Cardiovascular DiseasePhase 1NCT00470002
Effects of Growth Hormone on the Nitric Oxide Pathway
A Phase 1 study testing Somatropin in people with Cardiovascular Disease, run by Hannover Medical School at 1 site in Germany.
Trial summary
The purpose of the study is to determine whether the treatment with growth hormone has an influence on the nitric oxide pathway in healthy males. Read more about this study
- Who is it for?
- Ages 50 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Disease
- What is being tested?
- Somatropin
- How many people
- 16 participants
- Where
- 1 siteGermany
- Study dates
- May 2004to Jan 2005
- Phase
- 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 50 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy male subjects without recent severe diseases
- Age 50 yrs or older
- Body mass index at or below 30 kg/m2
- Insulin-like growth factor-1 level below 200 ng/ml
- Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the trial
- Subjects that are willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures
Who cannot join
- History of any severe hepatic, renal, cardiac, endocrine, metabolic, or malignant diseases
- Requirement for medical drug treatment
- Growth hormone treatment during the last 12 months
- Drug dependence, alcohol or nicotine abuse
- Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or may interfere with the interpretation of study results and, in the judgement of the investigator, would make the subject inappropriate for entry into this study.
Trial locations and contacts
1 site in 1 country.
Germany1 site
Institute of Clinical Pharmacology, Hannover Medical School
Hanover, Lower Saxony, 30623
About this study
Official title: Effects of Growth Hormone (GH) on Parameters of the Nitric Oxide (NO) Pathway
The purpose of the study is to determine whether the treatment with growth hormone has an influence on the nitric oxide pathway in healthy males.
Read the detailed description
Nitric oxide (NO) is a potent endogenous vasodilator and has shown to inhibit key processes of atherosclerosis like monocyte adhesion, platelet aggregation, and vascular smooth muscle cell proliferation. Impaired endothelial NO production is a main feature of endothelial dysfunction, which by itself is an early step in the course of atherosclerotic vascular disease.
Recent studies could confirm this close association between parameters of the NO pathway and cardiovascular disease and could further enhance the knowledge on the pathophysiological mechanisms. There is a significant relationship between insulin resistance and the endogenous NO synthase inhibitor asymmetric dimethylarginine (ADMA). Moreover, evidence could be provided that plasma levels of ADMA are a strong and independent predictor of mortality and cardiovascular outcome in haemodialysis patients.
Patients with growth hormone deficiency are characterized by a 1.9 fold higher risk of death from cardiovascular disease. Again, there is good evidence, that alterations of the NO-pathway are involved in this increase of cardiovascular risk. A reduced endogenous systemic production of NO was found in patients with growth hormone deficiency, treatment with recombinant growth hormone normalized NO production. The effects of growth hormone on NO are possibly mediated by insulin-like growth factor-I (IGF-I), which stimulates NO synthesis in vitro. The onset of IGF-I increase in healthy volunteers treated with GH is evident after 12 h, the maximum effect takes place between 5 to 8 days. Also in adults with growth hormone deficiency, the major effects of growth hormone treatment on IGF-I levels are observed within 2 weeks. After discontinuation of growth hormone therapy, IGF-1 levels return to base line within 2-3 days.
The aim of the present study is to further elucidate the in vivo effects of GH on the NO pathway and NO mediated cardiovascular functions.
- Conditions
- Cardiovascular Disease
- Being tested
- Somatropin
- Keywords
- growth hormone, nitric oxide, nitrate, cyclic guanosine monophosphate, insulin-like growth factor-1, asymmetric dimethylarginine, blood pressure, endothelial progenitor cells
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SomatropinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary nitrate excretion
Measured: 10 days
Secondary outcomes (1)
Insulin-like growth factor-1 in serum
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2007 (estimated)
- Study startMay 2004
- Study completionJan 2005
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 Cardiovascular DiseaseStudies 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
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hannover Medical School
- Sponsor type
- University, hospital or other
- Collaborators
- Pharmacia
- Investigators
- Dirk O Stichtenoth, MD, Study director, Institute of Clinical Pharmacology, Hannover Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00470002
- Sponsor's protocol ID
- MES 03069
- Other IDs
- VP2-3900-4021576, IRB#3444
- Status last verified
- May 2007
- First submitted
- 4 May 2007
- Last updated
- 7 May 2007
- Results posted
- No
- Data monitoring committee
- No
Publications
Boger RH, Skamira C, Bode-Boger SM, Brabant G, von zur Muhlen A, Frolich JC. Nitric oxide may mediate the hemodynamic effects of recombinant growth hormone in patients with acquired growth hormone deficiency. A double-blind, placebo-controlled study. J Clin Invest. 1996 Dec 15;98(12):2706-13. doi: 10.1172/JCI119095.
