Type 2 Diabetes, Urinary Tract Infections
Conditions
Keywords
UTI, Type 2 Diabetes, SGLT2 inhibitors, DPP4 inhibitors
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 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.
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 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.
Interventions
DRUGEmpagliflozin / Linagliptin or Dapagliflozin/Saxagliptin Pill
association between SGLT2-inhibitor and DPP4-inhibitor
DRUGEmpagliflozin or Dapagliflozin Pill
SGLT2-inhibitor: diabetic oral drug with diuretic properties.
Sponsors
University of Pisa
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in metagenomic analysis based on rRNA 16S gene | Each patients will be analyzed at baseline and after 12 weeks | Metagenomic analysis based on rRNA 16S gene will be performed by Novogene on Illumina platform (Hong Kong, China) |
| Change from Baseline of total bacterial load | Each patients will be analyzed at baseline and after 12 weeks | Absolute quantification of total bacterial load in the original sample using real-Time quantitative PCR |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Renal function | baseline and 12 week | Using creatinine measured in a fasting morning blood sample and estimated by eGFR (calculated with the CDK-EPI formula) |
| Albumin excretion | baseline and 12 week | Measured by urinary albumin/creatinine ratio |
| Fasting glucose | baseline and 12 week | Fasting glucose measured in a fasting morning blood sample |
| HDL cholesterol | baseline and 12 week | HDL cholesterol measured in a fasting morning blood sample |
| Triglycerides | baseline and 12 week | Triglycerides measured in a fasting morning blood sample |
| Total cholesterol | baseline and 12 week | Total cholesterol measured in a fasting morning blood sample |
| Glycated Haemoglobin | baseline and 12 week | HbA1c in a fasting measured in a morning blood sample |
Countries
Italy
Outcome results
None listed