Endothelial DysfunctionPhase 2BedrestNCT01412216
The Effects of Sedentarism on Vascular Function, Inflammation, and Insulin Resistance
A Phase 2 study testing Fish Oil (Omega-3 Fatty Acids) in people with Endothelial Dysfunction and Insulin Resistance, run by University of California, San Francisco at 1 site in United States.
Trial summary
The purpose of this study are twofold: 1. To understand the effects of physical inactivity (sedentarism) on vascular function, insulin resistance and inflammation; 2. To assess the role of a dietary intervention (fish oil) in counteracting the effects of physical inactivity on vascular function and inflammation. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Endothelial Dysfunction, Insulin Resistance, Metabolic Syndrome
- What is being tested?
- Fish Oil (Omega-3 Fatty Acids)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2011to Nov 2013
- Phase
- Phase 2
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy subjects: Subjects must be free from any acute, chronic or debilitating medical conditions. Healthy status will be established on the basis of clinical history, electrocardiogram, clinical biochemical screening tests of blood and urine, a physical examination, and where necessary a chest radiograph.
Who cannot join
- Any active acute or chronic medical problem: Any subject with symptoms of active illness (e.g., fever, leukocytosis, hypertension) will be excluded from study. The exclusion criteria will also include history or evidence for psychiatric disorders, hypertension, diabetes, coronary artery disease (CAD), renal insufficiency, thyroid disease, alcohol or drug abuse, viral hepatitis, deep venous thrombosis or anemia. Individuals with a history of psychiatric illnesses or psychiatric disorders will also be excluded, such as alcoholism, drug dependency including dependency on tobacco, major mood disorders such as major depression and manic depressive illness, schizophrenic disorders, anxiety disorders including panic disorder, generalized anxiety disorder, post traumatic stress disorder, obsessive compulsive disorder, agoraphobia, claustrophobia, paranoid personality disorder, schizoid personality disorder, schizotypal personality disorder, borderline personality disorder, and antisocial personality disorder. In addition, potential subjects with a first order relative with a history of major depressive illness, manic depressive illness, schizophrenia, agoraphobia or panic disorder will also be excluded from entry to this study. Finally, individuals who are unaware of specific psychiatric diagnoses who have a history of having been treated with antidepressant, neuroleptic medications or major tranquilizers will be excluded from study. However, a personal history of limited prior counseling or psychotherapy (e.g., for adjustment reactions) will not necessarily be exclusionary.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California San Francisco
San Francisco, California
About this study
The purpose of this study are twofold:
- To understand the effects of physical inactivity (sedentarism) on vascular function, insulin resistance and inflammation;
- To assess the role of a dietary intervention (fish oil) in counteracting the effects of physical inactivity on vascular function and inflammation.
- Conditions
- Endothelial Dysfunction, Insulin Resistance, Metabolic Syndrome, Peripheral Arterial Disease
- Being tested
- Fish Oil (Omega-3 Fatty Acids)
- Keywords
- Sedentarism, Physical inactivity, Fish oil, Omega-3 fatty acids, Endothelial dysfunction, Insulin resistance, Metabolic syndrome, peripheral arterial disease
- Medical subject headings
- Insulin Resistance, Metabolic Syndrome, Peripheral Arterial Disease, Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fish Oil (Omega-3 Fatty Acids)Dietary supplement
fish oil-4.4gm/day x 5 days
Fish Oil (Omega-3 Fatty Acids)Dietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Fish Oil (Omega-3 Fatty Acids) | Experimental | High-dose, short-duration dietary omega-3 fatty acids supplementation Receives: Dietary Supplement: Fish Oil (Omega-3 Fatty Acids) |
| Placebo | Placebo comparator | Placebo control Receives: Dietary Supplement: Fish Oil (Omega-3 Fatty Acids) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endothelial Function
Flow-mediated, brachial artery vasodilation (FMD)
Measured: 5 days
Secondary outcomes (1)
Insulin Resistance
The homeostatic model assessment (HOMA) method used to quantify insulin resistance (HOMA-IR)
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2011 (estimated)
- Study startSep 2011
- Primary completionNov 2013
- Study completionNov 2013
Why it stopped: Funding Depleted.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endothelial DysfunctionStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marlene Grenon, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01412216
- Sponsor's protocol ID
- Sedentarism
- Acronym
- Bedrest
- Status last verified
- Nov 2013
- First submitted
- 5 Aug 2011
- Last updated
- 7 Nov 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Sedentarism on Vascular Function, Inflammation, and Insulin Resistance
- ClinicalTrials.gov ID
- NCT01412216
- Acronym / sponsor ID
- Bedrest / Sedentarism
- Conditions
- Endothelial Dysfunction, Insulin Resistance, Metabolic Syndrome, Peripheral Arterial Disease
- Keywords
- Sedentarism, Physical inactivity, Fish oil, Omega-3 fatty acids, Endothelial dysfunction, Insulin resistance, Metabolic syndrome, peripheral arterial disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Funding Depleted.
