Effects of Growth Hormone (GH) Treatment on Eating Regulation

Tracking Information
First Submitted Date ICMJE	November 21, 2007
First Posted Date ICMJE	November 22, 2007
Last Update Posted Date	July 16, 2013
Study Start Date ICMJE	January 2008
Actual Primary Completion Date	August 2012 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: December 9, 2007)	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 ]
Original Primary Outcome Measures ICMJE; (submitted: November 21, 2007)	height and weight [ Time Frame: every visit until the end of study ]
Change History	Complete list of historical versions of study NCT00562705 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: December 9, 2007)	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 ]
Original Secondary Outcome Measures ICMJE; (submitted: November 21, 2007)	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 ]
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Effects of Growth Hormone (GH) Treatment on Eating Regulation
Official Title ICMJE	Effects of Growth Hormone Treatment on Eating Regulation and Comparison Between the Growth Responses With or Without Nutritional Intervention in Short Stature Children
Brief 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: Control group that will continue with growth hormone treatment without any other intervention.; 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: To evaluate the effect of short term growth hormone treatment on the following parameters: Appetite, food preference, amount of food and ingredients. Changes in food regulations. Changes in body composition. Changes in resting energy expenditure. Changes in hormones that are associated with appetite and with energy balance: IGF-1,IGFBP1&3 and Ghrelin. Changes in metabolic and nutritional measurements: glucose, insulin, lipid profile, total proteins, albumin, liver functions, alkaline-phosphatase, hemoglobin, transferrin, iron, B12, folic acid.; 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: Control group that will continue with growth hormone treatment without any other intervention.; 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.
Study Type ICMJE	Interventional
Study Phase	Not Applicable
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition ICMJE	Short Stature
Intervention ICMJE	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").
Study Arms	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"
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: July 15, 2013)	32
Original Estimated Enrollment ICMJE; (submitted: November 21, 2007)	30
Actual Study Completion Date	August 2012
Actual Primary Completion Date	August 2012 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	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: IGHD or MPHD ISS SGA; Proper function of thyroid gland, kidney and liver; Prior to initiating growth hormone treatment Exclusion Criteria: Chronic diseases; Diseases in the digestive system.; Neurological diseases.; Malignant diseases in the past or in the present. Treated with chemotherapy or radiation.; Genetic syndromes; Bone diseases; Taking chronic medicine, SSRI type, that effect the appetite and the growth hormone signal transduction.
Sex/Gender	Sexes Eligible for Study: All
Ages	2 Years to 18 Years (Child, Adult)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	Israel
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00562705
Other Study ID Numbers ICMJE	rmc004623ctil
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Rabin Medical Center
Study Sponsor ICMJE	Rabin Medical Center
Collaborators ICMJE	Not Provided
Investigators ICMJE	Principal Investigator: Moshe Phillip, Professor Schneider Children Medical Center
PRS Account	Rabin Medical Center
Verification Date	July 2013
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP