SGLT Inhibitors Versus DDP4 Inhibitors and Prostate in Patient With Diabetes

November 19, 2023 updated by: Tarek Samy Abdelaziz, Kasr El Aini Hospital

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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

Study Type

Interventional

Enrollment (Actual)

57

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt
        • Cairo university hospitals
      • Cairo, Egypt
        • Kasr Alainy University Hospitals

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Sodium glucose cotransporter 2 inhibitors
patients with diabetes treated with sodium glucose cotransporter 2- Dapagliflozin
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
Active Comparator: Dipeptidyl peptidase 4 inhibitors
patients with diabetes treated with Dipeptidyl peptidase 4 inhibitor-sitagliptin
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in prostate volume
Time Frame: one year
The delta change in prostate volume as measured by Ultrasound
one year
Change in prostate symptoms
Time Frame: one year
As indicated by change in the International prostate score system
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kasr El Aini Hospital

Investigators

  • Principal Investigator: Tarek Abdelaziz, Cairo University Kasr Alainy Faculty of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 12, 2021

Primary Completion (Actual)

September 13, 2022

Study Completion (Actual)

September 13, 2022

Study Registration Dates

First Submitted

November 14, 2023

First Submitted That Met QC Criteria

November 19, 2023

First Posted (Actual)

November 28, 2023

Study Record Updates

Last Update Posted (Actual)

November 28, 2023

Last Update Submitted That Met QC Criteria

November 19, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • N-136-2023

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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