Effects of Growth Hormone (GH) Treatment on Eating Regulation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Rabin Medical Center
ClinicalTrials.gov Identifier:
NCT00562705
First received: November 21, 2007
Last updated: July 15, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention
Short Stature
Behavioral: growth hormone- Genotropin or NorditropinSimplex and nutritional intervention
Behavioral: growth hormone-Genotropin or NorditropinSimplex or "Biotropin"

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effects of Growth Hormone Treatment on Eating Regulation and Comparison Between the Growth Responses With or Without Nutritional Intervention in Short Stature Children

Resource links provided by NLM:


Further study details as provided by Rabin Medical Center:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 32
Study Start Date: January 2008
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Growth hormone and nutritional intervention
Behavioral: growth hormone- Genotropin or NorditropinSimplex and nutritional intervention
A combined treatment of growth hormone (Genotropin or NorditropinSimplex or "Biotropin") and nutritional intervention
Active Comparator: 2
growth hormone
Behavioral: growth hormone-Genotropin or NorditropinSimplex or "Biotropin"
Growth hormone treatment (Genotropin, or NorditropinSimplex or "Biotropin").

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.

  Eligibility

Ages Eligible for Study:   2 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00562705

Locations
Israel
Schneider Children's Medical Center
Petach-Tikva, Israel
Sponsors and Collaborators
Rabin Medical Center
Investigators
Principal Investigator: Moshe Phillip, Professor Schneider Children Medical Center
  More Information

No publications provided

Responsible Party: Rabin Medical Center
ClinicalTrials.gov Identifier: NCT00562705     History of Changes
Other Study ID Numbers: rmc004623ctil
Study First Received: November 21, 2007
Last Updated: July 15, 2013
Health Authority: Israel: Ministry of Health

Keywords provided by Rabin Medical Center:
growth hormone
eating regulation
nutritional intervention
short stature
ISS
SGA
IGHD
MPHD

Additional relevant MeSH terms:
Dwarfism
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Genetic Diseases, Inborn
Endocrine System Diseases
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014