Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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
Sponsor:
Information provided by (Responsible Party):
Anna Solini, University of Pisa

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.

Condition or disease Intervention/treatment
Type 2 Diabetes Urinary Tract Infections Drug: Empagliflozin / Linagliptin or Dapagliflozin/Saxagliptin Pill Drug: Empagliflozin or Dapagliflozin Pill

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.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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




Primary Outcome Measures :
  1. 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)

  2. 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


Secondary Outcome Measures :
  1. Fasting glucose [ Time Frame: baseline and 12 week ]
    Fasting glucose measured in a fasting morning blood sample

  2. Glycated Haemoglobin [ Time Frame: baseline and 12 week ]
    HbA1c in a fasting measured in a morning blood sample

  3. 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)

  4. Albumin excretion [ Time Frame: baseline and 12 week ]
    Measured by urinary albumin/creatinine ratio

  5. Total cholesterol [ Time Frame: baseline and 12 week ]
    Total cholesterol measured in a fasting morning blood sample

  6. HDL cholesterol [ Time Frame: baseline and 12 week ]
    HDL cholesterol measured in a fasting morning blood sample

  7. Triglycerides [ Time Frame: baseline and 12 week ]
    Triglycerides measured in a fasting morning blood sample


Biospecimen Retention:   Samples Without DNA
Serum Urine


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The study will consecutively enrolled 60 patients among those referring to the Departiment of Diabetes and Metabolic disease, Santa Chiara Hospital, Pisa.
Criteria

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).

Information from the National Library of Medicine

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


Contacts
Layout table for location contacts
Contact: Anna Solini, MD, PhD 050993482 ext +39 anna.solini@med.unipi.it

Locations
Layout table for location information
Italy
University of Pisa Recruiting
Pisa, Italy, 56125
Contact: Anna Solini, MD, PhD    +39050993482    anna.solini@med.unipi.it   
Sponsors and Collaborators
University of Pisa
Investigators
Layout table for investigator information
Principal Investigator: Anna Solini, MD, PhD University of Pisa
Publications:

Layout table for additonal information
Responsible Party: Anna Solini, Associate Professor, University of Pisa
ClinicalTrials.gov Identifier: NCT04735042    
Other Study ID Numbers: AS0005
First Posted: February 2, 2021    Key Record Dates
Last Update Posted: February 2, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Anna Solini, University of Pisa:
UTI
Type 2 Diabetes
SGLT2 inhibitors
DPP4 inhibitors
Additional relevant MeSH terms:
Layout table for MeSH terms
Infection
Communicable Diseases
Urinary Tract Infections
Diabetes Mellitus, Type 2
Inflammation
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pathologic Processes
Urologic Diseases
2-(3-(4-ethoxybenzyl)-4-chlorophenyl)-6-hydroxymethyltetrahydro-2H-pyran-3,4,5-triol
Empagliflozin
Linagliptin
Saxagliptin
Sodium-Glucose Transporter 2 Inhibitors
Molecular Mechanisms of Pharmacological Action
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors