Growth Hormone Secretion Following the Anaerobic Exercise

Sponsor
Meir Medical Center (Other)
Overall Status
Unknown status
CT.gov ID
NCT01934270
Collaborator
(none)
100
1
1
70
1.4

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Anaerobic Test
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Growth Hormone Secretion Following the Anaerobic Exercise
Actual Study Start Date :
May 1, 2014
Anticipated Primary Completion Date :
Dec 30, 2019
Anticipated Study Completion Date :
Mar 1, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Anaerobic Test

Other: Anaerobic Test
To evaluate the secretion of growth hormone in response to anaerobic exercise in children.

Outcome Measures

Primary Outcome Measures

  1. Growth Hormone Release [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 Measures

  1. IGF-1 and Cortisol Release [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]

Eligibility Criteria

Criteria

Ages Eligible for Study:
6 Years to 16 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Children evaluated for short stature

  • Normal weight \ overweight \ obesity

Exclusion Criteria:
  • Known GH deficiency

Contacts and Locations

Locations

Site City State Country Postal Code
1 Meir Medical Center Kfar Saba Israel

Sponsors and Collaborators

  • Meir Medical Center

Investigators

  • Principal Investigator: Dan Nemet, MD, Meir Medical Center , Tel Aviv University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Dan Nemet, MD, Prof. of Pediatric, MD, Meir Medical Center
ClinicalTrials.gov Identifier:
NCT01934270
Other Study ID Numbers:
  • MeirMc094-13CTIL
First Posted:
Sep 4, 2013
Last Update Posted:
Oct 15, 2019
Last Verified:
Oct 1, 2019
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 15, 2019