SGLT Inhibitors Versus DDP4 Inhibitors and Prostate in Patient With Diabetes

• Sponsor: Kasr El Aini Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT06148259
• Collaborator: (none)
• Enrollment: 57
• Locations: 2
• Arms: 2
• Actual Duration (Months): 18.1
• Patients Per Site: 28.5
• Patients Per Site Per Month: 1.6

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus; Prostatic Hyperplasia	Other: International prostate symptom score; Diagnostic Test: Assessment of prostate volume; Other: Pittsburgh sleep quality Index; Diagnostic Test: Glycated hemoglobin	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 57 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Comparison of Two Novel Anti Diabetes Medications Classes as Regard Prostate Symptoms in Patient With Diabetes
• Actual Study Start Date: Mar 12, 2021
• Actual Primary Completion Date: Sep 13, 2022
• Actual Study Completion Date: Sep 13, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. change in prostate volume [one year]

   The delta change in prostate volume as measured by Ultrasound

2. Change in prostate symptoms [one year]

   As indicated by change in the International prostate score system

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cairo university hospitals	Cairo		Egypt
2	Kasr Alainy University Hospitals	Cairo		Egypt

Sponsors and Collaborators

• Kasr El Aini Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Tarek Samy Abdelaziz, Associate professor of Internal medicine and nephrology, Kasr El Aini Hospital
• ClinicalTrials.gov Identifier: NCT06148259
• Other Study ID Numbers: N-136-2023
• First Posted: Nov 28, 2023
• Last Update Posted: Nov 28, 2023
• Last Verified: Nov 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Prostatic Hyperplasia; Diabetes Mellitus; Hyperplasia; Chrysarobin

Study Results

No Results Posted as of Nov 28, 2023