SGLT Inhibitors Versus DDP4 Inhibitors and Prostate in Patient With Diabetes

Study Overview
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Brief Summary
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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
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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

Official Title
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Comparison of Two Novel Anti Diabetes Medications Classes as Regard Prostate Symptoms in Patient With Diabetes

Conditions
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Diabetes Mellitus, Prostatic Hyperplasia

Intervention / Treatment
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* Other: International prostate symptom score
* Diagnostic Test: Assessment of prostate volume
* Other: Pittsburgh sleep quality Index
* Diagnostic Test: Glycated hemoglobin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Sodium glucose cotransporter 2 inhibitors<br>patients with diabetes treated with sodium glucose cotransporter 2- Dapagliflozin | Other: International prostate symptom score<br>* Questionnaire of 8 questions to be administered to all patients about prostate symptoms<br>Diagnostic Test: Assessment of prostate volume<br>* Measurements using ultrasound<br>Other: Pittsburgh sleep quality Index<br>* Questionnaire to assess quality of sleep<br>Diagnostic Test: Glycated hemoglobin<br>* Measures control of diabetes<br>|
| Active Comparator: Dipeptidyl peptidase 4 inhibitors<br>patients with diabetes treated with Dipeptidyl peptidase 4 inhibitor-sitagliptin | Other: International prostate symptom score<br>* Questionnaire of 8 questions to be administered to all patients about prostate symptoms<br>Diagnostic Test: Assessment of prostate volume<br>* Measurements using ultrasound<br>Other: Pittsburgh sleep quality Index<br>* Questionnaire to assess quality of sleep<br>Diagnostic Test: Glycated hemoglobin<br>* Measures control of diabetes<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |