| CTRI Number |
CTRI/2026/02/103847 [Registered on: 13/02/2026] Trial Registered Prospectively |
| Last Modified On: |
13/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Study on urine infections in patients taking SGLT2 medicine for diabetes. |
|
Scientific Title of Study
|
Assessment of Knowledge Attitude and Practice towards Urinary tract infection in patients receiving SGLT2 inhibitors A Cross-Sectional Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mustakim M Mansuri |
| Designation |
Associate Professor |
| Affiliation |
L. M. College of Pharmacy |
| Address |
Department of Pharmacology, L. M. College of Pharmacy, Navrangpura, Ahmedabad
Department of Pharmacology, L. M. College of Pharmacy, Navrangpura, Ahmedabad 380009
Ahmadabad
GUJARAT
380009
India |
| Phone |
9426323824 |
| Fax |
|
| Email |
mustakim.mansuri@lmcp.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mustakim M Mansuri |
| Designation |
Associate Professor |
| Affiliation |
L. M. College of Pharmacy |
| Address |
Department of Pharmacology, L. M. College of Pharmacy, Navrangpura, Ahmedabad
Department of Pharmacology, L. M. College of Pharmacy, Navrangpura, Ahmedabad 380009
Ahmadabad
GUJARAT
380009
India |
| Phone |
9426323824 |
| Fax |
|
| Email |
mustakim.mansuri@lmcp.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mustakim M Mansuri |
| Designation |
Associate Professor |
| Affiliation |
L. M. College of Pharmacy |
| Address |
Department of Pharmacology, L. M. College of Pharmacy, Navrangpura, Ahmedabad
Department of Pharmacology, L. M. College of Pharmacy, Navrangpura, Ahmedabad 380009
Ahmadabad
GUJARAT
380009
India |
| Phone |
9426323824 |
| Fax |
|
| Email |
mustakim.mansuri@lmcp.ac.in |
|
|
Source of Monetary or Material Support
|
| L. M. College of Pharmacy, Navrangpura, Ahmedabad 380009, Gujarat, India |
|
|
Primary Sponsor
|
| Name |
L M College of Pharmacy |
| Address |
L. M. College of Pharmacy, Navrangpura, Ahmedabad 380009, Gujarat, India |
| Type of Sponsor |
Other [Academic and Research Institution] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Jigar Patel |
Sarthi Hospital |
Counseling Room-Pharmacy, 302, central square, near KB ROYAL PHOENIX, behind satyamev hospital, Chandkheda, Ahmedabad, Gujarat 382424
Ahmadabad
GUJARAT |
9727737111
dr.jigar12@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE L M COLLEGE OF PHARMACY LMIEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Day(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Adults aged 18 years and above diagnosed with Type2 Diabetes Mwllitus (T2DM).
Patient who are currently prescribed SGLT2 inhibitor (such as dapagliflozin, empagliflozin, canagliflozin, or other), either as monotherapy or combination with other antidiabetic medication.
Patients who are clinically stable and ambulatory at the time of recruitment.
Patients who are able to read/understand the study questionnaire in English or local language.
who are willing to provide written informed consent for participation |
|
| ExclusionCriteria |
| Details |
Patients with a documented history of recurrent urinary tract infections (more than three episodes in the past year) prior to initiation of SGLT2
Patients with a known anatomical abnormality of the urinary tract (e.g., vesicoureteral reflux, urethral stricture, neurogenic bladder).
Patients with chronic kidney disease stage 4 or 5
Patients with severe hepatic impairment or decompensated liver disease.
Pregnant women, lactating mothers, or women planning pregnancy during the study period.
Patients who are immunocompromised (HIV/AIDS, malignancy, or on long-term corticosteroids or immunosuppressants)
Patients with indwelling urinary catheters or who have undergone recent urological surgery.
Patients who are cognitively impaired, mentally unstable, or unable to complete the questionnaire reliably |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Collect data analyse and improve knowledge regarding SGLT2 inhibitors and urinary tract infection and thereby improving attitude and practice. |
data will be collected once only i.e. baseline as the study design is cross-sectional observational study . Data pertaining to knowledge, attitude and practice regarding SGLT2 inhibitors and urinary tract infection will be collected using validated questionnaire. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NA |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
24/02/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Diabetes mellitus, particularly Type 2 (T2DM), is a chronic disorder marked by hyperglycemia from insulin defects, leading to microvascular and macrovascular complications if unmEffective control via lifestyle and pharmacotherapy is crucial. SGLT2 inhibitors (dapagliflozin, empagliflozin, canagliflozin, ertugliflozin) lower glucose by blocking renal reabsorption, promoting urinary excretion. They offer cardiovascular/renal increase UTI risk by creating a glucose-rich urine environment favoring microbial growth especially in women and elderly diabetics, potentially progressing to pyelonephritis. Hence Study aim to Assessment of Knowledge, Attitude and Practice towards Urinary Tract Infection in patients receiving SGLT2 inhibitors: A Cross-Sectional Study with primary objective to Assess KAP on UTI prevention, detection, and management in SGLT2i patients and Secondary objectives to evaluate correlations between knowledge, attitude, and practice scores. Patients often lack awareness of SGLT2i-related UTIs, symptoms, prevention (hydration, hygiene), and need for prompt reporting—leading to delays and complications. Even with kpoor attitudes and practices (e.g., ignoring symptoms) persist, as awareness alone rarely drives behavior change. This KAP study at L.M. College of Pharmacy identifies gaps for better outcomes. |