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Highly purified eicosapentaenoic acid ethyl ester supplementation in the management of type 2 diabetic patients: effects on renal function, on dyslipidemia, and on hyperglycemia.

Basic Information

Recruitment status	Complete: follow-up complete
Health condition(s) or Problem(s) studied	type2 diabetes
Date of first enrollment	2020/06/02
Target sample size	80
Countries of recruitment	Japan
Study type	Observational
Intervention(s)

Outcome(s)

Primary Outcome	The changes in estimated glomerular filtration rate (eGFR) was compared at the initiation of EPA administration (baseline) and after 12 months.
Secondary Outcome	The changes in patients'demographics and laboratory data including hemoglobin A1c (HbA1c) and lipid parameters were compared at the initiation of EPA administration (baseline) and after 12 months.

Key inclusion & exclusion criteria

Age minimum	20years-old
Age maximum	90years-old
Gender	Male and Female
Include criteria
Exclude criteria	(a)receiving hemodialysis;(b) being suspected of having kidney disease other than DKD;(c) being suspected of having muscle atrophy because of gait disturbance;(d) being treated with sodium-glucose cotransporter 2 inhibitors and glucagon-like peptide 1 receptor agonists (both treatments have been reported to have renoprotective effects);(e) receiving additional prescription of new class of glucose-lowering drugs, or new agents which can influence eGFR, within 12 months from the initiation of EPA administration; (f) new onset of systemic disease; (g) the patient's eGFR was measured less than six times during the follow-up period; (h) the patient's UACR was not measured either within the six months before the initiation of EPA administration or at 12 months; (i) the patient's BMI and blood pressure were not measured within the three months before the initiation of or at 12 months.(j) the patient's eGFR was more than 90 ml/min/1.73m2.