Growth Hormone DeficiencyNCT00646815
Insulin Sensitivity and Substrate Metabolism Before and After Treatment in Patients With Growth Hormone Deficiency
A study testing growth hormone (genotropin) in people with Growth Hormone Deficiency, run by University of Aarhus at 2 sites in Denmark.
Trial summary
The purpose of this study is to further characterize the treatment related changes in insulin sensitivity, substrate metabolism and intrahepatic-intramyocellular lipids in patients with growth hormone deficiency (GHD). Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Growth Hormone Deficiency
- What is being tested?
- growth hormone (genotropin)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 2 sitesDenmark
- Study dates
- Mar 2008to Sep 2009
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Written informed consent
- Must be of legal age and competent
- Age: >18 and <60 years old
- Presently diagnosed with growth hormone deficiency; if panhypopituitary, the patient must be sufficiently substituted in the other axis´s, for at least 3 months before inclusion in the study
- Written informed consent
- Must be of legal age and competent
Who cannot join
- Alcohol consumption >21 units per week
- Malignant disease
- Pregnancy
- Magnetic implants or material in the body
- Claustrophobia
- BMI >30
Show all 20Show fewer
- Heart disease (NYHA >2)
- Uncontrolled hypertension
- Manifest diabetes mellitus
- Change in medication, with any influence on glucose metabolism, 2 months prior to and until the end of the trial.
- Controls are matched on age, gender and BMI
- Alcohol consumption >21 units per week
- Malignant disease
- Pregnancy
- Magnetic implants or material in the body
- Claustrophobia
- Heart disease (NYHA >2)
- Uncontrolled hypertension
- Manifest diabetes mellitus
- Change in medication, with any influence on glucose metabolism, 2 months prior to and until the end of the trial
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Medical department M (Endocrinology and Diabetes), Aarhus University Hospital, Aarhus Sygehus, Denmark.
Aarhus, Aarhus, 8000
Medical Department M, Aarhus University Hospital
Aarhus, 8000
About this study
The purpose of this study is to further characterize the treatment related changes in insulin sensitivity, substrate metabolism and intrahepatic-intramyocellular lipids in patients with growth hormone deficiency (GHD).
- Conditions
- Growth Hormone Deficiency
- Being tested
- growth hormone (genotropin)
- Keywords
- insulin sensitivity, substrate metabolism, fatty liver, intramyocellular lipids, growth hormone deficiency, Growth hormone deficiency (Adult)
- Medical subject headings
- Dwarfism, Pituitary, Insulin Resistance, Fatty Liver
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
growth hormone (genotropin)Drug
Dosage regulation will follow the local recommendations of GHD treatment
| Study group | Role | What they receive |
|---|---|---|
| a | Experimental | the aim of the present study is to characterize the treatment related changes in insulin sensitivity, substrate metabolism and intrahepatic-intramyocellular lipids in 12 adult patients, recently diagnosed with growth hormone deficiency Receives: Drug: growth hormone (genotropin) |
| Control | No intervention | Intramyocellular, intrahepatic and intraabdominal lipid content, lean body mass and body fat percentage, are assessed in ten healthy controls matched on age, gender and BMI. |
What is being measured
The primary outcome is the main question the study is designed to answer.
insulin sensitivity
Measured: before and after 3 months treatment with growth hormone
Secondary outcomes (3)
substrate metabolism
Measured: before and after 3 months of growth hormone treatment
intrahepatic lipid content
Measured: before and after 3 months of growth hormone treatment
intramyocellular lipid content
Measured: before and after 3 months of growth hormone treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2008 (estimated)
- Study startMar 2008
- Primary completionSep 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Growth Hormone DeficiencyStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital
- Investigators
- Jens OL Jorgensen, Professor MD, Principal investigator, Medical Department M, Aarhus University Hospital, Aarhus, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00646815
- Sponsor's protocol ID
- LM2008
- Status last verified
- Oct 2009
- First submitted
- 19 Feb 2008
- Last updated
- 22 Oct 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Insulin Sensitivity and Substrate Metabolism Before and After Treatment in Patients With Growth Hormone Deficiency
- ClinicalTrials.gov ID
- NCT00646815
- Acronym / sponsor ID
- LM2008
- Conditions
- Growth Hormone Deficiency
- Keywords
- insulin sensitivity, substrate metabolism, fatty liver, intramyocellular lipids, growth hormone deficiency, Growth hormone deficiency (Adult)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Aarhus University Hospital
- Study start
- Mar 2008
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 31 Mar 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 purpose of this study is to further characterize the treatment related changes in insulin sensitivity, substrate metabolism and intrahepatic-intramyocellular lipids in patients with growth hormone deficiency (GHD).
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| a | Experimental | Drug: growth hormone (genotropin)the aim of the present study is to characterize the treatment related changes in insulin sensitivity, substrate metabolism and intrahepatic-intramyocellular lipids in 12 adult patients, recently diagnosed with growth hormone deficiency |
| Control | No intervention | –Intramyocellular, intrahepatic and intraabdominal lipid content, lean body mass and body fat percentage, are assessed in ten healthy controls matched on age, gender and BMI. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Written informed consent
- Must be of legal age and competent
- Age: >18 and <60 years old
- Presently diagnosed with growth hormone deficiency; if panhypopituitary, the patient must be sufficiently substituted in the other axis´s, for at least 3 months before inclusion in the study
- Written informed consent
Key exclusion criteria (20 listed)
- Alcohol consumption >21 units per week
- Malignant disease
- Pregnancy
- Magnetic implants or material in the body
- Claustrophobia
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 (genotropin)Dosage regulation will follow the local recommendations of GHD treatment | Drug | a |
Primary outcome
insulin sensitivity
Time frame: before and after 3 months treatment with growth hormone
3 secondary outcomes
substrate metabolism
Time frame: before and after 3 months of growth hormone treatment
intrahepatic lipid content
Time frame: before and after 3 months of growth hormone treatment
intramyocellular lipid content
Time frame: before and after 3 months of growth hormone treatment
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 22 Oct 2009.
- Danish Data Protection AgencyLink provided by the sponsor.
Related trials for Growth Hormone Deficiency
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Trial Investigating the Efficacy and Safety of Weekly Lonapegsomatropin Compared to Daily Somatropin in Children and Adolescents With Short Stature or Growth Failure Due to Growth Hormone Sufficient Disorders
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Randomized Clinical Trial of Two Different Initial Growth Hormone Doses in Children
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Phase 3 Study of LUM-201 in Children With Growth Hormone Deficiency
Growth Hormone Deficiency (GHD)
RecruitingPhase 3
Growth Hormone Replacement Therapy in Veterans With Mild Traumatic Brain Injury (mTBI) and Adult Growth Hormone Deficiency (AGHD)
Adult Growth Hormone Deficiency, Mild Traumatic Brain Injury
Enrolling by invitationObservational study
Influence of Adherence to Growth Hormone Therapy (GHT) With Norditropin® on Near Final Height in Patients With Growth Hormone Deficiency (GHD) and Born Small for Gestational Age (SGA)
Growth Hormone Deficiency in Children, Born Small for Gestational Age
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 OL Jorgensen, Professor MD principal investigator
Medical Department M, Aarhus University Hospital, Aarhus, Denmark
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing growth hormone (genotropin) in people with Growth Hormone Deficiency, run by University of Aarhus at 2 sites 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 6 inclusion and 20 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 22 Oct 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
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?
insulin sensitivity (time frame: before and after 3 months treatment with growth hormone). 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 22 Oct 2009.