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Effects of Growth Hormone (GH) Treatment on Eating Regulation

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ClinicalTrials.gov Identifier: NCT00562705
Recruitment Status : Completed
First Posted : November 22, 2007
Last Update Posted : July 16, 2013
Sponsor:
Information provided by (Responsible Party):

November 21, 2007
November 22, 2007
July 16, 2013
January 2008
August 2012   (Final data collection date for primary outcome measure)
  • height and weight [ Time Frame: every visit until the end of study ]
  • Growth markers [ Time Frame: At screening visit, baseline and at the end of the visit ]
height and weight [ Time Frame: every visit until the end of study ]
Complete list of historical versions of study NCT00562705 on ClinicalTrials.gov Archive Site
  • Safety laboratory parameters [ Time Frame: at screening, baseline and at the end of the study ]
  • food diary [ Time Frame: every visit until the end of the study ]
  • Resting energy expenditure measurements [ Time Frame: Every visit other than visit number 4 ]
  • laboratory parameters and growth markers [ Time Frame: at screening, baseline and at the end of the study ]
  • food diary [ Time Frame: every visit until the end of the study ]
  • Resting energy expenditure measurements [ Time Frame: Every visit other than visit number 4 ]
Not Provided
Not Provided
 
Effects of Growth Hormone (GH) Treatment on Eating Regulation
Effects of Growth Hormone Treatment on Eating Regulation and Comparison Between the Growth Responses With or Without Nutritional Intervention in Short Stature Children

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Short Stature
  • Behavioral: growth hormone- Genotropin or NorditropinSimplex and nutritional intervention
    A combined treatment of growth hormone (Genotropin or NorditropinSimplex or "Biotropin") and nutritional intervention
  • Behavioral: growth hormone-Genotropin or NorditropinSimplex or "Biotropin"
    Growth hormone treatment (Genotropin, or NorditropinSimplex or "Biotropin").
  • Experimental: 1
    Growth hormone and nutritional intervention
    Intervention: Behavioral: growth hormone- Genotropin or NorditropinSimplex and nutritional intervention
  • Active Comparator: 2
    growth hormone
    Intervention: Behavioral: growth hormone-Genotropin or NorditropinSimplex or "Biotropin"
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
32
August 2012
August 2012   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
2 Years to 18 Years   (Child, Adult)
No
Contact information is only displayed when the study is recruiting subjects
Israel
 
 
NCT00562705
rmc004623ctil
No
Not Provided
Not Provided
Rabin Medical Center
Rabin Medical Center
Not Provided
Principal Investigator: Moshe Phillip, Professor Schneider Children Medical Center
Rabin Medical Center
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP