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

Nahla H Tohami

Status and phase: Unknown; Phase 4

Conditions: Diabetic Nephropathies

Treatments: Drug: SGLT2 inhibitor; Drug: ACE inhibitor

Study type: Interventional

Funder types: Other

Identifiers

NCT03573102

SGLT2 antiproteinuric effect

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

control

Active Comparator group

Description:

ACE inhibitor , aspirin , statins will be given once daily

Treatment:

Drug: ACE inhibitor

cases

Experimental group

Description:

SGLT2 inhibitors will be given with classic antiproteinuric drugs

Treatment:

Drug: ACE inhibitor

Drug: SGLT2 inhibitor