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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
| |
| 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| urine culture and urinalysis | Diagnostic Test | urine culture and urinalysis |
|
| Measure | Description | Time Frame |
|---|---|---|
| Urinary tract infection | Number of participants with urinary tract infection - Any urinary tract infection treated or diagnosed by the physician clinically or by testing | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
Female
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The female Type 2 Diabetes Mellitus patients followed and initiated SGLT2 inhibitors by an internal medicine specialist in a public hospital covering a district
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Erman Akkus, MD | Contact | erman_akkus@yahoo.com |
| Name | Affiliation | Role |
|---|---|---|
| Erman Akkus, MD | Trabzon Arakli Bayram Halil Public Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Trabzon Araklı Bayram Halil Public Hospital | Recruiting | Trabzon | Turkey (Türkiye) |
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| ID | Term |
|---|---|
| D014552 | Urinary Tract Infections |
| ID | Term |
|---|---|
| D007239 | Infections |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D016482 | Urinalysis |
| ID | Term |
|---|---|
| D019963 | Clinical Chemistry Tests |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D003950 | Diagnostic Techniques, Urological |
| D008919 | Investigative Techniques |