ObesityNCT00184899
The Potential Role for Adenosine in the Haemodynamic Effects of Free Fatty Acids
A study testing Intravenous infusion of Intralipid/heparin and Intravenous infusion of Glycerol/heparin in people with Obesity and Metabolic Syndrome X, run by Radboud University Medical Center at 1 site in Netherlands.
Trial summary
The metabolic syndrome is associated with hyperdynamic circulation and sympathetic activation. Recently, Bakker et al. (Atherosclerosis 2002) described the hypothesis that free fatty acids are responsible for this association. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Metabolic Syndrome X
- What is being tested?
- Intravenous infusion of Intralipid/heparin and Intravenous infusion of Glycerol/heparin
- Type of treatment
- Injection or infusion
- How many people
- 20 participants
- Where
- 1 siteNetherlands
- Study dates
- Aug 2005to Aug 2006
- Phase
- Interventional
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy volunteers
Who cannot join
- Pregnancy
- Asthma
- Use of medication
- Cardiovascular/pulmonary disease and diabetes
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Radboud University Nijmegen Medical Centre
Nijmegen, 6500HB
About this study
The metabolic syndrome is associated with hyperdynamic circulation and sympathetic activation. Recently, Bakker et al. (Atherosclerosis 2002) described the hypothesis that free fatty acids are responsible for this association. The investigators hypothesize that in patients with obesity and the metabolic syndrome, an increased intracellular concentration of long-chain fatty acyl (LCFA)-CoA (the intracellular equivalent of free fatty acids) induces an increase in adenosine. Adenosine receptor stimulation, in turn, induces vasodilation and sympathetic activation.
The investigators aimed to assess this effect of free fatty acids on the adenosine system in healthy volunteers.
- Conditions
- Obesity, Metabolic Syndrome X
- Being tested
- Intravenous infusion of Intralipid/heparin, Intravenous infusion of Glycerol/heparin
- Keywords
- free fatty acids, vasodilation, sympathetic activity
- Medical subject headings
- Obesity, Metabolic Syndrome, Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous infusion of Intralipid/heparinDrug
Intravenous infusion of Glycerol/heparinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Forearm blood flow
Vasoactive effect of caffeine
Sympathetic activity (noradrenaline spillover, spectral analysis)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startAug 2005
- Study completionAug 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe 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 N/A
- Primary purpose
- Early clinical test
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Enrolment
- 20 participants
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Investigators
- Paul Smits, MD, PhD, Principal investigator, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00184899
- Sponsor's protocol ID
- Intralipid-Ado
- Other IDs
- ZonMw Nr. 920-03-249
- Status last verified
- Feb 2007
- First submitted
- 12 Sep 2005
- Last updated
- 1 Mar 2007
- Results posted
- No
Publications
Bakker SJ, Gans RO, ter Maaten JC, Teerlink T, Westerhoff HV, Heine RJ. The potential role of adenosine in the pathophysiology of the insulin resistance syndrome. Atherosclerosis. 2001 Apr;155(2):283-90. doi: 10.1016/s0021-9150(00)00745-0.
PubMed 11254897
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Potential Role for Adenosine in the Haemodynamic Effects of Free Fatty Acids
- ClinicalTrials.gov ID
- NCT00184899
- Acronym / sponsor ID
- Intralipid-Ado
- Conditions
- Obesity, Metabolic Syndrome X
- Keywords
- free fatty acids, vasodilation, sympathetic activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Study start
- Aug 2005
- Study completion
- Aug 2006
- First posted
- 16 Sep 2005 (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 metabolic syndrome is associated with hyperdynamic circulation and sympathetic activation. Recently, Bakker et al. (Atherosclerosis 2002) described the hypothesis that free fatty acids are responsible for this association. The investigators hypothesize that in patients with obesity and the metabolic syndrome, an increased intracellular concentration of long-chain fatty acyl (LCFA)-CoA (the intracellular equivalent of free fatty acids) induces an increase in adenosine. Adenosine receptor stimulation, in turn, induces vasodilation and sympathetic activation.
The investigators aimed to assess this effect of free fatty acids on the adenosine system in healthy volunteers.
Study design
- Primary purpose
- Early clinical test
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy volunteers
Key exclusion criteria (4 listed)
- Pregnancy
- Asthma
- Use of medication
- Cardiovascular/pulmonary disease and diabetes
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 |
|---|---|---|
| Intravenous infusion of Intralipid/heparin | Drug | – |
| Intravenous infusion of Glycerol/heparin | Drug | – |
Primary outcome
Forearm blood flow
Vasoactive effect of caffeine
Sympathetic activity (noradrenaline spillover, spectral analysis)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2007.
- Background: PubMed 11254897Bakker SJ, Gans RO, ter Maaten JC, Teerlink T, Westerhoff HV, Heine RJ. The potential role of adenosine in the pathophysiology of the insulin resistance syndrome. Atherosclerosis. 2001 Apr;155(2):283-90. doi: 10.1016/s0021-9150(00)00745-0.
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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.
Paul Smits, MD, PhD principal investigator
Radboud University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intravenous infusion of Intralipid/heparin and Intravenous infusion of Glycerol/heparin in people with Obesity and Metabolic Syndrome X, run by Radboud University Medical Center at 1 site in Netherlands.
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 4 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 1 Mar 2007. 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 Netherlands. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Forearm blood flow. The study lists 3 primary outcomes in all. 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 NCT00184899, which also lists 1 linked publication.
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 1 Mar 2007.