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NCT06148259 Clinical Trial

SGLT Inhibitors Versus DDP4 Inhibitors and Prostate in Patient With Diabetes

Diabetes Mellitus Clinical Trial

Official title:
Comparison of Two Novel Anti Diabetes Medications Classes as Regard Prostate Symptoms in Patient With Diabetes

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT06148259
Other study ID # N-136-2023
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 12, 2021
Est. completion date September 13, 2022

Study information
Verified date November 2023
Source Kasr El Aini Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The study aims to compare the effect of two different classes of anti- diabetes medications on prostate volume and symptoms in elderly patients with diabetes mellitus

Description:

The study aims to compare the effect of two different classes of anti- diabetes medications on prostate volume and symptoms in elderly patients with diabetes mellitus The study compares sodium glucose cotransporter 2 inhibitors to Dipeptidyl peptidase 4 inhibitors in elderly patients with type 2 diabetes mellitus

Recruitment information / eligibility
Status Completed
Enrollment 57
Est. completion date September 13, 2022
Est. primary completion date September 13, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patients with diabetes and benign prostatic hyperplasia should be on monotherapy with either SGLT inhibitor or DDP4 inhibitors Exclusion Criteria: - unable to consent to the blood sampling or ultrasound Any other diabetes control measure other than SGLT inhibitors or DDP 4 inhibitors

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• International prostate symptom score
Questionnaire of 8 questions to be administered to all patients about prostate symptoms
Diagnostic Test:
• Assessment of prostate volume
Measurements using ultrasound
Other:
• Pittsburgh sleep quality Index
Questionnaire to assess quality of sleep
Diagnostic Test:
• Glycated hemoglobin
Measures control of diabetes

Locations
Country Name City State
Egypt Cairo university hospitals Cairo
Egypt Kasr Alainy University Hospitals Cairo

Sponsors (1)
Lead Sponsor Collaborator
Kasr El Aini Hospital

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary change in prostate volume The delta change in prostate volume as measured by Ultrasound one year
Primary Change in prostate symptoms As indicated by change in the International prostate score system one year
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