Effects of Growth Hormone (GH) Treatment on Eating Regulation

Short Stature Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00562705
• Other study ID #: rmc004623ctil
• Status: Completed
• Phase: N/A
• First received: November 21, 2007
• Last updated: July 15, 2013
• Start date: January 2008
• Est. completion date: August 2012

Study information

• Verified date: July 2013
• Source: Rabin Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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:

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 18 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dwarfism
• Short Stature

Intervention

Behavioral:
• growth hormone- Genotropin or NorditropinSimplex and nutritional intervention
A combined treatment of growth hormone (Genotropin or NorditropinSimplex or "Biotropin") and nutritional intervention
• growth hormone-Genotropin or NorditropinSimplex or "Biotropin"
Growth hormone treatment (Genotropin, or NorditropinSimplex or "Biotropin").

Locations

Country	Name	City	State
Israel	Schneider Children's Medical Center	Petach-Tikva

Sponsors (1)

Lead Sponsor	Collaborator
Rabin Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	height and weight		every visit until the end of study	No
Primary	Growth markers		At screening visit, baseline and at the end of the visit	No
Secondary	Safety laboratory parameters		at screening, baseline and at the end of the study	Yes
Secondary	food diary		every visit until the end of the study	No
Secondary	Resting energy expenditure measurements		Every visit other than visit number 4	No