Effect of Renin-angiotensin-system Blockade on Urinary Free Light Chains in Patients With Type 2 Diabetes Mellitus

• Status: Completed
• Trial end date: 2019-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to study the effect of blocking the renin angiotensin system on urinary free light chain excretion as compared to urine microalbumin creatinine ratio in subjects with type 2 diabetes. The long term goal is to assess urinary free-light chains as a biomarker of earlier detection of kidney function impairment in subjects with diabetes mellitus.

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

Details

• Lead Sponsor: Tulane University Health Sciences Center; Tulane University School of Medicine
• Treatments: Amlodipine; Hydralazine; Hydrochlorothiazide; Terazosin

Criteria

Inclusion Criteria:

• Type 2 Diabetes

• Hypertension

• Estimated glomerular filtration rate (eGFR) > 30 ml/min

• Use of Ace Inh and ARB for control of blood pressure who are willing to be placed on alternate drug(s) in the washout period for blood pressure control

Exclusion Criteria:

• Pregnancy

• Patients with chronic kidney disease stage with eGFR < 30 ml/min (CKD stage IV and V)

• Nephrotic range proteinuria (urinary protein > 3.5 gm/day)

• History or renal transplantation

• History of multiple myeloma

• Known history of hypersensitivity reaction or intolerability to Ace Inh or ARB.