Ignite Creation Date:
2024-05-06 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 1:55 PM
Study NCT ID:
NCT04735042
Status:
UNKNOWN
Last Update Posted:
2021-02-02
First Post:
2021-01-22
Brief Title:
SGLT-2 and DPP-4 Inhibition Subclinical Inflammation of the Genito-urinary Tract and Risk of Infections
Sponsor:
University of Pisa
Organization:
University of Pisa
Study Overview
Official Title:
Use of Combination EmpagliflozinLinagliptin or DapagliflozinSaxagliptin vs Empagliflozin or Dapagliflozin Alone Subclinical Inflammation of the Genito-urinary Tract and Risk of Infections
Status:
UNKNOWN
Status Verified Date:
2021-01
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
UTI-flog
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 serumplasma aliquots of 200 μl each frozen at -80C 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 -80C
Genomic DNA will be extracted throw Qiamp DNA mini kit QIAGEN and quantified using spectrophotometric assay
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 -80C
Genomic DNA will be extracted throw Qiamp DNA mini kit QIAGEN and quantified using spectrophotometric assay
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None