Effects of Growth Hormone (GH) Treatment on Eating Regulation

• height and weight [ Time Frame: every visit until the end of study ] [ Designated as safety issue: No ]
  
• Growth markers [ Time Frame: At screening visit, baseline and at the end of the visit ] [ Designated as safety issue: No ]
  

• Safety laboratory parameters [ Time Frame: at screening, baseline and at the end of the study ] [ Designated as safety issue: Yes ]
  
• food diary [ Time Frame: every visit until the end of the study ] [ Designated as safety issue: No ]
  
• Resting energy expenditure measurements [ Time Frame: Every visit other than visit number 4 ] [ Designated as safety issue: No ]
  

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.