Asymptomatic Bacteriuria, Urinalysis Abnormality at the Initiation of SGLT2 Inhibitors and UTI Risk

August 29, 2022 updated by: Erman Akkus, Trabzon Arakli Bayram Halil Public Hospital

Urinary Tract Infection Risk in Women With Asymptomatic Bacteriuria or Urinalysis Abnormality at the Initiation of SGLT2 Inhibitors

The SGLT2 inhibitors have changed the treatment of type 2 diabetes mellitus in recent years, especially in patients with cardiovascular or renal disease. However, the association between SGLT2 inhibitors and urinary tract infection (UTI) risk is controversial. Moreover, it is not known whether asymptomatic bacteriuria or urinalysis abnormality at the initiation of SGLT2 inhibitors are risk factors for UTI in women. There is not enough data to recommend or not to recommend for performing urinalysis or urine culture test before initiation of SGLT2 inhibitors. The aim of the study is to investigate the effect of asymptomatic bacteriuria or urinalysis abnormality at the initiation of SGLT2 inhibitors on UTI risk in a prospective cohort of women with type 2 diabetes mellitus.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

120

Contacts and Locations

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

Study Contact

Study Locations

  • Turkey
      • Trabzon, Turkey
        • Recruiting
        • Trabzon Araklı Bayram Halil Public Hospital
        • Contact:
          • Erman Akkus, MD

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

The female Type 2 Diabetes Mellitus patients followed and initiated SGLT2 inhibitors by an internal medicine specialist in a public hospital covering a district

Description

Inclusion Criteria:

  • Female
  • >18 years old
  • Type 2 Diabetes Mellitus
  • Initiated SGLT2 inhibitors
  • Available informed consent

Exclusion Criteria:

  • Having urinary tract or genital tract symptoms at the enrollment
  • Treated for urinary tract or genital tract infection in the last 3 months

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
positive for bacteriuria/ urinalysis abnormality
The patients who have any growth in urine culture or urinalysis abnormality at the initiation of SGLT2 inhibitor (dapagliflozin or empagliflozin)
Diagnostic test: urine culture and urinalysis
urine culture and urinalysis
negative for bacteriuria/ urinalysis abnormality
The patients who do not have growth in urine culture or do not have abnormality in urinalysis at the initiation of SGLT2 inhibitor (dapagliflozin or empagliflozin)
Diagnostic test: urine culture and urinalysis
urine culture and urinalysis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Urinary tract infection
Time Frame: 3 months
Number of participants with urinary tract infection - Any urinary tract infection treated or diagnosed by the physician clinically or by testing
3 months

Collaborators and Investigators

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

Sponsor

Trabzon Arakli Bayram Halil Public Hospital

Investigators

  • Study Chair: Erman Akkus, MD, Trabzon Arakli Bayram Halil Public Hospital

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)

February 15, 2022

Primary Completion (Anticipated)

November 1, 2022

Study Completion (Anticipated)

January 1, 2023

Study Registration Dates

First Submitted

August 26, 2022

First Submitted That Met QC Criteria

August 26, 2022

First Posted (Actual)

August 30, 2022

Study Record Updates

Last Update Posted (Actual)

September 1, 2022

Last Update Submitted That Met QC Criteria

August 29, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 6111449

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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