Ignite Creation Date:
2024-05-06 @ 7:46 PM
Last Modification Date:
2024-10-26 @ 3:13 PM
Study NCT ID:
NCT06129526
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-11-15
First Post:
2023-11-02
Brief Title:
Study of the Efficacy and Safety of EPA in Patients With Type-2 Diabetes
Sponsor:
University of Ioannina
Organization:
University of Ioannina
Study Overview
Official Title:
Study of the Effect of Eicosapentaenoic Acid EPA on Markers of Atherothrombosis in Patients With Type-2 Diabetes
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SEASIDE
Brief Summary:
Investigation of the efficacy and safety of an Eicosapentaenoic acid EPA supplement versus a placebo supplement on plasma triglyceride levels as well as inflammatory thrombotic endothelial and platelet activation markers in patients with type-2 diabetes mellitus DM-2
Detailed Description:
The conflicting results of previous clinical trials regarding the clinical efficacy of omega-3 fatty acids such as the STRENGTH and REDUCE-IT studies as well as the published comments for the placebo used in the REDUCE-IT study mineral oil highlight the need for additional studies pharmacodynamic clinical and basic research studies The SEASIDE Study of the Effect of Eicosapentaenoic acid EPA on Markers of Atherothrombosis in Patients with Type-2 Diabetes is a phase 4 clinical study aiming to investigate the efficacy of the dietary supplement EPAVasc consisted of 1875mg EPA 125mg Docosahexaenoic acid DHA 375μg Vitamin D 12mg tocopherol in reducing the plasma levels of triglycerides markers of inflammation coagulation and platelet as well as endothelial functionality in high or very high cardiovascular risk DM-2 patients as compared with the administration of a placebo dietary supplement Corn Oil The safety of administering the above EPA supplementation to these patients will be also investigated This study is expected to significantly advance the existing knowledge regarding the efficacy of EPA in reducing important cardiovascular risk biomarkers in high or very high cardiovascular risk DM-2 patients
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None