment
60 participants (actual)

Arms

  • Arm: SGLT2 and DPP-4 inhibitors
    Patients undergoing SGLT2i and DPP4i.
  • Arm: SGLT2 inhibitors only
    Patients undergoing SGLT2i alone.

Primary Outcome Measure

Change from Baseline in metagenomic analysis based on rRNA 16S gene [ Time Frame: Each patients will be analyzed at baseline and after 12 weeks ]

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