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Growth Hormone and Endothelial Function in Children

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ClinicalTrials.gov Identifier: NCT00373386
Recruitment Status : Completed
First Posted : September 8, 2006
Last Update Posted : July 1, 2008
Nationwide Children's Hospital
Information provided by:
Ohio State University

Brief Summary:

Objective: This study is designed to determine whether growth hormone treatment in children 8 to 18 years of age alters function of the lining of the arteries. This may play a role in increasing or decreasing the risk of heart disease.

Methods. Twenty children, for whom growth hormone therapy will be otherwise provided, will be studied before and 3 months after starting growth hormone. Subjects can be on other hormonal replacements but no other medications.

Each study will be done in the fasting state. The blood vessel function will be determined by measuring the change in forearm blood flow before and after blocking flow to the arm for 5 minutes. Blood will be drawn after the test to measure glucose, insulin and fats.

Condition or disease Intervention/treatment Phase
Growth Hormone Deficiency Panhypopituitarism Short Stature Drug: growth hormone Phase 4

Detailed Description:

The purpose of the research is to learn more about how the lining of arteries in the body (called the endothelium) is affected by growth hormone treatment in children and adolescents. Poor function by the blood vessels is associated with increased risk of heart disease or stroke. This research is being done because growth hormone treatment has been shown to make the endothelium work better in adults. Growth hormone treatment may have the same or different effects in children because the dose is larger in children.

Children between 8 and 18 years who are to be started on growth hormone will be eligible to participate. Blood vessel function will be studied before starting growth hormone and 3 months after. This will be done by measuring blood flow to the arm before and after 5 min of stopping blood flow to the arm. The three months of growth hormone will be given free.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Growth Hormone and Endothelial Function in Children
Study Start Date : January 2005
Primary Completion Date : June 2007
Study Completion Date : December 2007

Primary Outcome Measures :
  1. Change in Reactive Hyperemic response after 3 months of growth hormone [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. Glucose, Insulin, lipid measurements [ Time Frame: 3 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • isolated growth hormone deficiency (peak growth hormone level less than 10 ng/ml in response to arginine-insulin stimulation with cortisol responses and thyroid function tests), panhypopituitarism with appropriate thyroxine (normal free T4 level) and cortisol replacement (8-12 mg/m2/day) and non classic growth hormone deficiency (growth velocity less than 5 cm/year; peak growth hormone >10 ng/ml).

Exclusion Criteria:

  • Taking medications other than the appropriate hormonal replacement(L-thyroxine, cortisol, estrogen or testosterone, DDAVP)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00373386

United States, Ohio
Ohio State University
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Ohio State University
Nationwide Children's Hospital
Study Chair: Robert P Hoffman, MD Ohio State University

Responsible Party: Robert Hoffman, Research Institute at Nationwide Children's Hospital
ClinicalTrials.gov Identifier: NCT00373386     History of Changes
Other Study ID Numbers: Peds15
First Posted: September 8, 2006    Key Record Dates
Last Update Posted: July 1, 2008
Last Verified: June 2008

Keywords provided by Ohio State University:
growth hormone
endothelial function

Additional relevant MeSH terms:
Dwarfism, Pituitary
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Bone Diseases, Endocrine
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases
Genetic Diseases, Inborn
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs