SGLT-2 and DPP-4 Inhibition, Subclinical Inflammation of the Genito-urinary Tract and Risk of Infections. (UTI-flog)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04735042|
Recruitment Status : Recruiting
First Posted : February 2, 2021
Last Update Posted : February 2, 2021
|Condition or disease||Intervention/treatment|
|Type 2 Diabetes Urinary Tract Infections||Drug: Empagliflozin / Linagliptin or Dapagliflozin/Saxagliptin Pill Drug: Empagliflozin or Dapagliflozin Pill|
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|
|Estimated Enrollment :||60 participants|
|Official Title:||Use of Combination Empagliflozin/Linagliptin or Dapagliflozin/Saxagliptin vs Empagliflozin or Dapagliflozin Alone, Subclinical Inflammation of the Genito-urinary Tract and Risk of Infections.|
|Actual Study Start Date :||October 7, 2020|
|Estimated Primary Completion Date :||October 7, 2021|
|Estimated Study Completion Date :||April 7, 2022|
SGLT2 and DPP-4 inhibitors
Patients undergoing SGLT2i and DPP4i.
Drug: Empagliflozin / Linagliptin or Dapagliflozin/Saxagliptin Pill
association between SGLT2-inhibitor and DPP4-inhibitor
Other Name: Glyxambi or Qtern
SGLT2 inhibitors only
Patients undergoing SGLT2i alone.
Drug: Empagliflozin or Dapagliflozin Pill
SGLT2-inhibitor: diabetic oral drug with diuretic properties.
Other Name: Jardiance or Forxiga
- Change from Baseline in metagenomic analysis based on rRNA 16S gene [ Time Frame: 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 [ Time Frame: 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
- Fasting glucose [ Time Frame: baseline and 12 week ]Fasting glucose measured in a fasting morning blood sample
- Glycated Haemoglobin [ Time Frame: baseline and 12 week ]HbA1c in a fasting measured in a morning blood sample
- Renal function [ Time Frame: 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 [ Time Frame: baseline and 12 week ]Measured by urinary albumin/creatinine ratio
- Total cholesterol [ Time Frame: baseline and 12 week ]Total cholesterol measured in a fasting morning blood sample
- HDL cholesterol [ Time Frame: baseline and 12 week ]HDL cholesterol measured in a fasting morning blood sample
- Triglycerides [ Time Frame: baseline and 12 week ]Triglycerides measured in a fasting morning blood sample
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04735042
|Contact: Anna Solini, MD, PhD||050993482 ext +firstname.lastname@example.org|
|University of Pisa||Recruiting|
|Pisa, Italy, 56125|
|Contact: Anna Solini, MD, PhD +39050993482 email@example.com|
|Principal Investigator:||Anna Solini, MD, PhD||University of Pisa|