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Completed

NCT Number: NCT07188935

Glycemia and Antibiotic Efficacy in Diabetic Recurrent UTIs

This study looked at how blood sugar control affects treatment of repeated urinary tract infections (UTIs) in people with type 2 diabetes. Ninety-nine patients at Al-Zahraa Teaching Hospital in Iraq were included. Some patients had good blood sugar control, while others did not. All were treated with antibiotics, and doctors checked if the infection was cured after 14 days and if it came back within 30 days. The study helps show how diabetes management can affect recovery from UTIs and the chance of infection returning.

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Key information

Conditions

T2DM (Type 2 Diabetes Mellitus) Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Al-Zahraa Teaching Hospital, Wasit, Iraq

Kut, Wasit Governorate, 52001, Iraq

About this study

Recurrent urinary tract infections (rUTIs) are a frequent complication among patients with type 2 diabetes mellitus (T2DM), associated with impaired immune function, glycosuria, and increased risk of antimicrobial resistance. While UTIs are common in both diabetic and non-diabetic patients, recurrence rates and treatment failures are higher in T2DM. Few prospective studies have evaluated the effect of glycemic control on antimicrobial response in this population.

This prospective comparative study enrolled 99 patients with recurrent UTIs, including 58 with T2DM, at Al-Zahraa Teaching Hospital, Wasit Province, Iraq. Patients with diabetes were stratified into groups based on glycemic control (good vs. poor). Antimicrobial therapy was administered according to hospital guidelines, and treatment response was evaluated after 14 days (clinical cure). Patients were followed for 30 days to monitor recurrence.

The primary objective was to assess whether glycemic status influences antimicrobial treatment outcomes in patients with rUTIs. Secondary objectives included evaluating recurrence rates and identifying potential risk factors for treatment failure. Findings from this study highlight the importance of optimizing glycemic control as part of the overall management of recurrent UTIs in patients with T2DM.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients age >18 years, both sex
  • Patient with known history of T2DM at least 1 year
  • Patients diagnosed with rUTI according to the positive GUE as in practice guideline
  • Patients with different glycemic status according to the HbA1c level, and on different treatment for T2DM accordingly.
  • Patients with non-diabetic rUTI as active comparator.
  • Patients who had the ability to communicate to answer study questionnaire.

Exclusion criteria

  • Type 1 diabetic patients on insulin therapy were excluded.
  • T2DM Patients who were using Sodium-glucose co-transporter-2 inhibitors (SGLT-2) (because of their renal -related side effect).
  • Patients who received any antimicrobial treatment within the last 72 hours of their enrollment.
  • Women patients with recurrent vaginitis or urinary incontinence.
  • Men patients with BPH or over flow incontinence ( as a cause for r UTI).
  • Patients with chronic disease other than T2DM that may cause rUTI ( eg. CKD, Spinal cord injury. kidney stone).
  • Pregnancy and lactation

Treatment and study plan

ciprofloxacin 500 mg tablet

Drug

Administration of oral ciprofloxacin 500 mg twice daily for 7-14 days for the treatment of recurrent urinary tract infections in patients with type 2 diabetes mellitus, following local and international guidelines.

Primary outcomes

  1. treatment success will be defined as simultaneous absence of symptoms and GUE showing <5 pus cells/HPF and MARS-10 score ≥8. Unit of measure: % of participants meeting all criteria.

    Time frame: Up to 14 days after completion of antimicrobial therapy

  2. treatment success will be defined as simultaneous absence of symptoms and GUE showing <5 pus cells/HPF after 30 days of treatment initiation

    Time frame: Day 30 after treatment initiation

Sponsors and collaborators

Lead sponsor

Al-Mustansiriyah University

Other

Registry information

Official study title

Effect of Glycemic Status on Antimicrobial Response in T2DM Patients With Recurrent UTI, Prospective Comparative Study

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 23, 2025
Registry last updated
Sep 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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