Effects of Growth Hormone (GH) Treatment on Eating Regulation
Condition: Short Stature
MeSH terms: Dwarfism
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): growth hormone- Genotropin or NorditropinSimplex and nutritional intervention; growth hormone-Genotropin or NorditropinSimplex or "Biotropin"
Intervention type(s): Behavioral; Behavioral
Intervention description(s): A combined treatment of growth hormone (Genotropin or NorditropinSimplex or "Biotropin") and nutritional intervention; Growth hormone treatment (Genotropin, or NorditropinSimplex or "Biotropin").
Intervention MeSH terms: Hormones
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: growth hormone; eating regulation; nutritional intervention; short stature; ISS; SGA; IGHD; MPHD