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

January 27, 2021 updated by: Anna Solini, University of Pisa

Use of Combination Empagliflozin/Linagliptin or Dapagliflozin/Saxagliptin vs Empagliflozin or Dapagliflozin Alone, Subclinical Inflammation of the Genito-urinary Tract and Risk of Infections.

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Pisa, Italy, 56125
        • Recruiting
        • University of Pisa
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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 Names:
  • Glyxambi or Qtern
SGLT2 inhibitors only
Patients undergoing SGLT2i alone.
Drug: Empagliflozin or Dapagliflozin Pill
SGLT2-inhibitor: diabetic oral drug with diuretic properties.
Other Names:
  • Jardiance or Forxiga

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Each patients will be analyzed at baseline and after 12 weeks
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
Each patients will be analyzed at baseline and after 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fasting glucose
Time Frame: baseline and 12 week
Fasting glucose measured in a fasting morning blood sample
baseline and 12 week
Glycated Haemoglobin
Time Frame: baseline and 12 week
HbA1c in a fasting measured in a morning blood sample
baseline and 12 week
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)
baseline and 12 week
Albumin excretion
Time Frame: baseline and 12 week
Measured by urinary albumin/creatinine ratio
baseline and 12 week
Total cholesterol
Time Frame: baseline and 12 week
Total cholesterol measured in a fasting morning blood sample
baseline and 12 week
HDL cholesterol
Time Frame: baseline and 12 week
HDL cholesterol measured in a fasting morning blood sample
baseline and 12 week
Triglycerides
Time Frame: baseline and 12 week
Triglycerides measured in a fasting morning blood sample
baseline and 12 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pisa

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 7, 2020

Primary Completion (ANTICIPATED)

October 7, 2021

Study Completion (ANTICIPATED)

April 7, 2022

Study Registration Dates

First Submitted

January 22, 2021

First Submitted That Met QC Criteria

January 27, 2021

First Posted (ACTUAL)

February 2, 2021

Study Record Updates

Last Update Posted (ACTUAL)

February 2, 2021

Last Update Submitted That Met QC Criteria

January 27, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AS0005

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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