Glycemia and Antibiotic Efficacy in Diabetic Recurrent UTIs

NCT07188935 | Completed DMC

• 1 other identifier: MustansiriyahU ,80 ,3/m9/2024
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

T2DM (Type 2 Diabetes Mellitus)

Outcome Measures

Primary Outcomes (2)

• 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.

  Up to 14 days after completion of antimicrobial therapy

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

  Day 30 after treatment initiation

Study Arms (2)

Non-diabetic patients with recurrent UTI

ACTIVE COMPARATOR

Non diabetic patients with recurrent UTI receiving treatment

Drug: ciprofloxacin 500 mg tablet

Diabetic patients with recurrent UTI

OTHER

Diabetic patients with recurrent UTI receiving treatments

Drug: ciprofloxacin 500 mg tablet

Interventions

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.

Diabetic patients with recurrent UTI; Non-diabetic patients with recurrent UTI

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Al-Mustansiriyah University: lead

Study Sites (1)

Al-Zahraa Teaching Hospital, Wasit, Iraq

Kut, Wasit Governorate, 52001, Iraq

Location

Related Links

• Related Info

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Ciprofloxacin; Tablets

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Dosage Forms; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Researcher

Study Record Dates

• First Submitted: September 1, 2025
• First Posted: September 23, 2025
• Study Start: October 30, 2024
• Primary Completion: June 20, 2025
• Study Completion: June 20, 2025
• Last Updated: September 24, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)