Cardiovascular DiseaseNCT00397592
Growth Hormone's Effect on Endothelial Progenitor Cells
A study testing Growth Hormone in people with Cardiovascular Disease, run by Vanderbilt University at 1 site in United States.
Trial summary
To assess the effect of short-term low-dose growth hormone therapy on the mobilization of endothelial progenitor cells from the bone marrow within a group of healthy adults. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Disease
- What is being tested?
- Growth Hormone
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2006to Jan 2007
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults age 18 thru 65
- Serum IGF-1 in the lower half of the age and gender-specific normal range at the time of screening visit
Who cannot join
- Systemic hypertension, as defined as current BP >140/90 on screening visit, or taking anti-hypertensive therapy.
- Diabetes mellitus, as defined by known diagnosis or Fasting Blood Glucose >126 at the time of screening visit.
- Women who are pregnant or nursing, as confirmed by history or seum beta-hCG at the time of screening visit.
- Women who are taking exogenous oral estrogens of any kind.
- Personal history of active cancer or recurrence within the past 10 years, with the exception of non-melanoma skin cancer.
- Personal history of an untreated benign intracranial neoplasm.
Show all 10Show fewer
- Initiation of statin therapy during the course of the study.
- A serum IGF-1 level below the age and gender-specific normal range at the time of screening visit.
- Renal insufficiency, as defined by a GFR <60 mls/min/1.73 m2 upon Renal Function panel at the time of screening visit.
- Hepatic insufficiency, as defined by an AST and/or ALT >twice the upper limit of normal at the time of screening visit.
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 Effect of Exogenous Growth Hormone on the Mobilization of Endothelial Progenitor Cells
To assess the effect of short-term low-dose growth hormone therapy on the mobilization of endothelial progenitor cells from the bone marrow within a group of healthy adults.
Read the detailed description
We are proposing a pilot study to assess the effect of the administration of recombinant human growth hormone on the number of endothelial progenitor cells (EPC's) in the peripheral circulation. An increase in the number of EPC's is viewed as beneficial, as it has been postulated that they provide an endogenous repair mechanism to counteract endothelial injury. Additionally, a reduced number of EPC's has been found to independently predict atherosclerotic disease progression. Mechanisms proposed for enhancing the number of circulating EPC's and their function include an increase in proliferation, mobilization from the bone marrow, or prevention of EPC apoptosis. Thus, a pharmacologic manipulation of the number of EPC's in the peripheral circulation could potentially serve as a mechanism by which endothelial function, and thus vascular health, may be improved.
- Conditions
- Cardiovascular Disease
- Being tested
- Growth Hormone
- Keywords
- Growth Hormone, Cardiovascular System, 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.
Growth HormoneDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Endothelial Progenitor Cells per mm^2 in culture after a maximum of 8 weeks of growth hormone therapy or until somatomedin-C is in the upper quartile of the normal range, as compared to baseline.
Secondary outcomes (8)
All outcome measures will be assessed at baseline and following either a maximum of 8 weeks of growth hormone therapy or until somatomedin-C is in the upper quartile of the normal range:CD34/KDR+ Endothelial Progenitor Cells
Plasma nitrite and nitrate
L-Arginine
ADMA
estradiol
erythropoietin
SDF-1
VEGF
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 2006
- Study completionJan 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 N/A
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Research Resources (NCRR)
- Investigators
- Doug Vaughan, MD, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00397592
- Sponsor's protocol ID
- 051212
- Other IDs
- 1515
- Status last verified
- Jul 2007
- First submitted
- 8 Nov 2006
- Last updated
- 3 Jul 2007
- Results posted
- No
- Data monitoring committee
- No
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 Effect of Exogenous Growth Hormone on the Mobilization of Endothelial Progenitor Cells
- ClinicalTrials.gov ID
- NCT00397592
- Acronym / sponsor ID
- 051212
- Conditions
- Cardiovascular Disease
- Keywords
- Growth Hormone, Cardiovascular System, Endothelial Progenitor Cells
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Collaborators
- National Center for Research Resources (NCRR)
- Study start
- Aug 2006
- Study completion
- Jan 2007 (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 assess the effect of short-term low-dose growth hormone therapy on the mobilization of endothelial progenitor cells from the bone marrow within a group of healthy adults.
Detailed description
We are proposing a pilot study to assess the effect of the administration of recombinant human growth hormone on the number of endothelial progenitor cells (EPC's) in the peripheral circulation. An increase in the number of EPC's is viewed as beneficial, as it has been postulated that they provide an endogenous repair mechanism to counteract endothelial injury. Additionally, a reduced number of EPC's has been found to independently predict atherosclerotic disease progression. Mechanisms proposed for enhancing the number of circulating EPC's and their function include an increase in proliferation, mobilization from the bone marrow, or prevention of EPC apoptosis. Thus, a pharmacologic manipulation of the number of EPC's in the peripheral circulation could potentially serve as a mechanism by which endothelial function, and thus vascular health, may be improved.
Study design
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adults age 18 thru 65
- Serum IGF-1 in the lower half of the age and gender-specific normal range at the time of screening visit
Key exclusion criteria (10 listed)
- Systemic hypertension, as defined as current BP >140/90 on screening visit, or taking anti-hypertensive therapy.
- Diabetes mellitus, as defined by known diagnosis or Fasting Blood Glucose >126 at the time of screening visit.
- Women who are pregnant or nursing, as confirmed by history or seum beta-hCG at the time of screening visit.
- Women who are taking exogenous oral estrogens of any kind.
- Personal history of active cancer or recurrence within the past 10 years, with the exception of non-melanoma skin cancer.
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
Number of Endothelial Progenitor Cells per mm^2 in culture after a maximum of 8 weeks of growth hormone therapy or until somatomedin-C is in the upper quartile of the normal range, as compared to baseline.
8 secondary outcomes
All outcome measures will be assessed at baseline and following either a maximum of 8 weeks of growth hormone therapy or until somatomedin-C is in the upper quartile of the normal range:CD34/KDR+ Endothelial Progenitor Cells
Plasma nitrite and nitrate
L-Arginine
ADMA
estradiol
erythropoietin
SDF-1
VEGF
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 3 Jul 2007.
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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.
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?
A study testing Growth Hormone in people with Cardiovascular Disease, 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 10 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 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 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?
Number of Endothelial Progenitor Cells per mm^2 in culture after a maximum of 8 weeks of growth hormone therapy or until somatomedin-C is in the upper quartile of the normal range, as compared to baseline.. 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 3 Jul 2007.