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SGLT Inhibitors Versus DDP4 Inhibitors and Prostate in Patient With Diabetes

NCT ID: NCT06148259

Last Updated: 2023-11-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

57 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-12

Study Completion Date

2022-09-13

Brief Summary

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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

Detailed Description

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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

Conditions

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Diabetes Mellitus Prostatic Hyperplasia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Sodium glucose cotransporter 2 inhibitors

patients with diabetes treated with sodium glucose cotransporter 2- Dapagliflozin

Group Type ACTIVE_COMPARATOR

International prostate symptom score

Intervention Type OTHER

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

Assessment of prostate volume

Intervention Type DIAGNOSTIC_TEST

Measurements using ultrasound

Pittsburgh sleep quality Index

Intervention Type OTHER

Questionnaire to assess quality of sleep

Glycated hemoglobin

Intervention Type DIAGNOSTIC_TEST

Measures control of diabetes

Dipeptidyl peptidase 4 inhibitors

patients with diabetes treated with Dipeptidyl peptidase 4 inhibitor-sitagliptin

Group Type ACTIVE_COMPARATOR

International prostate symptom score

Intervention Type OTHER

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

Assessment of prostate volume

Intervention Type DIAGNOSTIC_TEST

Measurements using ultrasound

Pittsburgh sleep quality Index

Intervention Type OTHER

Questionnaire to assess quality of sleep

Glycated hemoglobin

Intervention Type DIAGNOSTIC_TEST

Measures control of diabetes

Interventions

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International prostate symptom score

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

Intervention Type OTHER

Assessment of prostate volume

Measurements using ultrasound

Intervention Type DIAGNOSTIC_TEST

Pittsburgh sleep quality Index

Questionnaire to assess quality of sleep

Intervention Type OTHER

Glycated hemoglobin

Measures control of diabetes

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kasr El Aini Hospital

OTHER

Sponsor Role lead

Responsible Party

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Tarek Samy Abdelaziz

Associate professor of Internal medicine and nephrology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tarek Abdelaziz

Role: PRINCIPAL_INVESTIGATOR

Cairo University Kasr Alainy Faculty of Medicine

Locations

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Cairo university hospitals

Cairo, , Egypt

Site Status

Kasr Alainy University Hospitals

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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N-136-2023

Identifier Type: -

Identifier Source: org_study_id