Effects of Growth Hormone (GH) Treatment on Eating Regulation
Effects of Growth Hormone (GH) Treatment on Eating Regulation
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:

 1. Control group that will continue with growth hormone treatment without any other
 intervention.

 2. Study group that will be a given a nutritional intervention in addition to growth
 hormone treatment.

 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:

 1. To evaluate the effect of short term growth hormone treatment on the following
 parameters:

 1. Appetite, food preference, amount of food and ingredients.

 2. Changes in food regulations.

 3. Changes in body composition.

 4. Changes in resting energy expenditure.

 5. Changes in hormones that are associated with appetite and with energy balance:
 IGF-1,IGFBP1&3 and Ghrelin.

 6. Changes in metabolic and nutritional measurements: glucose, insulin, lipid profile,
 total proteins, albumin, liver functions, alkaline-phosphatase, hemoglobin,
 transferrin, iron, B12, folic acid.

 2. To evaluate the effect of nutritional support on growth rate in one year growth hormone
 treatment.

 3. 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:

 1. Control group that will continue with growth hormone treatment without any other
 intervention.

 2. Study group that will be given a nutritional intervention In addition to growth hormone
 treatment.

 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.
Inclusion Criteria:

 1. 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).

 2. Children that have one of the following short stature pathologies:

 1. IGHD or MPHD

 2. ISS

 3. SGA

 3. Proper function of thyroid gland, kidney and liver

 4. Prior to initiating growth hormone treatment

 Exclusion Criteria:

 1. Chronic diseases

 2. Diseases in the digestive system.

 3. Neurological diseases.

 4. Malignant diseases in the past or in the present. Treated with chemotherapy or
 radiation.

 5. Genetic syndromes

 6. Bone diseases

 7. Taking chronic medicine, SSRI type, that effect the appetite and the growth hormone
 signal transduction.