SGLT Inhibitors Versus DDP4 Inhibitors and Prostate in Patient With Diabetes

NCT06148259 | Completed

• 1 other identifier: N-136-2023
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 2

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

Conditions

Diabetes Mellitus; Prostatic Hyperplasia

Outcome Measures

Primary Outcomes (2)

• change in prostate volume

  The delta change in prostate volume as measured by Ultrasound

  one year

• Change in prostate symptoms

  As indicated by change in the International prostate score system

  one year

Study Arms (2)

Sodium glucose cotransporter 2 inhibitors

ACTIVE COMPARATOR

patients with diabetes treated with sodium glucose cotransporter 2- Dapagliflozin

Other: International prostate symptom score; Diagnostic Test: Assessment of prostate volume; Other: Pittsburgh sleep quality Index; Diagnostic Test: Glycated hemoglobin

Dipeptidyl peptidase 4 inhibitors

ACTIVE COMPARATOR

patients with diabetes treated with Dipeptidyl peptidase 4 inhibitor-sitagliptin

Other: International prostate symptom score; Diagnostic Test: Assessment of prostate volume; Other: Pittsburgh sleep quality Index; Diagnostic Test: Glycated hemoglobin

Interventions

International prostate symptom score OTHER

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

Dipeptidyl peptidase 4 inhibitors; Sodium glucose cotransporter 2 inhibitors

Assessment of prostate volume DIAGNOSTIC_TEST

Measurements using ultrasound

Dipeptidyl peptidase 4 inhibitors; Sodium glucose cotransporter 2 inhibitors

Pittsburgh sleep quality Index OTHER

Questionnaire to assess quality of sleep

Dipeptidyl peptidase 4 inhibitors; Sodium glucose cotransporter 2 inhibitors

Glycated hemoglobin DIAGNOSTIC_TEST

Measures control of diabetes

Dipeptidyl peptidase 4 inhibitors; Sodium glucose cotransporter 2 inhibitors

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Male patients with benign prostatic hyperplasia
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with diabetes and benign prostatic hyperplasia should be on monotherapy with either SGLT inhibitor or DDP4 inhibitors

You may not qualify if:

• unable to consent to the blood sampling or ultrasound Any other diabetes control measure other than SGLT inhibitors or DDP 4 inhibitors

Sponsors & Collaborators

• Kasr El Aini Hospital: lead

Study Sites (2)

Cairo university hospitals

Cairo, Egypt

Location

Kasr Alainy University Hospitals

Cairo, Egypt

Location

MeSH Terms

Conditions

Diabetes Mellitus; Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Tarek Abdelaziz

  Cairo University Kasr Alainy Faculty of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor of Internal medicine and nephrology

Study Record Dates

• First Submitted: November 14, 2023
• First Posted: November 28, 2023
• Study Start: March 12, 2021
• Primary Completion: September 13, 2022
• Study Completion: September 13, 2022
• Last Updated: November 28, 2023

Record last verified: 2023-11

Locations

EG (2)