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

University of Pisa60 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Type 2 Diabetes Urinary Tract Infections

Interventions

Empagliflozin / Linagliptin or Dapagliflozin/Saxagliptin PillDRUG

association between SGLT2-inhibitor and DPP4-inhibitor

Empagliflozin or Dapagliflozin PillDRUG

SGLT2-inhibitor: diabetic oral drug with diuretic properties.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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).

Locations (1)

University of Pisa

Pisa, Pisa, Italy

Outcomes

Primary Outcomes

Change from Baseline in metagenomic analysis based on rRNA 16S gene

Metagenomic analysis based on rRNA 16S gene will be performed by Novogene on Illumina platform (Hong Kong, China)

Time frame: Each patients will be analyzed at baseline and after 12 weeks

Change from Baseline of total bacterial load

Absolute quantification of total bacterial load in the original sample using real-Time quantitative PCR

Time frame: Each patients will be analyzed at baseline and after 12 weeks