Type 2 diabetes
Conditions
Interventions
Consent will be obtained from eligible patients and an initial examination will be performed (Evaluation 1), followed by a switch from ARB to sacubitril valsartan (200 mg/day) or addition of trichlorm
Sponsors
Nomoto Hiroshi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Age between 20 and 90 years 2) Diagnosis with type 2 diabetes complicated by hypertension with diabetic nephropathy stage 2 (A2) or higher 3) Subjects receiving ARBs at or above the usual dose for 12 weeks or more prior to consent acquisition 4) Subjects not achieving antihypertensive goals 5) Written informed consent
Exclusion criteria
Exclusion criteria: 1) History of anaphylaxis of sacubitril valsartan or trichlormethiazide 2) Subjects receiving sacubitril valsartan and/or trichlormethiazide 3) serum K < 3.5 mEq/L 4) eGFR < 30 mL/min/1.73m2 5) Subjects with severe hepatic dysfunction (Child-Pugh classification C) 6) Subjects receiving angiotensin-converting enzyme inhibitors 7) Pregnant women or patients who may be pregnant 8) Inability to consume an appropriate diet 9) Incompatibility with the trial for other reasons, as determined by a physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in urinary L-FABP and urinary albumin before and after switching from ARB to sacubitril valsartan or adding trichlormethiazide | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Changes in systolic and diastolic blood pressure, pulse rate, and body weight 2) Changes in HbA1c and its relationship to various assessment data 3) Changes in various blood and urine tests and their relationship to various assessment data 4) Changes in urinary biomarkers and their relationship to various assessment data 5) Changes in insulin secretory capacity and resistance indices and their relationship to various assessment data 6) Changes in oxidative stress and antioxidant indices and their relationship to various evaluation data 7) Presence and severity of disease, etc. | — |
Contacts
Public ContactHiroshi Nomoto
Asahikawa Medical University
Outcome results
None listed