Effects of Growth Hormone (GH) Treatment on Eating Regulation

NCT00562705 | Completed

• 1 other identifier: rmc004623ctil
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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:

1. 1.Control group that will continue with growth hormone treatment without any other intervention.
2. 2.Study group that will be a given a nutritional intervention in addition to growth hormone treatment.

Conditions

Short Stature

Keywords

growth hormone; eating regulation; nutritional intervention; short stature; ISS; SGA; IGHD; MPHD

Outcome Measures

Primary Outcomes (2)

• height and weight

  every visit until the end of study

• Growth markers

  At screening visit, baseline and at the end of the visit

Secondary Outcomes (3)

• Safety laboratory parameters

  at screening, baseline and at the end of the study

• food diary

  every visit until the end of the study

• Resting energy expenditure measurements

  Every visit other than visit number 4

Study Arms (2)

1

EXPERIMENTAL

Growth hormone and nutritional intervention

Behavioral: growth hormone- Genotropin or NorditropinSimplex and nutritional intervention

2

ACTIVE COMPARATOR

growth hormone

Behavioral: growth hormone-Genotropin or NorditropinSimplex or "Biotropin"

Interventions

growth hormone- Genotropin or NorditropinSimplex and nutritional intervention BEHAVIORAL

A combined treatment of growth hormone (Genotropin or NorditropinSimplex or "Biotropin") and nutritional intervention

1

growth hormone-Genotropin or NorditropinSimplex or "Biotropin" BEHAVIORAL

Growth hormone treatment (Genotropin, or NorditropinSimplex or "Biotropin").

2

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rabin Medical Center: lead

Study Sites (1)

Schneider Children's Medical Center

Petah Tikva, Israel

Location

MeSH Terms

Conditions

Dwarfism

Condition Hierarchy (Ancestors)

Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Endocrine System Diseases

Study Officials

• Moshe Phillip, Professor

  Schneider Children Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2007
• First Posted: November 22, 2007
• Study Start: January 1, 2008
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: July 16, 2013

Record last verified: 2013-07

Locations

IL (1)