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 9 Aug 2011 (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 are twofold:
- To understand the effects of physical inactivity (sedentarism) on vascular function, insulin resistance and inflammation;
- To assess the role of a dietary intervention (fish oil) in counteracting the effects of physical inactivity on vascular function and inflammation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fish Oil (Omega-3 Fatty Acids) | Experimental | Dietary Supplement: Fish Oil (Omega-3 Fatty Acids)High-dose, short-duration dietary omega-3 fatty acids supplementation |
| Placebo | Placebo comparator | Dietary Supplement: Fish Oil (Omega-3 Fatty Acids)Placebo control |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy subjects: Subjects must be free from any acute, chronic or debilitating medical conditions. Healthy status will be established on the basis of clinical history, electrocardiogram, clinical biochemical screening tests of blood and urine, a physical examination, and where necessary a chest radiograph.
Key exclusion criteria (1 listed)
- Any active acute or chronic medical problem: Any subject with symptoms of active illness (e.g., fever, leukocytosis, hypertension) will be excluded from study. The exclusion criteria will also include history or evidence for psychiatric disorders, hypertension, diabetes, coronary artery disease (CAD), renal insufficiency, thyroid disease, alcohol or drug abuse, viral hepatitis, deep venous thrombosis or anemia. Individuals with a history of psychiatric illnesses or psychiatric disorders will also be excluded, such as alcoholism, drug dependency including dependency on tobacco, major mood disorders such as major depression and manic depressive illness, schizophrenic disorders, anxiety disorders including panic disorder, generalized anxiety disorder, post traumatic stress disorder, obsessive compulsive disorder, agoraphobia, claustrophobia, paranoid personality disorder, schizoid personality disorder, schizotypal personality disorder, borderline personality disorder, and antisocial personality disorder. In addition, potential subjects with a first order relative with a history of major depressive illness, manic depressive illness, schizophrenia, agoraphobia or panic disorder will also be excluded from entry to this study. Finally, individuals who are unaware of specific psychiatric diagnoses who have a history of having been treated with antidepressant, neuroleptic medications or major tranquilizers will be excluded from study. However, a personal history of limited prior counseling or psychotherapy (e.g., for adjustment reactions) will not necessarily be exclusionary.
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 |
|---|---|---|
| Fish Oil (Omega-3 Fatty Acids)fish oil-4.4gm/day x 5 days | Dietary supplement | Fish Oil (Omega-3 Fatty Acids) |
| Fish Oil (Omega-3 Fatty Acids) | Dietary supplement | Placebo |
Primary outcome
Endothelial Function
Time frame: 5 days
Flow-mediated, brachial artery vasodilation (FMD)
1 secondary outcome
Insulin Resistance
Time frame: 5 days
Results and safety
The study was stopped early (reason given: Funding Depleted.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2013.
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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.
Marlene Grenon, MD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fish Oil (Omega-3 Fatty Acids) in people with Endothelial Dysfunction and Insulin Resistance, run by University of California, San Francisco 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 1 inclusion and 1 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: stopped early, as of the sponsor's last update on 7 Nov 2013. 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?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Funding Depleted.). 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?
Endothelial Function (time frame: 5 days). 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 7 Nov 2013.