Growth Hormone DeficiencyNCT00397319
Growth Hormone's Effect on the Cardiovascular System
An observational study of Growth Hormone Deficiency, run by Vanderbilt University at 1 site in United States.
Trial summary
To evaluate specific markers of cardiovascular risk before and after growth hormone replacement therapy in a population of growth hormone deficient adults, as compared to an age, gender, and BMI-matched healthy population. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Growth Hormone Deficiency
- What is being tested?
- Growth Hormone
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2005to Dec 2006
- Phase
- Observational
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult between the ages of 18 and 65
- Documented Growth Hormone Deficiency as defined by a peak Growth Hormone during a GHRH-Arginine Stimulation test not exceeding 9.5 ng/ml
Who cannot join
- Personal history of cardiovascular disease (previous myocardial infarction or known coronary artery disease) or diagnosis of heart disease between study visits.
- Personal history of diabetes mellitus or development of diabetes between study visits.
- Initiation of an anti-cholesterol medication or anti-hypertensive between baseline and follow-up study visit.
- Initiation of regular tobacco use between baseline and follow-up study visit.
- Pregnancy or nursing
- Current daily use of any drug known to affect the fibrinolytic system: Aspirin, Aggrenox, Plavix, Persantine, Ticlid, Pletal, Trental, Lovenox, Coumadin, Agrylin, and Hydroxyurea.
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
About this study
Official title: The Role of Growth Hormone in Cardiovascular Health
To evaluate specific markers of cardiovascular risk before and after growth hormone replacement therapy in a population of growth hormone deficient adults, as compared to an age, gender, and BMI-matched healthy population.
Read the detailed description
Growth hormone deficiency (GHD) is associated with increased cardiovascular morbidity and mortality. The effects of such a deficiency include decreased exercise capacity and tolerance, impaired cardiac function, a central fat redistribution, increased peripheral arterial resistance, and an unfavorable lipid profile. These effects have been found to be reversed with appropriate replacement therapy with recombinant human growth hormone. We plan to utilize several experimental systems to further investigate the role of growth hormone (GH) in maintaining cardiovascular health. In particular, we would like to further understand the interaction of GH with Plasminogen-activator-inhibitor-1 (a major activator of the fibrinolytic system) as well as the role of GH in the maintenance of vascular function.
- Conditions
- Growth Hormone Deficiency
- Being tested
- Growth Hormone
- Keywords
- Growth Hormone, Cardiovascular System
- 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 HormoneDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2006 (estimated)
- Study startAug 2005
- Study completionDec 2006
Why it stopped: Inadequate retention of GHD adults to maintain power to study the effect of GH on fibrinolysis. A comparison between GHD adults and controls was completed.
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.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 26 participants
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer, National Center for Research Resources (NCRR)
- Investigators
- Doug Vaughan, MD, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00397319
- Sponsor's protocol ID
- 050045
- Other IDs
- 1422
- Status last verified
- Jul 2007
- First submitted
- 8 Nov 2006
- Last updated
- 3 Jul 2007
- Results posted
- No
Publications
Devin JK, Blevins LS Jr, Verity DK, Chen Q, Bloodworth JR Jr, Covington J, Vaughan DE. Markedly impaired fibrinolytic balance contributes to cardiovascular risk in adults with growth hormone deficiency. J Clin Endocrinol Metab. 2007 Sep;92(9):3633-9. doi: 10.1210/jc.2007-0609. Epub 2007 Jun 19.
PubMed 17579195
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Growth Hormone in Cardiovascular Health
- ClinicalTrials.gov ID
- NCT00397319
- Acronym / sponsor ID
- 050045
- Conditions
- Growth Hormone Deficiency
- Keywords
- Growth Hormone, Cardiovascular System
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Inadequate retention of GHD adults to maintain power to study the effect of GH on fibrinolysis. A comparison between GHD adults and controls was completed.
- Enrolment
- 26 participants
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Collaborators
- Pfizer, National Center for Research Resources (NCRR)
- Study start
- Aug 2005
- Study completion
- Dec 2006 (actual)
- First posted
- 9 Nov 2006 (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.
To evaluate specific markers of cardiovascular risk before and after growth hormone replacement therapy in a population of growth hormone deficient adults, as compared to an age, gender, and BMI-matched healthy population.
Detailed description
Growth hormone deficiency (GHD) is associated with increased cardiovascular morbidity and mortality. The effects of such a deficiency include decreased exercise capacity and tolerance, impaired cardiac function, a central fat redistribution, increased peripheral arterial resistance, and an unfavorable lipid profile. These effects have been found to be reversed with appropriate replacement therapy with recombinant human growth hormone. We plan to utilize several experimental systems to further investigate the role of growth hormone (GH) in maintaining cardiovascular health. In particular, we would like to further understand the interaction of GH with Plasminogen-activator-inhibitor-1 (a major activator of the fibrinolytic system) as well as the role of GH in the maintenance of vascular function.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult between the ages of 18 and 65
- Documented Growth Hormone Deficiency as defined by a peak Growth Hormone during a GHRH-Arginine Stimulation test not exceeding 9.5 ng/ml
Key exclusion criteria (6 listed)
- Personal history of cardiovascular disease (previous myocardial infarction or known coronary artery disease) or diagnosis of heart disease between study visits.
- Personal history of diabetes mellitus or development of diabetes between study visits.
- Initiation of an anti-cholesterol medication or anti-hypertensive between baseline and follow-up study visit.
- Initiation of regular tobacco use between baseline and follow-up study visit.
- Pregnancy or nursing
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 | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early (reason given: Inadequate retention of GHD adults to maintain power to study the effect of GH on fibrinolysis. A comparison between GHD adults and controls was completed.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2007.
- Derived from this study: PubMed 17579195Devin JK, Blevins LS Jr, Verity DK, Chen Q, Bloodworth JR Jr, Covington J, Vaughan DE. Markedly impaired fibrinolytic balance contributes to cardiovascular risk in adults with growth hormone deficiency. J Clin Endocrinol Metab. 2007 Sep;92(9):3633-9. doi: 10.1210/jc.2007-0609. Epub 2007 Jun 19.
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Growth Hormone Deficiency in Children, Born Small for Gestational Age
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Growth Hormone Deficiency Without Epiphyseal Closure
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.
Doug Vaughan, MD principal investigator
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Growth Hormone Deficiency, run by Vanderbilt University at 1 site in United States.
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 6 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: stopped early, as of the sponsor's last update on 3 Jul 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 United States. 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 was stopped early (reason given: Inadequate retention of GHD adults to maintain power to study the effect of GH on fibrinolysis. A comparison between GHD adults and controls was completed.). Results are not available in the source record.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00397319, 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 3 Jul 2007.