Phase 4
N=28
Effect of Renin-angiotensin-system Blockade on Urinary Free Light Chains in Patients With Type 2 Diabetes Mellitus
Type 2 Diabetes · Hypertension
Bottom Line
View on ClinicalTrials.gov: NCT02046395 ↗Enrolled (actual)
28
Serious AEs
0.0%
Results posted
Aug 2023
Primary outcome: Primary: Change in Urine Microalbumin Creatinine Ratio — 15 mg/g
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- amlodipine, hydralazine, terazosin or hydrochlorothiazide (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Tulane University School of Medicine
- Primary completion
- Dec 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Urine Microalbumin Creatinine Ratio |
15 | — |
| SECONDARY Change in the Level of Urinary Free Light Chains |
1.14 | — |
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.
Eligibility 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 3.5 gm/day)
- History or renal transplantation
- History of multiple myeloma
- Known history of hypersensitivity reaction or intolerability to Ace Inh or ARB.
Data sourced from ClinicalTrials.gov (NCT02046395). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.