Status:
COMPLETED
SGLT-2 and DPP-4 Inhibition, Subclinical Inflammation of the Genito-urinary Tract and Risk of Infections.
Lead Sponsor:
University of Pisa
Conditions:
Type 2 Diabetes
Urinary Tract Infections
Eligibility:
All Genders
18-70 years
Brief Summary
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 ...
Detailed Description
The day of the study patients undergo a routine clinical evaluation. Whole blood samples will be collected from an antecubital vein to assess serum/plasma aliquots of 200 μl each (frozen at -80°C unti...
Eligibility Criteria
Inclusion
- Type 2 diabetes diagnosis
- Hb1Ac ≥ 7% and ≤ 9%
Exclusion
- Hb1Ac \> 9%
- current treatment with an SGLT2i or a DPP4i drugs, or in the prior 4 week
- irritating and/or obstructive urinary or genital symptoms
- menstrual cycle for women
- current antibiotic treatment or in the prior 4 weeks
- anatomical or functional abnormalities of the urinary tract (e.g. incontinence, neurological bladder, bladder prolapse).
Key Trial Info
Start Date :
October 7 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 7 2022
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04735042
Start Date
October 7 2020
End Date
April 7 2022
Last Update
July 18 2025
Active Locations (1)
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1
University of Pisa
Pisa, Pisa, Italy, 56125