Growth Hormone Secretion Following the Anaerobic Exercise

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified March 2014 by Meir Medical Center
Sponsor:
Information provided by (Responsible Party):
Dan Nemet, MD, Meir Medical Center
ClinicalTrials.gov Identifier:
NCT01934270
First received: August 19, 2013
Last updated: March 6, 2014
Last verified: March 2014
  Purpose

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 (Wingate test) in children.


Condition Intervention
Short Stature
Other: Anaerobic Test

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Growth Hormone Secretion Following the Anaerobic Exercise

Resource links provided by NLM:


Further study details as provided by Meir Medical Center:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: July 2014
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Anaerobic Test Other: Anaerobic Test
To evaluate the secretion of growth hormone in response to anaerobic exercise (Wingate test) in children.

Detailed Description:

40 children (20 boys and 20 girls) aged 6-16 years, followed at the endocrinology unit for short stature clinics and need 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 with the Wingate 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 30 seconds 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 (30 seconds), after 10 minutes, 30 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.

  Eligibility

Ages Eligible for Study:   6 Years to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

- Children evaluated for short stature

Exclusion Criteria:

  • Known GH deficiency
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01934270

Locations
Israel
Meir Medical Center Not yet recruiting
Kfar Saba, Israel
Principal Investigator: Dan Nemet, MD         
Sponsors and Collaborators
Meir Medical Center
Investigators
Principal Investigator: Dan Nemet, MD Meir Medical Center , Tel Aviv University
  More Information

No publications provided

Responsible Party: Dan Nemet, MD, Prof. of Pediatric, MD, Meir Medical Center
ClinicalTrials.gov Identifier: NCT01934270     History of Changes
Other Study ID Numbers: MeirMc094-13CTIL
Study First Received: August 19, 2013
Last Updated: March 6, 2014
Health Authority: Israel: Ministry of Health

Additional relevant MeSH terms:
Dwarfism
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Genetic Diseases, Inborn
Endocrine System Diseases
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 29, 2014