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Growth Hormone Secretion Following the Anaerobic Exercise

Primary Purpose

Short Stature, Obesity, Childhood

Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Anaerobic Test
Sponsored by
Meir Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Short Stature

Eligibility Criteria

6 Years - 16 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Children evaluated for short stature
  • Normal weight \ overweight \ obesity

Exclusion Criteria:

  • Known GH deficiency

Sites / Locations

  • Meir Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Anaerobic Test

Arm Description

Outcomes

Primary Outcome Measures

Growth Hormone Release

Secondary Outcome Measures

IGF-1 and Cortisol Release

Full Information

First Posted
August 19, 2013
Last Updated
October 11, 2019
Sponsor
Meir Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01934270
Brief Title
Growth Hormone Secretion Following the Anaerobic Exercise
Official Title
Growth Hormone Secretion Following the Anaerobic Exercise
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Unknown status
Study Start Date
May 2014 (Actual)
Primary Completion Date
December 30, 2019 (Anticipated)
Study Completion Date
March 1, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Meir Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Proper growth in children is a complex process regulated by a combination of genetic, nutritional, environmental, hormonal, and others. Growth hormone (GH) is the main hormone regulating the growth from childhood to adulthood. Despite great progress in the field, with the development of recombinant GH for the treatment of growth hormone deficiency (GHD), there is still no reliable method for testing GHD. Physical exertion is one of the significant physiologic stimuli for GH secretion, and it is reliable test for identification of GHD. It is not in use in the clinics because of its complexity. Recently GH secretion following short anaerobic exercise in young adults was tested and also demonstrated significant growth hormone secretion In contrast to adult children's exercise is characterized by an anaerobic nature. There is no data about secretion of growth hormone in response to anaerobic exercise in children. Purpose of the experiment: The purpose of this study is to evaluate the secretion of growth hormone in response to anaerobic exercise in children.
Detailed Description
100 children aged 6-16 years, followed at the pediatric endocrinology clinic for growth assessment or obesity. Assessment of their growth hormone axis will be evaluate in parallel according to the currently accepted pharmacological GH testing as accepted and also following anaerobic physical test. After explanation to the patient and his parent and obtaining an informed consent, the children will be instructed to pedal at maximum speed for 15 seconds x 10 sprints (1 minute of recovery between the sprints) against a resistance adjusted according to their body mass index. The test will perform in similarity to GH provocative protocols by mean that they will be performed in the morning after a night's sleep and overnight fasting. The patients will be remained fasting during the test. They will be asked not to exercise a day before the test. Thirty minutes before the test, Venflon will be inserted and the child will receive an explanation and rest until the beginning of the test. blood GH, IGF-1, cortisol will be taken at the beginning of exercise (time 0), at the end of exercise, after 30 minutes, 45 minutes and 60 minutes is customary according to criteria set pharmacological inventory growth hormone. The test results will be compared to pharmacological testing of the child if available.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Short Stature, Obesity, Childhood

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Anaerobic Test
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Anaerobic Test
Intervention Description
To evaluate the secretion of growth hormone in response to anaerobic exercise in children.
Primary Outcome Measure Information:
Title
Growth Hormone Release
Time Frame
GH will be measured at the beginning of exercise (time 0), and the change in GH level will be assessed at the end of exercise (30 seconds), after 10 minutes, 30 minutes and 60 minutes
Secondary Outcome Measure Information:
Title
IGF-1 and Cortisol Release
Time Frame
IGF-1, Cortisol will be taken at the beginning of exercise (time 0), at the end of exercise (30 seconds), after 10 minutes, 30 minutes and 60 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Children evaluated for short stature Normal weight \ overweight \ obesity Exclusion Criteria: Known GH deficiency
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dan Nemet, MD
Organizational Affiliation
Meir Medical Center , Tel Aviv University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Meir Medical Center
City
Kfar Saba
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dan Nemet, MD
Email
Dan.Nemet@clalit.org.il
First Name & Middle Initial & Last Name & Degree
Dan Nemet, MD

12. IPD Sharing Statement

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Growth Hormone Secretion Following the Anaerobic Exercise

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