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

NCT ID: NCT03573102

Last Updated: 2020-04-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-20

Study Completion Date

2020-07-31

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.

Conditions

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Diabetic Nephropathies

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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control

ACE inhibitor , aspirin , statins will be given once daily

Group Type ACTIVE_COMPARATOR

ACE inhibitor

Intervention Type DRUG

ACE inhibitor once daily

cases

SGLT2 inhibitors will be given with classic antiproteinuric drugs

Group Type EXPERIMENTAL

SGLT2 inhibitor

Intervention Type DRUG

SGLT2 inhibitor 10 mg/day

ACE inhibitor

Intervention Type DRUG

ACE inhibitor once daily

Interventions

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SGLT2 inhibitor

SGLT2 inhibitor 10 mg/day

Intervention Type DRUG

ACE inhibitor

ACE inhibitor once daily

Intervention Type DRUG

Other Intervention Names

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ACE Inhibitor Aspirin , statins

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nahla H Tohami

OTHER

Sponsor Role lead

Responsible Party

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Nahla H Tohami

Assistent lecturer of nephrology

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Magdy Sharkawy, MD

Role: STUDY_DIRECTOR

Ain Shams University

Locations

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Ain Shams University Hospitals

Cairo, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Magdy Sharkawy, MD

Role: CONTACT

00201001422331

Nahla H Tohami, MSc

Role: CONTACT

00201003771280

Facility Contacts

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Nahla H Tohami, MD

Role: primary

1003771280

References

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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.

Reference Type BACKGROUND
PMID: 26472574 (View on PubMed)

Other Identifiers

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SGLT2 antiproteinuric effect

Identifier Type: -

Identifier Source: org_study_id

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