Effect of Sodium Glucose co Transporter 2 Inhibitor ( SGLT2) on Proteinuria in Diabetic Patients
Primary Purpose
Diabetic Nephropathies
Status
Unknown status
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
SGLT2 inhibitor
ACE inhibitor
Sponsored by
About this trial
This is an interventional treatment trial for Diabetic Nephropathies focused on measuring proteinuria , SGLT2 inhibitors , diabetes
Eligibility Criteria
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.
Sites / Locations
- Ain Shams University HospitalsRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
control
cases
Arm Description
ACE inhibitor , aspirin , statins will be given once daily
SGLT2 inhibitors will be given with classic antiproteinuric drugs
Outcomes
Primary Outcome Measures
decrease in proteinuria
improvement of proteinuria in patients receiving dapagliflozine
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03573102
Brief Title
Effect of Sodium Glucose co Transporter 2 Inhibitor ( SGLT2) on Proteinuria in Diabetic Patients
Official Title
Effect of SGLT2 Inhibitor on Proteinuria in Diabetic Patients
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Unknown status
Study Start Date
June 20, 2018 (Actual)
Primary Completion Date
June 2020 (Anticipated)
Study Completion Date
July 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Nahla H Tohami
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Nephropathies
Keywords
proteinuria , SGLT2 inhibitors , diabetes
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
control
Arm Type
Active Comparator
Arm Description
ACE inhibitor , aspirin , statins will be given once daily
Arm Title
cases
Arm Type
Experimental
Arm Description
SGLT2 inhibitors will be given with classic antiproteinuric drugs
Intervention Type
Drug
Intervention Name(s)
SGLT2 inhibitor
Other Intervention Name(s)
ACE Inhibitor
Intervention Description
SGLT2 inhibitor 10 mg/day
Intervention Type
Drug
Intervention Name(s)
ACE inhibitor
Other Intervention Name(s)
Aspirin , statins
Intervention Description
ACE inhibitor once daily
Primary Outcome Measure Information:
Title
decrease in proteinuria
Description
improvement of proteinuria in patients receiving dapagliflozine
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Magdy Sharkawy, MD
Phone
00201001422331
Email
magdi35@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Nahla H Tohami, MSc
Phone
00201003771280
Email
nahlatohami@med.asu.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Magdy Sharkawy, MD
Organizational Affiliation
Ain Shams University
Official's Role
Study Director
Facility Information:
Facility Name
Ain Shams University Hospitals
City
Cairo
ZIP/Postal Code
002
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nahla H Tohami, MD
Phone
1003771280
Email
dr.nahlahussein@gmail.com
First Name & Middle Initial & Last Name & Degree
Magdy Mohamed Saeed El Sharkawy, MD
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
26472574
Citation
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.
Results Reference
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Effect of Sodium Glucose co Transporter 2 Inhibitor ( SGLT2) on Proteinuria in Diabetic Patients
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