HealthyNCT01209429
Importance of the GH/IGF-1 Axis for Human Substrate and Energy Metabolism During Calorie Restriction
A study testing GH hormone infusion, 42 hour fast and 12 hour fast in people with Healthy, run by University of Aarhus at 1 site in Denmark.
Trial summary
This study will investigate whether growth hormone is modulated by the enzyme SIRT1 and by that is stimulating lipolysis on expense of IGF-I production. This is done in 10 healthy men on calorie restriction on 4 study days with fat and skeletal muscle biopsies. Read more about this study
- Who is it for?
- Ages 18 to 70 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- GH hormone infusion, 42 hour fast and 12 hour fast
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteDenmark
- Study dates
- Sep 2010to Sep 2011
- 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 70 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- healthy lean men
- age >18
Who cannot join
- metabolic disturbances
- alcohol drug abuse
- malign disease: current or previous
Trial locations and contacts
1 site in 1 country.
About this study
This study will investigate whether growth hormone is modulated by the enzyme SIRT1 and by that is stimulating lipolysis on expense of IGF-I production. This is done in 10 healthy men on calorie restriction on 4 study days with fat and skeletal muscle biopsies.
Read the detailed description
It has been shown that calorie restriction enhances the length of life in yeast, worms, fish and rodent. Whether this elongation of life due to calorie restriction can be applied to humans is not known. However, it is a fact that calorie restriction will decrease the risk of developing metabolic disturbances such as diabetes, hypertension and atherosclerosis.
On the molecular level the specific relations are not fully understood. This study will investigate the possible connection between SITR1 and the relation to the GH/IGF-I axis and STAT5b in healthy men. The participant will fast 42 and 12 hours respectively, and have GH or placebo infusions. The design is a classical 2x2 design and will be randomized.
Knowledge of the interactions between calorie restriction, SIRT1, STAT5b and the GH/IGF-I axis will apply important information about the relations between aging, energy metabolism and metabolic disturbances.
- Conditions
- Healthy
- Being tested
- GH hormone infusion, 42 hour fast, 12 hour fast
- Keywords
- Calorie restriction, GH/IGF-I axis, STATb5, SIRT1, Intracellular signaling peptides and proteins, Fasting, Growth hormone, IGF-1
- Medical subject headings
- Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GH hormone infusionDrug
Also called Norditropin, Genotropin
Norditropin 30 ng/kg/min
42 hour fastBehavioural
Also called No other name
The participant will be fasting 42 hours prior to the start of the study day, drinking water is allowed
12 hour fastBehavioural
Also called No other name
12 hour fast will be used as a control scenario to 42 hour fast
| Study group | Role | What they receive |
|---|---|---|
| 42 hour fast/GH infusion | Experimental | Not described Receives: Drug: GH hormone infusion; Behavioral: 42 hour fast |
| 42 hour fast/Placebo infusion | Experimental | Not described Receives: Behavioral: 42 hour fast |
| 12 hour fast/GH infusion | Experimental | Not described Receives: Drug: GH hormone infusion; Behavioral: 12 hour fast |
| 12 hour fast/Placebo infusion | Placebo comparator | Not described Receives: Behavioral: 12 hour fast |
What is being measured
The primary outcome is the main question the study is designed to answer.
Description of intracellular pathways to clarify the interplay between calorie restriction, SIRT1, STATb5, and the GH/IGF-I axis
All study days consists of 3 hour basic periods and 3 hours hyperinsulinemic, euglycemic clamp.
Measured: 6 hour study days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2010 (estimated)
- Study startSep 2010
- Primary completionSep 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies 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
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Birgitte Nellemann, University of Aarhus
- Investigators
- Jens Otto L Jørgensen, Professor, Principal investigator, University Hospital of Aarhus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01209429
- Sponsor's protocol ID
- M-20100150
- Status last verified
- Sep 2011
- First submitted
- 24 Sep 2010
- Last updated
- 13 Sep 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Hjelholt AJ, Lee KY, Arlien-Soborg MC, Pedersen SB, Kopchick JJ, Puri V, Jessen N, Jorgensen JOL. Temporal patterns of lipolytic regulators in adipose tissue after acute growth hormone exposure in human subjects: A randomized controlled crossover trial. Mol Metab. 2019 Nov;29:65-75. doi: 10.1016/j.molmet.2019.08.013. Epub 2019 Aug 20.
PubMed 31668393Nellemann B, Vendelbo MH, Nielsen TS, Bak AM, Hogild M, Pedersen SB, Bienso RS, Pilegaard H, Moller N, Jessen N, Jorgensen JO. Growth hormone-induced insulin resistance in human subjects involves reduced pyruvate dehydrogenase activity. Acta Physiol (Oxf). 2014 Feb;210(2):392-402. doi: 10.1111/apha.12183. Epub 2013 Nov 22.
