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

NCT ID: NCT05520684

Last Updated: 2022-09-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-02-15

Study Completion Date

2023-01-01

Brief Summary

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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.

Detailed Description

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Conditions

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Type2diabetes, SGLT2 Inhibitor, Urinary Tract Infection

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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)

urine culture and urinalysis

Intervention Type DIAGNOSTIC_TEST

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)

urine culture and urinalysis

Intervention Type DIAGNOSTIC_TEST

urine culture and urinalysis

Interventions

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urine culture and urinalysis

urine culture and urinalysis

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Trabzon Arakli Bayram Halil Public Hospital

OTHER

Sponsor Role lead

Responsible Party

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Erman Akkus

Internal Medicine Specialist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Erman Akkus, MD

Role: STUDY_CHAIR

Trabzon Arakli Bayram Halil Public Hospital

Locations

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Trabzon Araklı Bayram Halil Public Hospital

Trabzon, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Erman Akkus, MD

Role: CONTACT

Facility Contacts

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Erman Akkus, MD

Role: primary

Other Identifiers

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6111449

Identifier Type: -

Identifier Source: org_study_id

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