Effects of Growth Hormone (GH) Treatment on Eating Regulation

July 15, 2013 updated by: Rabin Medical Center

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Petach-Tikva, Israel
        • Schneider Children's Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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").

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
height and weight
Time Frame: every visit until the end of study
every visit until the end of study
Growth markers
Time Frame: At screening visit, baseline and at the end of the visit
At screening visit, baseline and at the end of the visit

Secondary Outcome Measures

Outcome Measure
Time Frame
Safety laboratory parameters
Time Frame: at screening, baseline and at the end of the study
at screening, baseline and at the end of the study
food diary
Time Frame: every visit until the end of the study
every visit until the end of the study
Resting energy expenditure measurements
Time Frame: Every visit other than visit number 4
Every visit other than visit number 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rabin Medical Center

Investigators

  • Principal Investigator: Moshe Phillip, Professor, Schneider Children Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (Actual)

August 1, 2012

Study Completion (Actual)

August 1, 2012

Study Registration Dates

First Submitted

November 21, 2007

First Submitted That Met QC Criteria

November 21, 2007

First Posted (Estimate)

November 22, 2007

Study Record Updates

Last Update Posted (Estimate)

July 16, 2013

Last Update Submitted That Met QC Criteria

July 15, 2013

Last Verified

July 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • rmc004623ctil

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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