PubMed 8981915Tsukahara H, Gordienko DV, Tonshoff B, Gelato MC, Goligorsky MS. Direct demonstration of insulin-like growth factor-I-induced nitric oxide production by endothelial cells. Kidney Int. 1994 Feb;45(2):598-604. doi: 10.1038/ki.1994.78.
PubMed 7513035
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Growth Hormone (GH) on Parameters of the Nitric Oxide (NO) Pathway
- ClinicalTrials.gov ID
- NCT00470002
- Acronym / sponsor ID
- MES 03069
- Conditions
- Cardiovascular Disease
- Keywords
- growth hormone, nitric oxide, nitrate, cyclic guanosine monophosphate, insulin-like growth factor-1, asymmetric dimethylarginine, blood pressure, endothelial progenitor cells
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Hannover Medical SchoolUniversity, hospital or other
- Collaborators
- Pharmacia
- Study start
- May 2004
- Study completion
- Jan 2005 (actual)
- First posted
- 7 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 the study is to determine whether the treatment with growth hormone has an influence on the nitric oxide pathway in healthy males.
Detailed description
Nitric oxide (NO) is a potent endogenous vasodilator and has shown to inhibit key processes of atherosclerosis like monocyte adhesion, platelet aggregation, and vascular smooth muscle cell proliferation. Impaired endothelial NO production is a main feature of endothelial dysfunction, which by itself is an early step in the course of atherosclerotic vascular disease.
Recent studies could confirm this close association between parameters of the NO pathway and cardiovascular disease and could further enhance the knowledge on the pathophysiological mechanisms. There is a significant relationship between insulin resistance and the endogenous NO synthase inhibitor asymmetric dimethylarginine (ADMA). Moreover, evidence could be provided that plasma levels of ADMA are a strong and independent predictor of mortality and cardiovascular outcome in haemodialysis patients.
Patients with growth hormone deficiency are characterized by a 1.9 fold higher risk of death from cardiovascular disease. Again, there is good evidence, that alterations of the NO-pathway are involved in this increase of cardiovascular risk. A reduced endogenous systemic production of NO was found in patients with growth hormone deficiency, treatment with recombinant growth hormone normalized NO production. The effects of growth hormone on NO are possibly mediated by insulin-like growth factor-I (IGF-I), which stimulates NO synthesis in vitro. The onset of IGF-I increase in healthy volunteers treated with GH is evident after 12 h, the maximum effect takes place between 5 to 8 days. Also in adults with growth hormone deficiency, the major effects of growth hormone treatment on IGF-I levels are observed within 2 weeks. After discontinuation of growth hormone therapy, IGF-1 levels return to base line within 2-3 days.
The aim of the present study is to further elucidate the in vivo effects of GH on the NO pathway and NO mediated cardiovascular functions.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 50 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Healthy male subjects without recent severe diseases
- Age 50 yrs or older
- Body mass index at or below 30 kg/m2
- Insulin-like growth factor-1 level below 200 ng/ml
- Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the trial
Key exclusion criteria (5 listed)
- History of any severe hepatic, renal, cardiac, endocrine, metabolic, or malignant diseases
- Requirement for medical drug treatment
- Growth hormone treatment during the last 12 months
- Drug dependence, alcohol or nicotine abuse
- Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or may interfere with the interpretation of study results and, in the judgement of the investigator, would make the subject inappropriate for entry into this study.
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 |
|---|---|---|
| Somatropin | Drug | – |
Primary outcome
Urinary nitrate excretion
Time frame: 10 days
1 secondary outcome
Insulin-like growth factor-1 in serum
Time frame: 10 days
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 7 May 2007.
- Background: PubMed 8981915Boger RH, Skamira C, Bode-Boger SM, Brabant G, von zur Muhlen A, Frolich JC. Nitric oxide may mediate the hemodynamic effects of recombinant growth hormone in patients with acquired growth hormone deficiency. A double-blind, placebo-controlled study. J Clin Invest. 1996 Dec 15;98(12):2706-13. doi: 10.1172/JCI119095.
- Background: PubMed 7513035Tsukahara H, Gordienko DV, Tonshoff B, Gelato MC, Goligorsky MS. Direct demonstration of insulin-like growth factor-I-induced nitric oxide production by endothelial cells. Kidney Int. 1994 Feb;45(2):598-604. doi: 10.1038/ki.1994.78.
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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.
Dirk O Stichtenoth, MD study director
Institute of Clinical Pharmacology, Hannover Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Somatropin in people with Cardiovascular Disease, run by Hannover Medical School at 1 site in Germany.
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 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 7 May 2007. 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 Germany. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Urinary nitrate excretion (time frame: 10 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 NCT00470002, 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 7 May 2007.