Growth Hormone's Effect on Endothelial Progenitor Cells - Full Text View

Sponsors and Collaborators:	Vanderbilt University National Center for Research Resources (NCRR)
Information provided by:	Vanderbilt University
ClinicalTrials.gov Identifier:	NCT00397592

Purpose

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.

Condition	Intervention
Cardiovascular Disease	Drug: Growth Hormone

Drug Information available for: Somatropin Somatotropin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Non-Randomized, Open Label, Uncontrolled, Single Group Assignment
Official Title:	The Effect of Exogenous Growth Hormone on the Mobilization of Endothelial Progenitor Cells

Further study details as provided by Vanderbilt University:

Primary Outcome Measures:

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 Outcome Measures:

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

Enrollment:	18
Study Start Date:	August 2006
Study Completion Date:	January 2007

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.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00397592

Locations

United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232

Sponsors and Collaborators

Vanderbilt University

National Center for Research Resources (NCRR)

Investigators

Principal Investigator:

Doug Vaughan, MD

Vanderbilt University

More Information

No publications provided

Study ID Numbers:	051212, 1515
Study First Received:	November 8, 2006
Last Updated:	July 2, 2007
ClinicalTrials.gov Identifier:	NCT00397592 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Vanderbilt University:

Growth Hormone
Cardiovascular System
Endothelial Progenitor Cells

Study placed in the following topic categories:

Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Hormones

Additional relevant MeSH terms:

Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Cardiovascular Diseases
Hormones
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 07, 2009