Tubular Markers in Response to Saxagliptin Therapy

• Status: Completed
• Trial end date: 2020-04-01
• Target enrollment: 0
• Participant gender: All

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' categories with a particular renal response to DPP-4inhibition. Secondly, to find an association between NGAL and L-FABP, and the relevant renal parameters for both baseline values and rate of changes across defined time points.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Beni-Suef University
• Treatments: Saxagliptin

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.