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| Name | Class |
|---|---|
| Nationwide Children's Hospital | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Growth Hormone | Experimental | Growth hormone treatment 0.3 mg/kg/min |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| growth hormone | Drug | Growth Hormone treatment |
|
| Measure | Description | Time Frame |
|---|---|---|
| Reactive Hyperemic Response After 3 Months of Growth Hormone | Forearm blood flow (FBF) was measured using strain gauge venous occlusion plethysmography using a Hokanson EC6 plethysmograph (DE Hokanson Inc, Bellevue, WA) in the left arm. With this technique sphygmomanometric cuffs were placed on the arm at the wrist and on the upper arm. During measurement the wrist cuff was inflated to 200 mmHg to occlude flow to the hand which is primarily skin blood flow and the upper arm cuff is inflated to 40 mmHG for 10 out of every 15 second to occlude venous return. FBF was obtained by measuring arm expansion with an indium-in-silastic strain gauge. Data was recorded using PowerLab and Chart 4.0 (AD Instruments, Grand Junction, CO) on a Power Mac G4 computer (Apple, Cupertino, CA).For each subject two minutes of baseline FBF were recorded and then the upper arm cuff was inflated to 200 mmHg pressure for five minutes to occlude flow to the arm. It was then released and forearm blood flow was measured for the next minute. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Glucose | Plasma glucose | 3 months |
| Insulin | Plasma insulin | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert P Hoffman, MD | Ohio State University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ohio State University | Columbus | Ohio | 43210 | United States |
Clinical Trials.gov
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| ID | Title | Description |
|---|---|---|
| FG000 | Growth Hormone Treatment | Growth hormone 0.3 mg/kg/week given 6 days per week |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Growth Hormone Treatment |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Reactive Hyperemic Response After 3 Months of Growth Hormone | Forearm blood flow (FBF) was measured using strain gauge venous occlusion plethysmography using a Hokanson EC6 plethysmograph (DE Hokanson Inc, Bellevue, WA) in the left arm. With this technique sphygmomanometric cuffs were placed on the arm at the wrist and on the upper arm. During measurement the wrist cuff was inflated to 200 mmHg to occlude flow to the hand which is primarily skin blood flow and the upper arm cuff is inflated to 40 mmHG for 10 out of every 15 second to occlude venous return. FBF was obtained by measuring arm expansion with an indium-in-silastic strain gauge. Data was recorded using PowerLab and Chart 4.0 (AD Instruments, Grand Junction, CO) on a Power Mac G4 computer (Apple, Cupertino, CA).For each subject two minutes of baseline FBF were recorded and then the upper arm cuff was inflated to 200 mmHg pressure for five minutes to occlude flow to the arm. It was then released and forearm blood flow was measured for the next minute. | Posted | Mean | Standard Error | ml/dl min | 3 months |
|
Immediate
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Growth Hormone Treatment | 9 subjects will have either isolated GH deficiency (peak GH level less than 10 ng/ml in response to arginine-insulin stimulation with normal cortisol response and thyroid function tests) or growth hormone deficiency with other treated pituitary deficiencies. |
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Small sample size
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Robert P. Hoffman MD | Research Institute at Nationwide Children's hospital | 614-722-4425 | robert.hoffman@nationwidechildrens.org |
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| ID | Term |
|---|---|
| D004393 | Dwarfism, Pituitary |
| C580003 | Combined Pituitary Hormone Deficiency |
| D004392 | Dwarfism |
| ID | Term |
|---|---|
| D001848 | Bone Diseases, Developmental |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D001849 | Bone Diseases, Endocrine |
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| ID | Term |
|---|---|
| D013006 | Growth Hormone |
| ID | Term |
|---|---|
| D010908 | Pituitary Hormones, Anterior |
| D010907 | Pituitary Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
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| HOMA |
Insulin resistance |
| 3 months |
| Triglycerides | Plasma Triglycerides | 3 months |
| LDL | LDL level | 3 months |
| HDL | Plasma HDL | 3 months |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Post occlusion forearm blood flow | Mean | Standard Deviation | ml/dl*min |
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| Glucose | Mean | Standard Deviation | mg/dl |
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| insulin | Mean | Standard Deviation | uU/ml |
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| Homa | Mean | Standard Deviation | mg*uU/dl*ml |
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| triglycerides | Mean | Standard Deviation | mg/dl |
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| ldl | Mean | Standard Deviation | mg/dl |
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| HDL | Mean | Standard Deviation | mg/dl |
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| SBP | Mean | Standard Deviation | mmHg |
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| DBP | Mean | Standard Deviation | mmHg |
|
| Growth Hormone Treatment |
9 subject (8 male 1 female). 8 with isolated GH deficiency (peak GH level less than 10 ng/ml in response to arginine-insulin stimulation with normal cortisol response and thyroid function tests) 1 with panhypopitutarism on cortisol and thyroxine replacement |
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| Secondary | Glucose | Plasma glucose | Posted | Mean | Standard Deviation | mg/dl | 3 months |
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| Secondary | Insulin | Plasma insulin | Posted | Mean | Standard Error | uU/ml | 3 months |
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| Secondary | HOMA | Insulin resistance | Posted | Mean | Standard Error | mg uU/dl ml | 3 months |
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| Secondary | Triglycerides | Plasma Triglycerides | Posted | Mean | Standard Error | mg/dl | 3 months |
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| Secondary | LDL | LDL level | Posted | Mean | Standard Error | mg/dl | 3 months |
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| Secondary | HDL | Plasma HDL | Posted | Mean | Standard Error | mg/dl | 3 months |
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| 0 |
| 9 |
| 0 |
| 9 |
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| D007018 | Hypopituitarism |
| D010900 | Pituitary Diseases |
| D007027 | Hypothalamic Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D004700 | Endocrine System Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006730 |
| Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |