Status:

COMPLETED

Tubular Markers in Response to Saxagliptin Therapy

Lead Sponsor:

Beni-Suef University

Conditions:

Diabetes Mellitus, Type 2

Eligibility:

All Genders

18-80 years

Phase:

PHASE4

Brief Summary

the study aims to investigate whether treatment with saxagliptin would induce beneficial changes in renal NGAL and L-FABP biomarkers and if they would be used as a tool to identify patients' categorie...

Detailed Description

Diabetic kidney disease (DKD) is considered a substantial cause of end-stage kidney disease (ESKD) worldwide. Incorporation of renoprotective options during interventions to prevent the development of...

Eligibility Criteria

Inclusion

  • T2 DM,
  • prevalent albuminuria (30-3000mg/g),
  • controlled hypertension (defined as blood pressure \<140/90 mm Hg) on a selected angiotensin receptor blocker, olmesartan 20mg/day for at least 4 weeks before intervention.

Exclusion

  • type 1 diabetes,
  • poorly controlled hypertension (140-160/90-100 mm Hg),
  • pancreatitis,
  • malignancies
  • albuminuria more than 3000mg/g.
  • cardiovascular diseases (acute myocardial infarction, cerebrovascular disease in the past 6months,
  • End Stage Renal Disease (ESRD) on chronic dialysis, renal transplant, a serum creatinine \>6.0 mg/dL, or estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73 m2.

Key Trial Info

Start Date :

March 1 2019

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

April 1 2020

Estimated Enrollment :

80 Patients enrolled

Trial Details

Trial ID

NCT04521049

Start Date

March 1 2019

End Date

April 1 2020

Last Update

August 20 2020

Active Locations (1)

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Faculty of Pharmacy

Al Qāhirah al Jadīdah, Egypt, 0004