HealthyNCT00929136
Peripheral Effects of Endotoxin on Insulin Resistance
A study testing USP endotoxin in people with Healthy, run by Aarhus University Hospital at 1 site in Denmark.
Trial summary
The aim of the study is to isolate the direct effects of endotoxin on glucose, lipid and protein metabolism. Eight healthy volunteers are enrolled. The hypothesis is that endotoxin will induce insulin resistance, lypolysis and proteolysis acutely. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- USP endotoxin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteDenmark
- Study dates
- Jun 2009to May 2010
- 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 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Normal health
- 22 < BMI < 28
- Written Informed Concent
Who cannot join
- Any disease
- Any use of medication
- Recent immobilization of a lower extremity
Trial locations and contacts
1 site in 1 country.
Denmark1 site
The Medical Research Laboratories, Dept. M, Aarhus University Hospital
Aarhus, 8000
About this study
Official title: The Effect of Regional Inflammation on Metabolism and Insulin Sensitivity in the Lower Extremity.
The aim of the study is to isolate the direct effects of endotoxin on glucose, lipid and protein metabolism. Eight healthy volunteers are enrolled. The hypothesis is that endotoxin will induce insulin resistance, lypolysis and proteolysis acutely.
- Conditions
- Healthy
- Being tested
- USP endotoxin
- Keywords
- Endotoxin, Insulin resistance, Lipolysis, Proteolysis, Intracellular Insulin Signaling, Regional effects of inflammation/endotoxin
- Medical subject headings
- Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
USP endotoxinBiological
Also called USP Endotoxin, LOT: G3E069
Continuous intra-arterial infusion
| Study group | Role | What they receive |
|---|---|---|
| Endotoxin | Experimental | Not described Receives: Biological: USP endotoxin |
What is being measured
The primary outcome is the main question the study is designed to answer.
glucose concentration
Measured: 360 minutes observation
Secondary outcomes (3)
Regional arteriovenous amino-acid balance
Measured: measured at t=180 and 360 minutes
Intra-cellular insulin signaling
Measured: measured at t=0, 120, and, 210 minutes
Regional arteriovenous lipid balance
Measured: measured at t=180 and 360 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2009 (estimated)
- Study startJun 2009
- Primary completionMay 2010
- Study completionMay 2010
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 HealthyStudies of the same condition, open and under way.
- More trials run by Aarhus University 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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 8 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aarhus University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Mads Buhl, M.D., Principal investigator, Medical Department M (Endocrinology and Diabetes), Århus University Hospital, DenmarkNiels Moller, M.D., professor, Dmsc, Study director, Medical Department M (Endocrinology and Diabetes), Aarhus University Hospital, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00929136
- Sponsor's protocol ID
- Aarhus University Hospital
- Status last verified
- Oct 2010
- First submitted
- 22 Jun 2009
- Last updated
- 4 Oct 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Buhl M, Bosnjak E, Vendelbo MH, Gjedsted J, Nielsen RR, K-Hafstrom T, Vestergaard ET, Jessen N, Tonnesen E, Moller AB, Pedersen SB, Pilegaard H, Bienso RS, Jorgensen JO, Moller N. Direct effects of locally administered lipopolysaccharide on glucose, lipid, and protein metabolism in the placebo-controlled, bilaterally infused human leg. J Clin Endocrinol Metab. 2013 May;98(5):2090-9. doi: 10.1210/jc.2012-3836. Epub 2013 Mar 29.
PubMed 23543661
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Regional Inflammation on Metabolism and Insulin Sensitivity in the Lower Extremity.
- ClinicalTrials.gov ID
- NCT00929136
- Acronym / sponsor ID
- Aarhus University Hospital
- Conditions
- Healthy
- Keywords
- Endotoxin, Insulin resistance, Lipolysis, Proteolysis, Intracellular Insulin Signaling, Regional effects of inflammation/endotoxin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- Aarhus University HospitalUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 26 Jun 2009 (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 aim of the study is to isolate the direct effects of endotoxin on glucose, lipid and protein metabolism. Eight healthy volunteers are enrolled. The hypothesis is that endotoxin will induce insulin resistance, lypolysis and proteolysis acutely.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Endotoxin | Experimental | Biological: USP endotoxin |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Normal health
- 22 < BMI < 28
- Written Informed Concent
Key exclusion criteria (3 listed)
- Any disease
- Any use of medication
- Recent immobilization of a lower extremity
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 |
|---|---|---|
| USP endotoxinAlso: USP Endotoxin, LOT: G3E069Continuous intra-arterial infusion | Biological | Endotoxin |
Primary outcome
glucose concentration
Time frame: 360 minutes observation
3 secondary outcomes
Regional arteriovenous amino-acid balance
Time frame: measured at t=180 and 360 minutes
Intra-cellular insulin signaling
Time frame: measured at t=0, 120, and, 210 minutes
Regional arteriovenous lipid balance
Time frame: measured at t=180 and 360 minutes
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 4 Oct 2010.
- Derived from this study: PubMed 23543661Buhl M, Bosnjak E, Vendelbo MH, Gjedsted J, Nielsen RR, K-Hafstrom T, Vestergaard ET, Jessen N, Tonnesen E, Moller AB, Pedersen SB, Pilegaard H, Bienso RS, Jorgensen JO, Moller N. Direct effects of locally administered lipopolysaccharide on glucose, lipid, and protein metabolism in the placebo-controlled, bilaterally infused human leg. J Clin Endocrinol Metab. 2013 May;98(5):2090-9. doi: 10.1210/jc.2012-3836. Epub 2013 Mar 29.
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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.
Mads Buhl, M.D. principal investigator
Medical Department M (Endocrinology and Diabetes), Århus University Hospital, Denmark
Niels Moller, M.D., professor, Dmsc study director
Medical Department M (Endocrinology and Diabetes), Aarhus University Hospital, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing USP endotoxin in people with Healthy, run by Aarhus University Hospital at 1 site in Denmark.
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 3 inclusion and 3 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 4 Oct 2010. 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 Denmark. 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?
glucose concentration (time frame: 360 minutes observation). 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 NCT00929136, 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 4 Oct 2010.