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Survey research on the effects of statin alone or a combination of statin and EPA on endothelial function in patients with type 2 diabetes complicated with dyslipidemia

Survey research on the effects of statin alone or a combination of statin and EPA on endothelial function in patients with type 2 diabetes complicated with dyslipidemia - Survey research on the effects of statin alone or a combination of statin and EPA on endothelial function in patients with type 2 diabetes complicated with dyslipidemia

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000005783
Enrollment
30
Registered
2011-06-17
Start date
2007-06-01
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

type 2 diabetes

Interventions

Continuing statin alone: a statin preparation (type unspecified, at a normal dosage) A combination with EPA: a statin preparation + Epadel of 1,800 mg a day.

Sponsors

The Department of Diabetes, Endocrinology and Metabolism, Tokyo Medical University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: The patients with type 2 diabetes mellitus, complicated with dyslipidemia and who have given written informed consent to participate in the current study.

Exclusion criteria

Exclusion criteria: Those patients who meet any of the following conditions were excluded from the current study: 1) Currently suffer from cerebral hemorrhage or have had it in the past 2) Have embolism or hemorrhagic infarction 3) Are currently suffering from a hemorrhage (conditions such as hemophilia, capillary fragility, hemorrhage from the digestive system, urinary tract hemorrhage, hemoptysis, and vitreous hemorrhage) 4) Have severe congestive heart failure 5) Have a history of hypersensitivity to statin or components of EPA 6) Have a peptic ulcer 7) Have a severe hematological anomaly 8) Have a severe complication (such as a malignant tumor, liver cirrhosis, renal failure and heart failure) 9) Those who failed to give informed consent 10) Other patients whom the chief investigator or attending physician finds unsuitable

Design outcomes

Primary

MeasureTime frame
Assessing endothelial function of patients with type 2 diabetes, using strain-gauge plethysmography.

Secondary

MeasureTime frame
Pulse wave velocity(PWV) and intima-media thickness(IMT) of carotid artery echogram before and after EPA administration.

Countries

Japan

Contacts

Public ContactTakashi Miwa

Tokyo Medical University The Department of Diabetes, Endocrinology and Metabolism

miwa-t@tokyo-med.ac.jp

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026