Growth Hormone and Endothelial Function in Children

This study has been completed.
Sponsor:
Collaborator:
Nationwide Children's Hospital
Information provided by:
Ohio State University
ClinicalTrials.gov Identifier:
NCT00373386
First received: September 7, 2006
Last updated: June 27, 2008
Last verified: June 2008
  Purpose

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 Intervention Phase
Growth Hormone Deficiency
Panhypopituitarism
Short Stature
Drug: growth hormone
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Growth Hormone and Endothelial Function in Children

Resource links provided by NLM:


Further study details as provided by Ohio State University:

Primary Outcome Measures:
  • Change in Reactive Hyperemic response after 3 months of growth hormone [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Glucose, Insulin, lipid measurements [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Enrollment: 12
Study Start Date: January 2005
Study Completion Date: December 2007
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   8 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00373386

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

No publications provided

Responsible Party: Robert Hoffman, Research Institute at Nationwide Children's Hospital
ClinicalTrials.gov Identifier: NCT00373386     History of Changes
Other Study ID Numbers: Peds15
Study First Received: September 7, 2006
Last Updated: June 27, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Ohio State University:
growth hormone
endothelial function

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

ClinicalTrials.gov processed this record on October 29, 2014