Healthy ControlsPhase 1NCT00771940
Peripheral Metabolic Effects of Ghrelin
A Phase 1 study testing Ghrelin in people with Healthy Controls, run by University of Aarhus at 1 site in Denmark.
Trial summary
The aim of this study is to investigate putative peripheral effects of ghrelin on glucose and lipid metabolism in healthy men. Eight subjects will be enrolled. The hypothesis is that ghrelin infusion causes insulin resistance and lipolysis. Read more about this study
- Who is it for?
- Ages 18 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Controls
- What is being tested?
- Ghrelin
- 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
- Oct 2008to Jan 2009
- Phase
- 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 60 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI < 27 kg/m2
- Written informed consent
- Non-smoker
Who cannot join
- Any disease including epilepsy
- Any use of medications (excl. paracetamol)
- Present or previous malignancy
- Alcohol dependency
- Allergy to any trial medication
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Peripheral Metabolic Effects of Intra Arterial Ghrelin Infusion in Healthy Controls
The aim of this study is to investigate putative peripheral effects of ghrelin on glucose and lipid metabolism in healthy men. Eight subjects will be enrolled. The hypothesis is that ghrelin infusion causes insulin resistance and lipolysis.
- Conditions
- Healthy Controls
- Being tested
- Ghrelin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GhrelinDrug
Solvent, cont. infusion
| Study group | Role | What they receive |
|---|---|---|
| Ghrelin | Active comparator | Not described Receives: Drug: Ghrelin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma levels of glucose
Measured: During study day
Secondary outcomes (2)
Insulin signaling
Measured: Study day
Serum levels of fatty acids
Measured: Study day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2008 (estimated)
- Study startOct 2008
- Primary completionJan 2009
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ControlsStudies of the same condition, open and under way.
- More trials run by University of AarhusThe 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 1
- 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
- University of Aarhus
- Sponsor type
- University, hospital or other
- Investigators
- Jens Otto L. Jorgensen, MD, Study director, Medical Department M, Aarhus University Horpital, DenmarkEsben T Vestergaard, PhD, Principal investigator, Medical Department M, Aarhus University Hospital, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00771940
- Sponsor's protocol ID
- M-2007008
- Status last verified
- Feb 2009
- First submitted
- 8 Oct 2008
- Last updated
- 3 Feb 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peripheral Metabolic Effects of Intra Arterial Ghrelin Infusion in Healthy Controls
- ClinicalTrials.gov ID
- NCT00771940
- Acronym / sponsor ID
- M-2007008
- Conditions
- Healthy Controls
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- Oct 2008
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 15 Oct 2008 (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 this study is to investigate putative peripheral effects of ghrelin on glucose and lipid metabolism in healthy men. Eight subjects will be enrolled. The hypothesis is that ghrelin infusion causes insulin resistance and lipolysis.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ghrelin | Active comparator | Drug: Ghrelin |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- BMI < 27 kg/m2
- Written informed consent
- Non-smoker
Key exclusion criteria (5 listed)
- Any disease including epilepsy
- Any use of medications (excl. paracetamol)
- Present or previous malignancy
- Alcohol dependency
- Allergy to any trial medication
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 |
|---|---|---|
| GhrelinSolvent, cont. infusion | Drug | Ghrelin |
Primary outcome
Plasma levels of glucose
Time frame: During study day
2 secondary outcomes
Insulin signaling
Time frame: Study day
Serum levels of fatty acids
Time frame: Study day
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 3 Feb 2009.
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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.
Jens Otto L. Jorgensen, MD study director
Medical Department M, Aarhus University Horpital, Denmark
Esben T Vestergaard, PhD principal investigator
Medical Department M, 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 Phase 1 study testing Ghrelin in people with Healthy Controls, run by University of Aarhus 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 5 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 3 Feb 2009. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 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?
Plasma levels of glucose (time frame: During study day). 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 3 Feb 2009.