PubMed 24148194
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Importance of the GH/IGF-1 Axis for Human Substrate and Energy Metabolism During Calorie Restriction
- ClinicalTrials.gov ID
- NCT01209429
- Acronym / sponsor ID
- M-20100150
- Conditions
- Healthy
- Keywords
- Calorie restriction, GH/IGF-I axis, STATb5, SIRT1, Intracellular signaling peptides and proteins, Fasting, Growth hormone, IGF-1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 27 Sep 2010 (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.
This study will investigate whether growth hormone is modulated by the enzyme SIRT1 and by that is stimulating lipolysis on expense of IGF-I production. This is done in 10 healthy men on calorie restriction on 4 study days with fat and skeletal muscle biopsies.
Detailed description
It has been shown that calorie restriction enhances the length of life in yeast, worms, fish and rodent. Whether this elongation of life due to calorie restriction can be applied to humans is not known. However, it is a fact that calorie restriction will decrease the risk of developing metabolic disturbances such as diabetes, hypertension and atherosclerosis.
On the molecular level the specific relations are not fully understood. This study will investigate the possible connection between SITR1 and the relation to the GH/IGF-I axis and STAT5b in healthy men. The participant will fast 42 and 12 hours respectively, and have GH or placebo infusions. The design is a classical 2x2 design and will be randomized.
Knowledge of the interactions between calorie restriction, SIRT1, STAT5b and the GH/IGF-I axis will apply important information about the relations between aging, energy metabolism and metabolic disturbances.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 42 hour fast/GH infusion | Experimental | Drug: GH hormone infusion, Behavioral: 42 hour fast |
| 42 hour fast/Placebo infusion | Experimental | Behavioral: 42 hour fast |
| 12 hour fast/GH infusion | Experimental | Drug: GH hormone infusion, Behavioral: 12 hour fast |
| 12 hour fast/Placebo infusion | Placebo comparator | Behavioral: 12 hour fast |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- healthy lean men
- age >18
Key exclusion criteria (3 listed)
- metabolic disturbances
- alcohol drug abuse
- malign disease: current or previous
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 |
|---|---|---|
| GH hormone infusionAlso: Norditropin, GenotropinNorditropin 30 ng/kg/min | Drug | 12 hour fast/GH infusion, 42 hour fast/GH infusion |
| 42 hour fastAlso: No other nameThe participant will be fasting 42 hours prior to the start of the study day, drinking water is allowed | Behavioural | 42 hour fast/GH infusion, 42 hour fast/Placebo infusion |
| 12 hour fastAlso: No other name12 hour fast will be used as a control scenario to 42 hour fast | Behavioural | 12 hour fast/GH infusion, 12 hour fast/Placebo infusion |
Primary outcome
Description of intracellular pathways to clarify the interplay between calorie restriction, SIRT1, STATb5, and the GH/IGF-I axis
Time frame: 6 hour study days
All study days consists of 3 hour basic periods and 3 hours hyperinsulinemic, euglycemic clamp.
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 13 Sep 2011.
- Derived from this study: PubMed 31668393Hjelholt AJ, Lee KY, Arlien-Soborg MC, Pedersen SB, Kopchick JJ, Puri V, Jessen N, Jorgensen JOL. Temporal patterns of lipolytic regulators in adipose tissue after acute growth hormone exposure in human subjects: A randomized controlled crossover trial. Mol Metab. 2019 Nov;29:65-75. doi: 10.1016/j.molmet.2019.08.013. Epub 2019 Aug 20.
- Derived from this study: PubMed 24148194Nellemann B, Vendelbo MH, Nielsen TS, Bak AM, Hogild M, Pedersen SB, Bienso RS, Pilegaard H, Moller N, Jessen N, Jorgensen JO. Growth hormone-induced insulin resistance in human subjects involves reduced pyruvate dehydrogenase activity. Acta Physiol (Oxf). 2014 Feb;210(2):392-402. doi: 10.1111/apha.12183. Epub 2013 Nov 22.
Related trials for Healthy
RecruitingObservational study
Studies of Blood Flow to the Brain During Thought
Healthy Volunteer
Enrolling by invitationObservational study
Screening for Hematology Branch Protocols
Hematologic Disease and Disorders, Donors
Enrolling by invitationObservational study
Collection of Tissue Specimens From Patients With Solid Tumors or Blood Disorders and Their HLA-Compatible Family Members
Neoplasms, Hematologic Neoplasms
Enrolling by invitationObservational study
Collection and Distribution of Samples From Healthy Donors for In Vitro Research at the NCI-Frederick
Healthy Donors
RecruitingObservational study
Collection and Analysis of Blood, Bone Marrow, and Buccal Mucosa Samples From Healthy Volunteers
Healthy Volunteers
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, Professor principal investigator
University Hospital of Aarhus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GH hormone infusion, 42 hour fast and 12 hour fast in people with Healthy, 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 2 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 13 Sep 2011. 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?
Description of intracellular pathways to clarify the interplay between calorie restriction, SIRT1, STATb5, and the GH/IGF-I axis (time frame: 6 hour study days). 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 NCT01209429, which also lists 2 linked publications.
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 13 Sep 2011; AzTrials last refreshed its copy on 6 Nov 2026.