Diabetes MellitusNCT06148259
SGLT Inhibitors Versus DDP4 Inhibitors and Prostate in Patient With Diabetes
A study testing International prostate symptom score, Assessment of prostate volume and Pittsburgh sleep quality Index in people with Diabetes Mellitus and Prostatic Hyperplasia, run by Kasr El Aini Hospital at 2 sites in Egypt.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Prostatic Hyperplasia
- What is being tested?
- International prostate symptom score, Assessment of prostate volume and Pittsburgh sleep quality Index
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 2 sitesEgypt
- Study dates
- 12 Mar 2021to 13 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with diabetes and benign prostatic hyperplasia should be on monotherapy with either SGLT inhibitor or DDP4 inhibitors
Who cannot join
- unable to consent to the blood sampling or ultrasound Any other diabetes control measure other than SGLT inhibitors or DDP 4 inhibitors
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
Cairo university hospitals
Cairo
Kasr Alainy University Hospitals
Cairo
About this study
Official title: 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
Read the 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
- Conditions
- Diabetes Mellitus, Prostatic Hyperplasia
- Being tested
- International prostate symptom score, Assessment of prostate volume, Pittsburgh sleep quality Index, Glycated hemoglobin
- Medical subject headings
- Diabetes Mellitus, Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
International prostate symptom scoreOther
Questionnaire of 8 questions to be administered to all patients about prostate symptoms
Assessment of prostate volumeDiagnostic test
Measurements using ultrasound
Pittsburgh sleep quality IndexOther
Questionnaire to assess quality of sleep
Glycated hemoglobinDiagnostic test
Measures control of diabetes
| Study group | Role | What they receive |
|---|---|---|
| Sodium glucose cotransporter 2 inhibitors | Active comparator | patients with diabetes treated with sodium glucose cotransporter 2- Dapagliflozin Receives: 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 Receives: Other: International prostate symptom score; Diagnostic Test: Assessment of prostate volume; Other: Pittsburgh sleep quality Index; Diagnostic Test: Glycated hemoglobin |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in prostate volume
The delta change in prostate volume as measured by Ultrasound
Measured: one year
Change in prostate symptoms
As indicated by change in the International prostate score system
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2023
- Study start12 Mar 2021
- Primary completion13 Sep 2022
- Study completion13 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kasr El Aini Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tarek Samy Abdelaziz, Kasr El Aini Hospital
- Investigators
- Tarek Abdelaziz, Principal investigator, Cairo University Kasr Alainy Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06148259
- Sponsor's protocol ID
- N-136-2023
- Status last verified
- Nov 2023
- First submitted
- 14 Nov 2023
- Last updated
- 28 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Novel Anti Diabetes Medications Classes as Regard Prostate Symptoms in Patient With Diabetes
- ClinicalTrials.gov ID
- NCT06148259
- Acronym / sponsor ID
- N-136-2023
- Conditions
- Diabetes Mellitus, Prostatic Hyperplasia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Kasr El Aini HospitalUniversity, hospital or other
- Study start
- 12 Mar 2021 (actual)
- Primary completion
- 13 Sep 2022 (actual)
- Study completion
- 13 Sep 2022 (actual)
- First posted
- 28 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sodium glucose cotransporter 2 inhibitors | Active comparator | Other: International prostate symptom score, Diagnostic Test: Assessment of prostate volume, Other: Pittsburgh sleep quality Index, Diagnostic Test: Glycated hemoglobinpatients with diabetes treated with sodium glucose cotransporter 2- Dapagliflozin |
| Dipeptidyl peptidase 4 inhibitors | Active comparator | Other: International prostate symptom score, Diagnostic Test: Assessment of prostate volume, Other: Pittsburgh sleep quality Index, Diagnostic Test: Glycated hemoglobinpatients with diabetes treated with Dipeptidyl peptidase 4 inhibitor-sitagliptin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with diabetes and benign prostatic hyperplasia should be on monotherapy with either SGLT inhibitor or DDP4 inhibitors
Key exclusion criteria (1 listed)
- unable to consent to the blood sampling or ultrasound Any other diabetes control measure other than SGLT inhibitors or DDP 4 inhibitors
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| International prostate symptom scoreQuestionnaire of 8 questions to be administered to all patients about prostate symptoms | Other | Dipeptidyl peptidase 4 inhibitors, Sodium glucose cotransporter 2 inhibitors |
| Assessment of prostate volumeMeasurements using ultrasound | Diagnostic test | Dipeptidyl peptidase 4 inhibitors, Sodium glucose cotransporter 2 inhibitors |
| Pittsburgh sleep quality IndexQuestionnaire to assess quality of sleep | Other | Dipeptidyl peptidase 4 inhibitors, Sodium glucose cotransporter 2 inhibitors |
| Glycated hemoglobinMeasures control of diabetes | Diagnostic test | Dipeptidyl peptidase 4 inhibitors, Sodium glucose cotransporter 2 inhibitors |
Primary outcome
change in prostate volume
Time frame: one year
The delta change in prostate volume as measured by Ultrasound
Change in prostate symptoms
Time frame: one year
As indicated by change in the International prostate score system
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tarek Abdelaziz principal investigator
Cairo University Kasr Alainy Faculty of Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing International prostate symptom score, Assessment of prostate volume and Pittsburgh sleep quality Index in people with Diabetes Mellitus and Prostatic Hyperplasia, run by Kasr El Aini Hospital at 2 sites in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in prostate volume (time frame: one year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2023.