Growth Hormone DeficiencyNCT00491582
The Effects of Growth Hormone (GH) on Lipid Depots
A study testing Growth hormone replacement therapy in growth hormone deficient patients only. in people with Growth Hormone Deficiency, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial summary
This study aims at investigating the effect of growth hormone on lipid-content of muscle and liver as well as visceral fat mass in relation to insulin sensitivity. In addition, hormonal regulation and free fatty availability is assessed during a physical exercise at 50-60% VO2max. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Growth Hormone Deficiency
- What is being tested?
- Growth hormone replacement therapy in growth hormone deficient patients only.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jul 2007to Jun 2013
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male and female patients with proven GH-deficiency defined as a peak GH of less than 3mU/l during an insulin provocation test with nadir plasma glucose less than 2.2 mmol/l and additionally, stable conventional replacement therapy including corticoids, thyroxin and gonadal hormones as needed.
- Ability to perform an exercise test on a treadmill or a walking band.
- Willingness to participate in the study and to give written informed consent.
Who cannot join
- Active neoplasia
- Severe cardiovascular disease (unstable coronary heart disease, heart failure NYHA III-IV)
- Type 2 Diabetes mellitus
- Haemophilia or other coagulation disorder
- Inability to exercise
- Contraindications to exposure to a 3-T magnetic field (Pace-Makers, osteosynthetic material)
Show all 13Show fewer
- Pregnant women
- Women in childbearing age unless on a continuous contraceptive therapy or surgically sterilised.
- Abnormal liver or renal function (Creatinine >130mmol/L, normal reference 45-93mmol/L; ASAT and ALAT > 3 times the upper reference limit).
- Major depression, psychosis and other severe personality disorders
- Excessive alcohol consumption (>60g/d) or drug-abuse
- Refusal to give written consent
- Patients, who are not suitable for the study according to the study physician
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Abt. für Endokrinologie, Diabetologie und Klin. Ernährung, Inselspital
Bern, 3010
About this study
Official title: The Effect of Growth Hormone (GH) on Intramyocellular Lipids (IMCL), Intrahepatocellular Lipids (IHCL) and Visceral Fat Mass in Relation to Insulin Resistance
This study aims at investigating the effect of growth hormone on lipid-content of muscle and liver as well as visceral fat mass in relation to insulin sensitivity.
In addition, hormonal regulation and free fatty availability is assessed during a physical exercise at 50-60% VO2max.
Read more
Finally, the value of physical exercise in diagnosing growth hormone deficiency is investigated.
Hypothesis: 1) Lipid content of muscle and liver change with physical exercise and exercise capacity and free fatty availability will influence these changes. 2)Growth hormone replacement therapy will predominantly reduce visceral fat mass and increase free fatty availability.
3)Free fatty availability during exercise will be reduced in growth hormone deficient patients 4)Physical exercise may be an alternative way to diagnose growth hormone deficiency
Read the detailed description
Using the two-step hyperinsulinaemic-euglycaemic clamp technique hepatic and peripheral insulin sensitivity is assessed.
Lipid depots (skeletal muscle and liver) are measured by MR-spectroscopy, visceral fat mass by MR-imaging.
Exercise capacity ist measured on a treadmill. Counterregulatory hormones, glucose and free fatty acids are measured during a 2h physical exercise at 50-60 VO2max Identical investigations are performed in adult growth hormone (GH) deficient patients before and after six months GH replacement therapy, in sedentary matched control subjects and in endurance trained athletes.
- Conditions
- Growth Hormone Deficiency
- Being tested
- Growth hormone replacement therapy in growth hormone deficient patients only.
- Medical subject headings
- Dwarfism, Pituitary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Growth hormone replacement therapy in growth hormone deficient patients only.Drug
Also called Genotropin
Genotropin once/daily sc., titration scheme according to the consensus guidelines of the GH and IGF-research society Duration: 6 months
| Study group | Role | What they receive |
|---|---|---|
| Athletes, controls, patients | No intervention | Sedentary controls: age, BMI, Gender and waist matched (to the growth hormone deficient patients) healthy control subjects Endurance trained athletes: minimal >50 mlO2/KG body weight Receives: Drug: Growth hormone replacement therapy in growth hormone deficient patients only. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of visceral fat mass by MRI,Determination of IMCL and IHCL by MR Spectroscopy, Determination of peripheral and hepatic insulin sensitivity by two step hyperinsulinemic euglycemic clamp
Measured: 2008 - 2009
Secondary outcomes (2)
maximal exercise capacity
Measured: 2008 - 2009
Measurement of serum alphaKlothe by an ELISA
Measured in pg/mL
Measured: 2008 - 2013
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2007 (estimated)
- Study startJul 2007
- Primary completionJul 2009
- Study completionJun 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 Growth Hormone DeficiencyStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Collaborators
- Swiss National Science Foundation
- Responsible party
- Principal investigator, Emanuel Christ, Insel Gruppe AG, University Hospital Bern
- Investigators
- Emanuel R Christ, Prof,MD,PhD, Principal investigator, Abt. für Endokrinologie, Diabetologie und Klin. Ernährung, Inselspital, Berne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00491582
- Sponsor's protocol ID
- 320000-109522/1
- Status last verified
- Aug 2013
- First submitted
- 25 Jun 2007
- Last updated
- 13 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Egger A, Kreis R, Allemann S, Stettler C, Diem P, Buehler T, Boesch C, Christ ER. The effect of aerobic exercise on intrahepatocellular and intramyocellular lipids in healthy subjects. PLoS One. 2013 Aug 14;8(8):e70865. doi: 10.1371/journal.pone.0070865. eCollection 2013.
