Effect of Sodium Glucose co Transporter 2 Inhibitor ( SGLT2) on Proteinuria in Diabetic Patients

Study Overview
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Brief Summary
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Diabetes Mellitus is the leading cause of end stage renal disease. As proven by many studies , controlling proteinuria can delay the progression to end stage renal disease.This work will study the effect of sodium glucose co transporter 2 inhibitor , a new antihyperglycemic drug , on proteinuria and to compare its effect with the effect of classic antiproteinuric drugs as angiotensin converting enzyme inhibitor , aspirin and statins.

Detailed Description
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Diabetic nephropathy involves progressive stages including glomerular hyperfilteration , microalbuminuria , overt proteinuria and a decline in glomerular filteration rate leading to end stage renal disease. Despite all the available interventions available for diabetic patients including tight glycemic control , and blood pressure control , using angiotensin converting enzyme inhibitors, angiotensin II receptor antagonist renal disease remains prevalent and progress in these patients. The newer therapy of diabetes is the use of sodium glucose cotransporter 2 inhibitor as it has the potential of renoprotection in patients with diabetic nephropathy just as ACEI and ARBS to reduce glomerular hyperfilteration .This action may reduce albuminuria.

Official Title
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Effect of SGLT2 Inhibitor on Proteinuria in Diabetic Patients

Conditions
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Diabetic Nephropathies

Intervention / Treatment
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* Drug: SGLT2 inhibitor
* Drug: ACE inhibitor


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: adult patients with type 2 diabetes. controlled diabetes. patients with proteinuria Exclusion Criteria: patients with proteinuria due to other disease. patients with HbA1c >8%. patients with uncontrolled hypertension. patients with chronic liver disease. patients with type 1 diabetes . patients already on the same drug ( dapagliflozine). patients with raised serum creatinine.

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: control<br>ACE inhibitor , aspirin , statins will be given once daily | Drug: ACE inhibitor<br>* ACE inhibitor once daily<br>* Other names: Aspirin , statins;|
| Experimental: cases<br>SGLT2 inhibitors will be given with classic antiproteinuric drugs | Drug: SGLT2 inhibitor<br>* SGLT2 inhibitor 10 mg/day<br>* Other names: ACE Inhibitor;Drug: ACE inhibitor<br>* ACE inhibitor once daily<br>* Other names: Aspirin , statins;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| decrease in proteinuria | improvement of proteinuria in patients receiving dapagliflozine | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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proteinuria , SGLT2 inhibitors , diabetes