Growth Hormone's Effect on Endothelial Progenitor Cells

July 2, 2007 updated by: Vanderbilt University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

18

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

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.

Secondary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vanderbilt University

Collaborators

National Center for Research Resources (NCRR)

Investigators

  • Principal Investigator: Doug Vaughan, MD, Vanderbilt University Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2006

Study Completion (Actual)

January 1, 2007

Study Registration Dates

First Submitted

November 8, 2006

First Submitted That Met QC Criteria

November 8, 2006

First Posted (Estimate)

November 9, 2006

Study Record Updates

Last Update Posted (Estimate)

July 3, 2007

Last Update Submitted That Met QC Criteria

July 2, 2007

Last Verified

July 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 051212
  • 1515

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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