PubMed 23967125
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Growth Hormone (GH) on Intramyocellular Lipids (IMCL), Intrahepatocellular Lipids (IHCL) and Visceral Fat Mass in Relation to Insulin Resistance
- ClinicalTrials.gov ID
- NCT00491582
- Acronym / sponsor ID
- 320000-109522/1
- Conditions
- Growth Hormone Deficiency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Collaborators
- Swiss National Science Foundation
- Study start
- Jul 2007
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 26 Jun 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.
This study aims at investigating the effect of growth hormone on lipid-content of muscle and liver as well as visceral fat mass in relation to insulin sensitivity.
In addition, hormonal regulation and free fatty availability is assessed during a physical exercise at 50-60% VO2max.
Finally, the value of physical exercise in diagnosing growth hormone deficiency is investigated.
Hypothesis: 1) Lipid content of muscle and liver change with physical exercise and exercise capacity and free fatty availability will influence these changes. 2)Growth hormone replacement therapy will predominantly reduce visceral fat mass and increase free fatty availability.
3)Free fatty availability during exercise will be reduced in growth hormone deficient patients 4)Physical exercise may be an alternative way to diagnose growth hormone deficiency
Detailed description
Using the two-step hyperinsulinaemic-euglycaemic clamp technique hepatic and peripheral insulin sensitivity is assessed.
Lipid depots (skeletal muscle and liver) are measured by MR-spectroscopy, visceral fat mass by MR-imaging.
Exercise capacity ist measured on a treadmill. Counterregulatory hormones, glucose and free fatty acids are measured during a 2h physical exercise at 50-60 VO2max Identical investigations are performed in adult growth hormone (GH) deficient patients before and after six months GH replacement therapy, in sedentary matched control subjects and in endurance trained athletes.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Athletes, controls, patients | No intervention | Drug: Growth hormone replacement therapy in growth hormone deficient patients only.Sedentary controls: age, BMI, Gender and waist matched (to the growth hormone deficient patients) healthy control subjects Endurance trained athletes: minimal >50 mlO2/KG body weight |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male and female patients with proven GH-deficiency defined as a peak GH of less than 3mU/l during an insulin provocation test with nadir plasma glucose less than 2.2 mmol/l and additionally, stable conventional replacement therapy including corticoids, thyroxin and gonadal hormones as needed.
- Ability to perform an exercise test on a treadmill or a walking band.
- Willingness to participate in the study and to give written informed consent.
Key exclusion criteria (13 listed)
- Active neoplasia
- Severe cardiovascular disease (unstable coronary heart disease, heart failure NYHA III-IV)
- Type 2 Diabetes mellitus
- Haemophilia or other coagulation disorder
- Inability to exercise
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 |
|---|---|---|
| Growth hormone replacement therapy in growth hormone deficient patients only.Also: GenotropinGenotropin once/daily sc., titration scheme according to the consensus guidelines of the GH and IGF-research society Duration: 6 months | Drug | Athletes, controls, patients |
Primary outcome
Determination of visceral fat mass by MRI,Determination of IMCL and IHCL by MR Spectroscopy, Determination of peripheral and hepatic insulin sensitivity by two step hyperinsulinemic euglycemic clamp
Time frame: 2008 - 2009
2 secondary outcomes
maximal exercise capacity
Time frame: 2008 - 2009
Measurement of serum alphaKlothe by an ELISA
Time frame: 2008 - 2013
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 Aug 2013.
- Derived from this study: PubMed 23967125Egger A, Kreis R, Allemann S, Stettler C, Diem P, Buehler T, Boesch C, Christ ER. The effect of aerobic exercise on intrahepatocellular and intramyocellular lipids in healthy subjects. PLoS One. 2013 Aug 14;8(8):e70865. doi: 10.1371/journal.pone.0070865. eCollection 2013.
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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.
Emanuel R Christ, Prof,MD,PhD principal investigator
Abt. für Endokrinologie, Diabetologie und Klin. Ernährung, Inselspital, Berne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Growth hormone replacement therapy in growth hormone deficient patients only. in people with Growth Hormone Deficiency, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
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 13 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 Aug 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 Switzerland. 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?
Determination of visceral fat mass by MRI,Determination of IMCL and IHCL by MR Spectroscopy, Determination of peripheral and hepatic insulin sensitivity by two step hyperinsulinemic euglycemic clamp (time frame: 2008 - 2009). 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 NCT00491582, 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 13 Aug 2013.