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

Effect of SGLT2 Inhibitor on Proteinuria in Diabetic Patients

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.

Study Overview

• Status: Unknown
• Conditions: Diabetic Nephropathies
• Intervention / Treatment: Drug: ACE inhibitor; Drug: SGLT2 inhibitor

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Magdy Sharkawy, MD; Phone Number: 00201001422331; Email: magdi35@hotmail.com
• Study Contact Backup: Name: Nahla H Tohami, MSc; Phone Number: 00201003771280; Email: nahlatohami@med.asu.edu.eg

Study Locations

• Egypt
  • Cairo, Egypt, 002
    • Recruiting
    • Ain Shams University Hospitals
    • Contact: Nahla H Tohami, MD; Phone Number: 1003771280; Email: dr.nahlahussein@gmail.com
    • Principal Investigator: magdy Mohamed Saeed El Sharkawy, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Nahla H Tohami
• Investigators: Study Director: Magdy Sharkawy, MD, Ain Shams University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 20, 2018
• Primary Completion (Anticipated): June 1, 2020
• Study Completion (Anticipated): July 1, 2020

Study Registration Dates

• First Submitted: March 12, 2018
• First Submitted That Met QC Criteria: June 27, 2018
• First Posted (Actual): June 29, 2018

Study Record Updates

• Last Update Posted (Actual): April 21, 2020
• Last Update Submitted That Met QC Criteria: April 18, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: proteinuria , SGLT2 inhibitors , diabetes
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Urological Manifestations; Endocrine System Diseases; Diabetes Complications; Diabetes Mellitus; Urination Disorders; Diabetic Nephropathies; Proteinuria; Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protease Inhibitors; Sodium-Glucose Transporter 2 Inhibitors; Angiotensin-Converting Enzyme Inhibitors
• Other Study ID Numbers: SGLT2 antiproteinuric effect

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes