Growth Hormone's Effect on Endothelial Progenitor Cells

Cardiovascular Disease Clinical Trial

Official title:

The Effect of Exogenous Growth Hormone on the Mobilization of Endothelial Progenitor Cells

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00397592
• Other study ID #: 051212
• Secondary ID: 1515
• Status: Completed
• Phase: N/A
• First received: November 8, 2006
• Last updated: July 2, 2007
• Start date: August 2006
• Est. completion date: January 2007

Study information

• Verified date: July 2007
• Source: Vanderbilt University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: January 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 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 Criteria:

• 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.

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases

Intervention

Drug:
• Growth Hormone

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Vanderbilt University	National Center for Research Resources (NCRR)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Plasma nitrite and nitrate
Secondary	L-Arginine
Secondary	ADMA
Secondary	estradiol
Secondary	erythropoietin
Secondary	SDF-1
Secondary	VEGF