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

Diabetic Nephropathies Clinical Trial

Official title:

Effect of SGLT2 Inhibitor on Proteinuria in Diabetic Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03573102
• Other study ID #: SGLT2 antiproteinuric effect
• Status: Recruiting
• Phase: Phase 4
• Start date: June 20, 2018
• Est. completion date: July 2020

Study information

• Verified date: February 2020
• Source: Ain Shams University
• Contact: Magdy Sharkawy, MD
• Phone: 00201001422331
• Email: magdi35[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: July 2020
• Est. primary completion date: June 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetic Nephropathies
• Proteinuria

Intervention

Drug:
• SGLT2 inhibitor
SGLT2 inhibitor 10 mg/day
• ACE inhibitor
ACE inhibitor once daily

Locations

Country	Name	City	State
Egypt	Ain Shams University Hospitals	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Nahla H Tohami

Country where clinical trial is conducted

Egypt, 

References & Publications (1)

Lotfy M, Adeghate J, Kalasz H, Singh J, Adeghate E. Chronic Complications of Diabetes Mellitus: A Mini Review. Curr Diabetes Rev. 2017;13(1):3-10. doi: 10.2174/1573399812666151016101622. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	decrease in proteinuria	improvement of proteinuria in patients receiving dapagliflozine	6 months