Status:
COMPLETED
Growth Hormone's Effect on Endothelial Progenitor Cells
Lead Sponsor:
Vanderbilt University
Collaborating Sponsors:
National Center for Research Resources (NCRR)
Conditions:
Cardiovascular Disease
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief 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.
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 in...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
- 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.
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2007
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00397592
Start Date
August 1 2006
End Date
January 1 2007
Last Update
July 3 2007
Active Locations (1)
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1
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232