SGLT Inhibitors Versus DDP4 Inhibitors and Prostate in Patient With Diabetes

Not Applicable

Completed

• Conditions: Diabetes Mellitus; Prostatic Hyperplasia
• Interventions: Other: International prostate symptom score; Diagnostic Test: Assessment of prostate volume; Other: Pittsburgh sleep quality Index; Diagnostic Test: Glycated hemoglobin

• Registration Number: NCT06148259
• Lead Sponsor: Kasr El Aini Hospital

Brief 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

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 Timeline

• Study Start: 2021-03-12
• Primary Completion: 2022-09-13
• Study Completion: 2022-09-13
• Status Verified: 2023-11
• Study First Submitted: 2023-11-14
• Study First Submitted QC: 2023-11-19
• Last Update Submitted: 2023-11-19
• Study First Posted: 2023-11-28
• Last Update Posted: 2023-11-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 57

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sodium glucose cotransporter 2 inhibitors	Assessment of prostate volume	patients with diabetes treated with sodium glucose cotransporter 2- Dapagliflozin
Sodium glucose cotransporter 2 inhibitors	Pittsburgh sleep quality Index	patients with diabetes treated with sodium glucose cotransporter 2- Dapagliflozin
Sodium glucose cotransporter 2 inhibitors	Glycated hemoglobin	patients with diabetes treated with sodium glucose cotransporter 2- Dapagliflozin
Dipeptidyl peptidase 4 inhibitors	International prostate symptom score	patients with diabetes treated with Dipeptidyl peptidase 4 inhibitor-sitagliptin
Sodium glucose cotransporter 2 inhibitors	International prostate symptom score	patients with diabetes treated with sodium glucose cotransporter 2- Dapagliflozin
Dipeptidyl peptidase 4 inhibitors	Glycated hemoglobin	patients with diabetes treated with Dipeptidyl peptidase 4 inhibitor-sitagliptin
Dipeptidyl peptidase 4 inhibitors	Pittsburgh sleep quality Index	patients with diabetes treated with Dipeptidyl peptidase 4 inhibitor-sitagliptin
Dipeptidyl peptidase 4 inhibitors	Assessment of prostate volume	patients with diabetes treated with Dipeptidyl peptidase 4 inhibitor-sitagliptin

Primary Outcome Measures

Name	Time	Method
change in prostate volume	one year	The delta change in prostate volume as measured by Ultrasound
Change in prostate symptoms	one year	As indicated by change in the International prostate score system

Trial Locations

Locations (2)

Cairo university hospitals; 🇪🇬 Cairo, Egypt

Kasr Alainy University Hospitals; 🇪🇬 Cairo, Egypt