Study for the effects of switching from angiotensin II receptor blockers to sacubitril valsartan or adding trichlormethiazide on markers of renal injury in subjects with type 2 diabetes complicated with diabetic nephropathy

JRCT ID: jRCT1011240028

Registered date:20/08/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Type 2 diabetes
• Date of first enrollment: 20/08/2024
• Target sample size: 30
• Study type: Interventional
• Intervention(s): 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 trichlormethiazide (2 mg/day). 12 weeks (+5 weeks) at the outpatient visit, the same evaluation as for the initial visit (Evaluation 2). This will be followed by a switch from sacubitril valsartan back to the previous ARB with the addition of trichlormethiazide or vice versa, another 12 weeks (+5 weeks) of outpatient treatment, and another evaluation (evaluation 3), which will conclude the study.

Outcome(s)

• Primary Outcome: Changes in urinary L-FABP and urinary albumin before and after switching from ARB to sacubitril valsartan or adding trichlormethiazide

Secondary Outcome

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.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 90age old
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Nomoto Hiroshi