Ignite Creation Date:
2024-05-05 @ 4:58 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00350194
Status:
UNKNOWN
Last Update Posted:
2012-03-02
First Post:
2006-07-06
Brief Title:
The Effects of Omega-3 Fatty Acids on Metabolic Syndrome
Sponsor:
University of Washington
Organization:
University of Washington
Study Overview
Official Title:
Pilot Study The Effects of Omega-3 Fatty Acids on Metabolic Syndrome and Vascular Structure in Metabolic Syndrome as Assessed by Carotid IMT
Status:
UNKNOWN
Status Verified Date:
2012-02
Last Known Status:
ACTIVE_NOT_RECRUITING
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:
None
Brief Summary:
The purpose of this study is to determine the effects of omega-3 fatty acids in the form of fish oil supplementation approximately 2 grams per day on the carotid intima-media CIMTprogression primary objective and 2Secondary objective lipid markers such as LDL apo-B and LDL buoyancy on inflammatory burden as measured by CRP on oxidative stress as measured by urinary isoprostanes urine microalbumincreatinine and serum adiponectin a fat derived hormone in subjects with metabolic syndrome
Detailed Description:
This translational pilot study will have a double-blind placebo-controlled parallel design We will enroll one hundred subjects who meet at least 3 of the 5 criteria for metabolic syndrome as per NCEP guidelinesWHO guidelines and who do not have known cardiovascular disease or diabetes They will receive either placebo or omega-3 fatty acids in the form of fish oil capsules for a two-year period Assessment of C-IMT serum lipoprotein profile LDL- buoyancy adiponectin CRP SAA apolipoprotein B and A-1 fasting glucose fasting insulin levels and plasma fatty acids will be measured at baseline one year and two years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 05-8693-D 03 | None | None | None |