Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 5:09 AM
Ignite Modification Date:
2025-12-25 @ 5:09 AM
NCT ID:
NCT00758927
Eligibility Criteria:
Inclusion Criteria:
* Agreed for informed consent
* Age between 40-70 years old
* Type 2 diabetes mellitus
* Combined hyperlipidemia
* Serum triglyceride level between 200-500(mg/dl)
* No sudden change of glucose lowering therapies during trial, anticipated
Exclusion Criteria:
* Hypersensitivity to OMACOR(Omega-3 fatty acid)
* Alcoholics
* Pregnancy
* Proliferative diabetic retinopathy
* Patients already taking fibrates
* Enrolled in other clinical trials during the recent 3 months
* Severe ischemic heart disease, liver disease, neurological disease
* AST/ALT level 2 folds above the normal reference level
* Psychiatric disorder not adequately controlled
* Serum creatinine over 2.0 (mg/dl)
* Previous pancreatic surgery
* Patients who can not maintain regular diet
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
70 Years
Study:
NCT00758927
Study Brief:
Protocol Section:
NCT00758927