EDEN study

Recruitment & Eligibility

Inclusion Criteria

Who aged 18 years or older at the time of consent
Who meet either and or both of the following renal criteria within 60 days before enrollment
A) eGFR less than 60mL/min/1.73m2 B) Urinary protein/urinary creatine ratio of 0.15 g/gcre or higher
Who have an elevated fasting TG/HDL ratio within 60 days before enrollment(2.967 or higher for men, 2.237 or higher for women)
Whose treatment for diabetes, hypertension or dyslipidemia (including dietary and exercise therapy) has not changed within 90 days before obtaining consent

Exclusion Criteria

Who have taken fibrates, selective PPARalpha modulators, or n3-polyunsaturated fatty acids within 90 days before obtaining consent
With TG levels of 500 mg/dL or higher
Who are pregnant, breastfeeding, or planning to be pregnant during study period
With poorly controlled(glycated A1c(NGSP) > 10%)
With uncontrolled hypertension despite optimal antihypertensive agents(either systolic blood pressure >=180 mmHg or diastolic blood pressure >=110mmHg)
With severe liver dysfunction(AST(GOT) or ALT(GPT) >=100 IU/L)
With severe renal dysfunction(eGFR < 30 mL/min/1.73m2)
With a concurrent malignancy
Who participated in another clinical trial (interventional study) within 90 days prior to the study drug administration
Whom the principal investigator or sub-investigator deems inappropriate for study participation

Study & Design

Primary Outcome Measures

Name	Time	Method
-		Changes in serum TG/HDL ratio 4 weeks after administration of D-alanine

Secondary Outcome Measures

Name	Time	Method
TG		Changes in TG
HDL		Changes in HDL
LDL		Changes in LDL
AST		Changes in AST
ALT		Changes in ALT
systolic blood pressure		Changes in systolic blood pressure
diastolic pressure		Changes in diastolic pressure
urinary protein (Uprot/Ucre)		Changes in urinary protein (Uprot/Ucre)
eGFR		Changes in eGFR
body weight		Changes in body weight

Recruitment & Eligibility