Growth Hormone's Effect on Endothelial Progenitor Cells

NCT00397592 | Completed

• 2 other identifiers: 0512121515
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Disease

Keywords

Growth Hormone; Cardiovascular System; Endothelial Progenitor Cells

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

Growth Hormone DRUG

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vanderbilt University: lead
• National Center for Research Resources (NCRR): collaborator

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

Growth Hormone

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Anterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Doug Vaughan, MD

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 8, 2006
• First Posted: November 9, 2006
• Study Start: August 1, 2006
• Study Completion: January 1, 2007
• Last Updated: July 3, 2007

Record last verified: 2007-07

Locations

US (1)