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

University of Pisa

Status: Completed

Conditions: Urinary Tract Infections; Type 2 Diabetes

Treatments: Drug: Empagliflozin / Linagliptin or Dapagliflozin/Saxagliptin Pill; Drug: Empagliflozin or Dapagliflozin Pill

Study type: Observational

Funder types: Other

Identifiers

NCT04735042

AS0005

Details and patient eligibility

About

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.

Full 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 until required for quantitation) for evaluation of biochemical parameters (fasting glucose, HbA1c, lipid profile, serum creatinine, uric acid, electrolytes, liver function enzymes, albumin).

A mid-stream first urine in the morning sample will be collected into a sterile container. 50 ml of urine will be immediately transferred into a sterile falcon and centrifugated at 4500 rpm for 10 min. After removal of the supernatant and addition of 10 ml of PBS or sterile physiological solution, the sample will be further centrifugated at 4500 rpm for 10 min. The supernatant will be removed and the pellet stored in a falcon at -80°C.

Genomic DNA will be extracted throw Qiamp DNA mini kit (QIAGEN) and quantified using spectrophotometric assay.

Enrollment: 60 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Type 2 diabetes diagnosis
• Hb1Ac ≥ 7% and ≤ 9%

Exclusion criteria

• 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).

Trial design

60 participants in 2 patient groups

SGLT2 and DPP-4 inhibitors

Description:

Patients undergoing SGLT2i and DPP4i.

Treatment:

Drug: Empagliflozin / Linagliptin or Dapagliflozin/Saxagliptin Pill

SGLT2 inhibitors only

Description:

Patients undergoing SGLT2i alone.

Treatment:

Drug: Empagliflozin or Dapagliflozin Pill