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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000045913

Enrollment

Registered

2021-10-30

Start date

2020-06-02

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

type2 diabetes

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: The subjects were type 2 diabetic outpatients who were newly prescribed EPA at 1800mg/day. This prescription was either for the management of hypertriglyceridemia, or due to the diagnosis of CVD risk.

Exclusion criteria

Exclusion 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.

Design outcomes

Primary

Measure	Time frame
The changes in estimated glomerular filtration rate (eGFR) was compared at the initiation of EPA administration (baseline) and after 12 months.	—

Secondary

Measure	Time frame
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.	—

Countries

Japan

Contacts

Public ContactKazuaki Nakai

Ehime Rousai Hospital Department of Internal Medicine

knakai@ehimeh.johas.go.jp0897336191

Outcome results