Metabolic Syndrome XEarly Phase 1NCT00350194
The Effects of Omega-3 Fatty Acids on Metabolic Syndrome
A Early Phase 1 study testing Omega-3 fatty acids in people with Metabolic Syndrome X, run by University of Washington at 1 site in United States.
Trial 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 (CIMT)progression (primary objective) and 2)(Secondary objective) lipid markers such as LDL, apo-B, and LDL buoyancy, on inflammatory burden… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolic Syndrome X
- What is being tested?
- Omega-3 fatty acids
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2006to Jun 2012
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults with Metabolic Syndrome (meets 3 of the following 5)
- Abdominal obesity, waist circumference in men greater than 40 in. \& in women greater than 35 in.
- Serum triglycerides greater than or = 150 mg/dL (1.7 mmol/L)
- Serum HDL cholesterol less than or = 40 mg/dL in men and less than 50 mg/dL in women
- Blood pressure greater than or = 130/85 mmHg or drug treatment for elevated blood pressure
- Fasting plasma glucose greater than 100 mg/dL
Who cannot join
- Diabetes
- Known or documented CHD (including ECG consistent with prior MI), CVA (including TIA), PVD (including symptoms of claudication)
- Angina or other chest pain that may indicate CHD
- Clinically significant neoplastic, cardiovascular, hepatic, renal, metabolic, endocrine (untreated or unstable), or psychiatric (untreated or unstable)
- Known abnormal LFTS greater than 2X ULN
- Smoker, illicit drug use, or excessive alcohol use
Show all 9Show fewer
- Medications: Lipid lowering therapy, daily NSAID or greater than 325 mg ASA (PRN use ok), clopidogrel (or equivalent), Coumadin, Omega-3 fatty acid supplement, other investigational drugs within 30 days of study entry, high omega-3 fatty acid content in diet within past three months
- Pregnancy or planning pregnancy during the study period
- Sensitivity or allergy to fish
Trial locations and contacts
1 site in 1 country.
United States1 site
Northwest Lipid Research Clinic (University of Washington Affiliated)
Seattle, Washington, 98104
About this study
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
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 (CIMT)progression (primary objective) and 2)(Secondary 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 microalbumin/creatinine, and serum adiponectin a fat derived hormone in subjects with metabolic syndrome.
Read the 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 guidelines/WHO 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.
- Conditions
- Metabolic Syndrome X
- Being tested
- Omega-3 fatty acids
- Keywords
- Fatty Acids, Omega-3
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omega-3 fatty acidsDietary supplement
Also called Fish Oil
Total of 1.8 grams of EPA +DHA in the form of fish oil capsules (3/day)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | Omega-3 fatty acid vs. placebo comparator Receives: Dietary Supplement: Omega-3 fatty acids |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Carotid IMT
Measured: 1 year, 2 years
Secondary outcomes (7)
Lipid (apolipoproteins and lipid parameters)
Measured: 1 year, 2 years
hs-CRP & SAA
Measured: 1 year, 2 years
Glucose
Measured: 1 year, 2 years
Insulin
Measured: 1 year, 2 years
adiponectin
Measured: 1 year, 2 years
urine microalbumin/creatinine
Measured: 1 year, 2 years
Serum Fatty Acids
Measured: 1 year, 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2006 (estimated)
- Study startOct 2006
- Primary completionOct 2011
- Study completionJun 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic Syndrome XStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer, National Institutes of Health (NIH), Northwest Lipid Research Clinic
- Responsible party
- Principal investigator, Pathmaja Paramsothy, University of Washington
- Investigators
- Pathmaja Paramsothy, MD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00350194
- Sponsor's protocol ID
- 28791-D
- Other IDs
- 05-8693-D 03
- Status last verified
- Feb 2012
- First submitted
- 6 Jul 2006
- Last updated
- 2 Mar 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00350194
- Acronym / sponsor ID
- 28791-D
- Conditions
- Metabolic Syndrome X
- Keywords
- Fatty Acids, Omega-3
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- Pfizer, National Institutes of Health (NIH), Northwest Lipid Research Clinic
- Study start
- Oct 2006
- Primary completion
- Oct 2011 (actual)
- Study completion
- Jun 2012 (estimated)
- First posted
- 10 Jul 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 (CIMT)progression (primary objective) and 2)(Secondary 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 microalbumin/creatinine, 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 guidelines/WHO 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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Dietary Supplement: Omega-3 fatty acidsOmega-3 fatty acid vs. placebo comparator |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adults with Metabolic Syndrome (meets 3 of the following 5)
- Abdominal obesity, waist circumference in men greater than 40 in. \& in women greater than 35 in.
- Serum triglycerides greater than or = 150 mg/dL (1.7 mmol/L)
- Serum HDL cholesterol less than or = 40 mg/dL in men and less than 50 mg/dL in women
- Blood pressure greater than or = 130/85 mmHg or drug treatment for elevated blood pressure
Key exclusion criteria (9 listed)
- Diabetes
- Known or documented CHD (including ECG consistent with prior MI), CVA (including TIA), PVD (including symptoms of claudication)
- Angina or other chest pain that may indicate CHD
- Clinically significant neoplastic, cardiovascular, hepatic, renal, metabolic, endocrine (untreated or unstable), or psychiatric (untreated or unstable)
- Known abnormal LFTS greater than 2X ULN
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Omega-3 fatty acidsAlso: Fish OilTotal of 1.8 grams of EPA +DHA in the form of fish oil capsules (3/day) | Dietary supplement | 1 |
Primary outcome
Change in Carotid IMT
Time frame: 1 year, 2 years
7 secondary outcomes
Lipid (apolipoproteins and lipid parameters)
Time frame: 1 year, 2 years
hs-CRP & SAA
Time frame: 1 year, 2 years
Glucose
Time frame: 1 year, 2 years
Insulin
Time frame: 1 year, 2 years
adiponectin
Time frame: 1 year, 2 years
urine microalbumin/creatinine
Time frame: 1 year, 2 years
Serum Fatty Acids
Time frame: 1 year, 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pathmaja Paramsothy, MD principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Omega-3 fatty acids in people with Metabolic Syndrome X, run by University of Washington at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Carotid IMT (time frame: 1 year, 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2012.