HealthyEarly Phase 1NCT01595373
Local Metabolic Effects of Ghrelin in Skeletal Muscle and Adipose Tissue
A Early Phase 1 study testing Acyl ghrelin in people with Healthy, run by Esben Thyssen Vestergaard at 1 site in Denmark.
Trial summary
The metabolic effects of ghrelin is investigated by microdialysis technique. Subjects are healthy young men. End points are interstitial concentrations of glucose, lactate, and glycerol. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Acyl ghrelin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteDenmark
- Study dates
- Jun 2012to Jan 2013
- Phase
- Early 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 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- healthy male
- age 18-65 years (included)
- Body mass index 20-25 (included)
Who cannot join
- alcohol abuse
- malignant disease
- use of any medicine except otc painkillers
- any disease recognized
- participation in a trial using radioactive isotopes within the last 6 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Local Metabolic Effects of Ghrelin: A Clinical Microdialysis Study
The metabolic effects of ghrelin is investigated by microdialysis technique. Subjects are healthy young men. End points are interstitial concentrations of glucose, lactate, and glycerol.
- Conditions
- Healthy
- Being tested
- Acyl ghrelin, Placebo (Ringer acetate)
- Keywords
- Ghrelin, Microdialysis, Controls, Metabolic effects of ghrelin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acyl ghrelinDrug
Also called Human acyl ghrelin, Ghrelin
Acyl ghrelin 12.5 pg/min infused continuously for 300 minutes
Placebo (Ringer acetate)Drug
Ringer acetate 2 microliter/min for 300 minutes
| Study group | Role | What they receive |
|---|---|---|
| Ghrelin | Active comparator | Ghrelin Receives: Drug: Acyl ghrelin |
| Placebo | Placebo comparator | Ringer acetate is used for placebo. Receives: Drug: Placebo (Ringer acetate) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Interstitial concentrations of glycerol
Measured: Interstitial concentrations of glycerol at t=120 minutes
Secondary outcomes (2)
Interstitial concentrations of lactate
Measured: Interstitial concentrations of lactate at t=120 minutes
Interstitial concentrations of glucose
Measured: Interstitial concentrations of glucose at t=120 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2012 (estimated)
- Study startJun 2012
- Primary completionSep 2012
- Study completionJan 2013
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.
- 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
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Esben Thyssen Vestergaard
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Esben Thyssen Vestergaard, University of Aarhus
- Investigators
- Esben T. Vestergaard, MD PhD, Principal investigator, University of Aarhus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01595373
- Sponsor's protocol ID
- 2012-28512
- Status last verified
- Jan 2013
- First submitted
- 7 May 2012
- Last updated
- 16 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Vestergaard ET, Moller N, Jorgensen JO. Acute peripheral tissue effects of ghrelin on interstitial levels of glucose, glycerol, and lactate: a microdialysis study in healthy human subjects. Am J Physiol Endocrinol Metab. 2013 Jun 15;304(12):E1273-80. doi: 10.1152/ajpendo.00662.2012. Epub 2013 Apr 16.
PubMed 23592479
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Local Metabolic Effects of Ghrelin: A Clinical Microdialysis Study
- ClinicalTrials.gov ID
- NCT01595373
- Acronym / sponsor ID
- 2012-28512
- Conditions
- Healthy
- Keywords
- Ghrelin, Microdialysis, Controls, Metabolic effects of ghrelin
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Esben Thyssen VestergaardUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Sep 2012 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 10 May 2012 (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 effects of ghrelin is investigated by microdialysis technique. Subjects are healthy young men. End points are interstitial concentrations of glucose, lactate, and glycerol.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ghrelin | Active comparator | Drug: Acyl ghrelinGhrelin |
| Placebo | Placebo comparator | Drug: Placebo (Ringer acetate)Ringer acetate is used for placebo. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- healthy male
- age 18-65 years (included)
- Body mass index 20-25 (included)
Key exclusion criteria (5 listed)
- alcohol abuse
- malignant disease
- use of any medicine except otc painkillers
- any disease recognized
- participation in a trial using radioactive isotopes within the last 6 months
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 |
|---|---|---|
| Acyl ghrelinAlso: Human acyl ghrelin, GhrelinAcyl ghrelin 12.5 pg/min infused continuously for 300 minutes | Drug | Ghrelin |
| Placebo (Ringer acetate)Ringer acetate 2 microliter/min for 300 minutes | Drug | Placebo |
Primary outcome
Interstitial concentrations of glycerol
Time frame: Interstitial concentrations of glycerol at t=120 minutes
2 secondary outcomes
Interstitial concentrations of lactate
Time frame: Interstitial concentrations of lactate at t=120 minutes
Interstitial concentrations of glucose
Time frame: Interstitial concentrations of glucose at t=120 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 16 Jan 2013.
- Derived from this study: PubMed 23592479Vestergaard ET, Moller N, Jorgensen JO. Acute peripheral tissue effects of ghrelin on interstitial levels of glucose, glycerol, and lactate: a microdialysis study in healthy human subjects. Am J Physiol Endocrinol Metab. 2013 Jun 15;304(12):E1273-80. doi: 10.1152/ajpendo.00662.2012. Epub 2013 Apr 16.
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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.
Esben T. Vestergaard, MD PhD principal investigator
University of Aarhus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Acyl ghrelin in people with Healthy, run by Esben Thyssen Vestergaard 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 16 Jan 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 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. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
Interstitial concentrations of glycerol (time frame: Interstitial concentrations of glycerol at t=120 minutes). 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 NCT01595373, 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 16 Jan 2013.