Metabolic SyndromePhase 2/3NCT00759291
The Impact of Free Fatty Acid Reduction on Vascular Function in the Metabolic Syndrome
A Phase 2/3 study testing acipimox in people with Metabolic Syndrome, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
This study will test the hypothesis that reducing the release of free fatty acids (FFA) from fat cells will restore insulin-mediated, endothelium-dependent vasodilation in people with the metabolic syndrome. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Metabolic Syndrome
- What is being tested?
- acipimox
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2006to 30 Dec 2017
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults with metabolic syndrome, defined as the presence of 3 of 5 components of the syndrome as defined by the National Cholesterol Education Program including:
- abdominal obesity
- elevated fasting blood sugar (110 mg/dL< glucose < 126 mg/dL)
- low HDL
- elevated fasting blood triglycerides (> 150 mg/dL)
- hypertension (BP > 140/90 mm HG)
- Normal cardiovascular examination
Who cannot join
- Diabetes mellitus
- Untreated hypercholesterolemia (LDL > 75th percentile for age)
- Cigarette smoking within 1 year
- Renal insufficiency (creatinine > 1.4 mg/dl)
- Blood dyscrasia
- Hepatic dysfunction (ALT > 2x normal)
- Evident coronary/peripheral atherosclerosis
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
This study will test the hypothesis that reducing the release of free fatty acids (FFA) from fat cells will restore insulin-mediated, endothelium-dependent vasodilation in people with the metabolic syndrome.
Read the detailed description
We hypothesize that acipimox, by decreasing plasma FFA concentrations, will augment endothelium-dependent vasodilation in conduit vessels and insulin-mediated vasodilation in forearm resistance arterioles in vivo, whole-body insulin sensitivity, and AKT (also known as Protein Kinase B) and endothelial nitric oxide synthase (eNOS) phosphorylation in skin biopsy specimens ex vivo, when compared with placebo.
- Conditions
- Metabolic Syndrome
- Being tested
- acipimox, Placebo
- Keywords
- free fatty acids, insulin-mediated, endothelium-dependent vasodilation, metabolic syndrome
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acipimoxDrug
Also called Olbetam
250 mg tablet orally every 6 hours for 7 days, with a dose at 7 am on the morning of the study visit
PlaceboDrug
1 tablet orally every 6 hours for 7 days, with a dose at 7 am on the morning of the study visit
| Study group | Role | What they receive |
|---|---|---|
| Acipimox | Active comparator | Acipimox treatment QID for 7 days Receives: Drug: acipimox |
| Placebo | Placebo comparator | Placebo treatment QID for 7 days Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Flow Mediated Vasodilation
Brachial artery response to a 5 minute blood pressure cuff-applied ischemic period
Measured: After 7 days of each treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2008 (estimated)
- Study start1 Apr 2006
- Primary completion1 Dec 2017
- Study completion30 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe 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 2/3
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joshua A. Beckman, MD, Brigham and Women's Hospital
- Investigators
- Joshua A. Beckman, M.D., Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00759291
- Sponsor's protocol ID
- 2005P-001861
- Status last verified
- Feb 2023
- First submitted
- 24 Sep 2008
- Last updated
- 21 Feb 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Aday AW, Goldfine AB, Gregory JM, Beckman JA. Impact of Acipimox Therapy on Free Fatty Acid Efflux and Endothelial Function in the Metabolic Syndrome: A Randomized Trial. Obesity (Silver Spring). 2019 Nov;27(11):1812-1819. doi: 10.1002/oby.22602. Epub 2019 Oct 1.
PubMed 31571412Sullivan AE, Courvan MCS, Ada AW, Wasserman DH, Niswender KD, Shardelow EM, Wells EK, Wells QS, Freiberg MS, Beckman JA. The Role of Serum Free Fatty Acids in Endothelium-Dependent Microvascular Function. Endocrinol Diabetes Metab. 2025 Mar;8(2):e70031. doi: 10.1002/edm2.70031.
PubMed 39888728
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Free Fatty Acid Reduction on Vascular Function in the Metabolic Syndrome
- ClinicalTrials.gov ID
- NCT00759291
- Acronym / sponsor ID
- 2005P-001861
- Conditions
- Metabolic Syndrome
- Keywords
- free fatty acids, insulin-mediated, endothelium-dependent vasodilation, metabolic syndrome
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- 1 Apr 2006 (actual)
- Primary completion
- 1 Dec 2017 (actual)
- Study completion
- 30 Dec 2017 (actual)
- First posted
- 25 Sep 2008 (estimated)
- Results
- Posted 21 Feb 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will test the hypothesis that reducing the release of free fatty acids (FFA) from fat cells will restore insulin-mediated, endothelium-dependent vasodilation in people with the metabolic syndrome.
Detailed description
We hypothesize that acipimox, by decreasing plasma FFA concentrations, will augment endothelium-dependent vasodilation in conduit vessels and insulin-mediated vasodilation in forearm resistance arterioles in vivo, whole-body insulin sensitivity, and AKT (also known as Protein Kinase B) and endothelial nitric oxide synthase (eNOS) phosphorylation in skin biopsy specimens ex vivo, when compared with placebo.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acipimox | Active comparator | Drug: acipimoxAcipimox treatment QID for 7 days |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo treatment QID for 7 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adults with metabolic syndrome, defined as the presence of 3 of 5 components of the syndrome as defined by the National Cholesterol Education Program including:
- Normal cardiovascular examination
Key exclusion criteria (7 listed)
- Diabetes mellitus
- Untreated hypercholesterolemia (LDL > 75th percentile for age)
- Cigarette smoking within 1 year
- Renal insufficiency (creatinine > 1.4 mg/dl)
- Blood dyscrasia
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 |
|---|---|---|
| acipimoxAlso: Olbetam250 mg tablet orally every 6 hours for 7 days, with a dose at 7 am on the morning of the study visit | Drug | Acipimox |
| Placebo1 tablet orally every 6 hours for 7 days, with a dose at 7 am on the morning of the study visit | Drug | Placebo |
Primary outcome
Flow Mediated Vasodilation
Time frame: After 7 days of each treatment.
Brachial artery response to a 5 minute blood pressure cuff-applied ischemic period
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 31571412Aday AW, Goldfine AB, Gregory JM, Beckman JA. Impact of Acipimox Therapy on Free Fatty Acid Efflux and Endothelial Function in the Metabolic Syndrome: A Randomized Trial. Obesity (Silver Spring). 2019 Nov;27(11):1812-1819. doi: 10.1002/oby.22602. Epub 2019 Oct 1.
- Derived from this study: PubMed 39888728Sullivan AE, Courvan MCS, Ada AW, Wasserman DH, Niswender KD, Shardelow EM, Wells EK, Wells QS, Freiberg MS, Beckman JA. The Role of Serum Free Fatty Acids in Endothelium-Dependent Microvascular Function. Endocrinol Diabetes Metab. 2025 Mar;8(2):e70031. doi: 10.1002/edm2.70031.
- Individual participant dataSharing planned: No
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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.
Joshua A. Beckman, M.D. principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing acipimox in people with Metabolic Syndrome, run by Brigham and Women's Hospital 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 7 inclusion and 7 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: finished, as of the sponsor's last update on 21 Feb 2023. 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Feb 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Flow Mediated Vasodilation (time frame: After 7 days of each treatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00759291, which also lists 2 linked publications.
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 21 Feb 2023.