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| Sponsor: | Ohio State University |
|---|---|
| Collaborator: |
Nationwide Children's Hospital |
| Information provided by: | Ohio State University |
| ClinicalTrials.gov Identifier: | NCT00373386 |
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 |
| 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) |
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Ohio | |
| Ohio State University | |
| Columbus, Ohio, United States, 43210 | |
| Study Chair: | Robert P Hoffman, MD | Ohio State University |
More Information
| 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 |
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growth hormone endothelial function |
|
Dwarfism Dwarfism, Pituitary Hypopituitarism Endocrine System Diseases Bone Diseases, Developmental Bone Diseases Musculoskeletal Diseases Genetic Diseases, Inborn Bone Diseases, Endocrine |
Pituitary Diseases Hypothalamic Diseases Brain Diseases Central Nervous System Diseases Nervous System Diseases Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions |
