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This is a two arm, randomized, prospective, intervention study in order to determine the effects of growth hormone treatment on eating regulation and to compare between the growth responses with or without nutritional intervention in short stature children.
The study will include 30 short stature children that are about to initiate growth hormone treatment and will last for one year. After 4 months of treatment, children will be randomized into two groups:
At screening visit and during the study the following parameters will be evaluated: height, weight, growth markers in the blood and urine, child eating behavior questionnaire, blood tests, hormonal tests and resting energy expenditure measurements.
This is a two arm, randomized, prospective, intervention study in order to determine the effects of growth hormone treatment on eating regulation and to compare between the growth responses with or without nutritional intervention in short stature children.
Background:
In the last three decades children with different kinds of short stature pathologies were treated with growth hormone. Most of the attention in growth hormone studies is focused on the effect of the treatment on growth. Today there are very few studies that are focused on the effect of growth hormone on eating regulations and the connection between eating regulations and growth improvement in growth hormone treatment.
Objectives:
To evaluate the effect of short term growth hormone treatment on the following parameters:
To evaluate the effect of nutritional support on growth rate in one year growth hormone treatment.
To evaluate changes in growth markers in the serum and urine during growth hormone treatment.
Methods:
The study will include 30 short stature children that are about to initiate growth hormone treatment and will last for one year. After 4 months of treatment children will be randomized into two groups:
The nutritional intervention will include nutritional consultation and applying a personal dietetic menu. At screening visit and during the study the following parameters will be evaluated: height, weight, growth markers in the blood and urine, food diary, child eating behavior questionnaire, resting energy expenditure measurements, blood tests, hormonal tests and fasting and post-prandial levels of leptin, ghrelin, GLP-1, insulin and glucose.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Growth hormone and nutritional intervention |
|
| 2 | Active Comparator | growth hormone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| growth hormone- Genotropin or NorditropinSimplex and nutritional intervention | Behavioral | A combined treatment of growth hormone (Genotropin or NorditropinSimplex or "Biotropin") and nutritional intervention |
| Measure | Description | Time Frame |
|---|---|---|
| height and weight | every visit until the end of study | |
| Growth markers | At screening visit, baseline and at the end of the visit |
| Measure | Description | Time Frame |
|---|---|---|
| Safety laboratory parameters | at screening, baseline and at the end of the study | |
| food diary | every visit until the end of the study | |
| Resting energy expenditure measurements |
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Inclusion Criteria:
Height of at least 2.0 standard deviations below the mean height for chronological age and sex according to the 2000 standards from the Centers for Disease Control and Prevention (CDC).
Children that have one of the following short stature pathologies:
Proper function of thyroid gland, kidney and liver
Prior to initiating growth hormone treatment
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Moshe Phillip, Professor | Schneider Children Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Schneider Children's Medical Center | Petah Tikva | Israel |
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| ID | Term |
|---|---|
| D004392 | Dwarfism |
| ID | Term |
|---|---|
| D001848 | Bone Diseases, Developmental |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D030342 | Genetic Diseases, Inborn |
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| growth hormone-Genotropin or NorditropinSimplex or "Biotropin" | Behavioral | Growth hormone treatment (Genotropin, or NorditropinSimplex or "Biotropin"). |
|
| Every visit other than visit number 4 |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D004700 | Endocrine System Diseases |