- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06148259
SGLT Inhibitors Versus DDP4 Inhibitors and Prostate in Patient With Diabetes
November 19, 2023 updated by: Tarek Samy Abdelaziz, Kasr El Aini Hospital
Comparison of Two Novel Anti Diabetes Medications Classes as Regard Prostate Symptoms 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
Study Overview
Status
Completed
Conditions
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 Type
Interventional
Enrollment (Actual)
57
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Cairo, Egypt
- Cairo University Hospitals
-
Cairo, Egypt
- Kasr Alainy University Hospitals
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Sodium glucose cotransporter 2 inhibitors
patients with diabetes treated with sodium glucose cotransporter 2- Dapagliflozin
|
Questionnaire of 8 questions to be administered to all patients about prostate symptoms
Measurements using ultrasound
Questionnaire to assess quality of sleep
Measures control of diabetes
|
Active Comparator: Dipeptidyl peptidase 4 inhibitors
patients with diabetes treated with Dipeptidyl peptidase 4 inhibitor-sitagliptin
|
Questionnaire of 8 questions to be administered to all patients about prostate symptoms
Measurements using ultrasound
Questionnaire to assess quality of sleep
Measures control of diabetes
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
change in prostate volume
Time Frame: one year
|
The delta change in prostate volume as measured by Ultrasound
|
one year
|
Change in prostate symptoms
Time Frame: one year
|
As indicated by change in the International prostate score system
|
one year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Tarek Abdelaziz, Cairo University Kasr Alainy Faculty of Medicine
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 12, 2021
Primary Completion (Actual)
September 13, 2022
Study Completion (Actual)
September 13, 2022
Study Registration Dates
First Submitted
November 14, 2023
First Submitted That Met QC Criteria
November 19, 2023
First Posted (Actual)
November 28, 2023
Study Record Updates
Last Update Posted (Actual)
November 28, 2023
Last Update Submitted That Met QC Criteria
November 19, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Glucose Metabolism Disorders
- Metabolic Diseases
- Endocrine System Diseases
- Prostatic Diseases
- Urogenital Diseases
- Male Urogenital Diseases
- Genital Diseases, Male
- Genital Diseases
- Diabetes Mellitus
- Prostatic Hyperplasia
- Hyperplasia
- Physiological Effects of Drugs
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Chrysarobin
Other Study ID Numbers
- N-136-2023
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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