Insulin ResistanceNCT00477997
Effect of Growth Hormone on Insulin Signaling in Muscle Tissue
A study testing Physiological Bolus of Growth Hormone in people with Insulin Resistance, run by University of Aarhus at 1 site in Denmark.
Trial summary
The purpose of this study is to examine the effects of a physiological bolus of growth hormone on insulin signaling pathways in muscle tissue in healthy lean men. Read more about this study
- Who is it for?
- Ages 18 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Insulin Resistance
- What is being tested?
- Physiological Bolus of Growth Hormone
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8 participants
- Where
- 1 siteDenmark
- Study dates
- May 2007to Aug 2008
- 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 30 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male
- Healthy
- Age between 18 and 30 years
- BMI ≤ 26
Who cannot join
- Known present disease including diabetes mellitus
- BMI > 26
- Uses any medication
- Consumes > 21 units of alcohol per week
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of a Physiological Bolus of Growth Hormone (GH) on Insulin Signaling Pathways in Muscle Tissue From Healthy Adults
The purpose of this study is to examine the effects of a physiological bolus of growth hormone on insulin signaling pathways in muscle tissue in healthy lean men.
- Conditions
- Insulin Resistance
- Being tested
- Physiological Bolus of Growth Hormone
- Keywords
- Growth Hormone, Insulin Signaling, GH signaling
- Medical subject headings
- Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physiological Bolus of Growth HormoneDevice
0,5 mg Norditropin
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | Saline bolus + OGTT Receives: Device: Physiological Bolus of Growth Hormone |
| 2 | Other | GH-bolus and OGTT Receives: Device: Physiological Bolus of Growth Hormone |
| 3 | Other | GH-bolus Receives: Device: Physiological Bolus of Growth Hormone |
What is being measured
The primary outcome is the main question the study is designed to answer.
PI3-kinase activity i muscle tissue
Measured: 2 hours
Secondary outcomes (1)
Growth Hormone Signaling Proteins in Muscle Tissue and other Insulin Signaling Proteins in Muscle Tissue
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2007 (estimated)
- Study startMay 2007
- Primary completionApr 2008
- Study completionAug 2008
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 Insulin ResistanceStudies 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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- 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
- Collaborators
- Aarhus University Hospital
- Investigators
- Jens Otto L Jørgensen, MD, DMSc, Principal investigator, Department M (endocrinology and diabetes), Aarhus University Hospital, Norrebrogade 44, 8000 Aarhus C, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00477997
- Sponsor's protocol ID
- MM-GH-20070052
- Status last verified
- Apr 2009
- First submitted
- 23 May 2007
- Last updated
- 21 Apr 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Krusenstjerna-Hafstrom T, Madsen M, Vendelbo MH, Pedersen SB, Christiansen JS, Moller N, Jessen N, Jorgensen JO. Insulin and GH signaling in human skeletal muscle in vivo following exogenous GH exposure: impact of an oral glucose load. PLoS One. 2011 May 3;6(5):e19392. doi: 10.1371/journal.pone.0019392.
PubMed 21559284
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Physiological Bolus of Growth Hormone (GH) on Insulin Signaling Pathways in Muscle Tissue From Healthy Adults
- ClinicalTrials.gov ID
- NCT00477997
- Acronym / sponsor ID
- MM-GH-20070052
- Conditions
- Insulin Resistance
- Keywords
- Growth Hormone, Insulin Signaling, GH signaling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Aarhus University Hospital
- Study start
- May 2007
- Primary completion
- Apr 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 24 May 2007 (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 purpose of this study is to examine the effects of a physiological bolus of growth hormone on insulin signaling pathways in muscle tissue in healthy lean men.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Device: Physiological Bolus of Growth HormoneSaline bolus + OGTT |
| 2 | Other | Device: Physiological Bolus of Growth HormoneGH-bolus and OGTT |
| 3 | Other | Device: Physiological Bolus of Growth HormoneGH-bolus |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Male
- Healthy
- Age between 18 and 30 years
- BMI ≤ 26
Key exclusion criteria (4 listed)
- Known present disease including diabetes mellitus
- BMI > 26
- Uses any medication
- Consumes > 21 units of alcohol per week
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 |
|---|---|---|
| Physiological Bolus of Growth Hormone0,5 mg Norditropin | Device | 1, 2, 3 |
Primary outcome
PI3-kinase activity i muscle tissue
Time frame: 2 hours
1 secondary outcome
Growth Hormone Signaling Proteins in Muscle Tissue and other Insulin Signaling Proteins in Muscle Tissue
Time frame: 2 hours
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 21 Apr 2009.
- Derived from this study: PubMed 21559284Krusenstjerna-Hafstrom T, Madsen M, Vendelbo MH, Pedersen SB, Christiansen JS, Moller N, Jessen N, Jorgensen JO. Insulin and GH signaling in human skeletal muscle in vivo following exogenous GH exposure: impact of an oral glucose load. PLoS One. 2011 May 3;6(5):e19392. doi: 10.1371/journal.pone.0019392.
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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 Jørgensen, MD, DMSc principal investigator
Department M (endocrinology and diabetes), Aarhus University Hospital, Norrebrogade 44, 8000 Aarhus C, 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 Physiological Bolus of Growth Hormone in people with Insulin Resistance, 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 4 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 21 Apr 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. 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.
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?
PI3-kinase activity i muscle tissue (time frame: 2 hours). 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 NCT00477997, 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 21 Apr 2009.