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Completed

NCT Number: NCT06148259

SGLT Inhibitors Versus DDP4 Inhibitors and Prostate 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

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Key information

Conditions

Diabetes Mellitus Endocrine System Diseases Genital Diseases Genital Diseases, Male Glucose Metabolism Disorders Male Urogenital Diseases Metabolic Diseases Nutritional and Metabolic Diseases Prostatic Diseases Prostatic Hyperplasia Urogenital Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cairo university hospitals, Cairo, Egypt

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About this study

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

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

International Prostate Symptom Score

Other

Questionnaire of 8 questions to be administered to all patients about prostate symptoms

Assessment of prostate volume

Diagnostic Test

Measurements using ultrasound

Pittsburgh Sleep Quality Index

Other

Questionnaire to assess quality of sleep

Glycated hemoglobin

Diagnostic Test

Measures control of diabetes

Primary outcomes

  1. change in prostate volume

    Time frame: one year

    The delta change in prostate volume as measured by Ultrasound

  2. Change in prostate symptoms

    Time frame: one year

    As indicated by change in the International prostate score system

Sponsors and collaborators

Lead sponsor

Kasr El Aini Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Nov 28, 2023
Registry last updated
Nov 28, 2023

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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