NCT01934270

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 19, 2013

Completed
16 days until next milestone

First Posted

Study publicly available on registry

September 4, 2013

Completed
8 months until next milestone

Study Start

First participant enrolled

May 1, 2014

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2020

Completed
Last Updated

October 15, 2019

Status Verified

October 1, 2019

Enrollment Period

5.7 years

First QC Date

August 19, 2013

Last Update Submit

October 11, 2019

Conditions

Outcome Measures

Primary Outcomes (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 Outcomes (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

Study Arms (1)

Anaerobic Test

EXPERIMENTAL
Other: Anaerobic Test

Interventions

To evaluate the secretion of growth hormone in response to anaerobic exercise in children.

Anaerobic Test

Eligibility Criteria

Age6 Years - 16 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • Known GH deficiency

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Meir Medical Center

Kfar Saba, Israel

RECRUITING

MeSH Terms

Conditions

DwarfismPediatric Obesity

Condition Hierarchy (Ancestors)

Bone Diseases, DevelopmentalBone DiseasesMusculoskeletal DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesEndocrine System DiseasesObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Dan Nemet, MD

    Meir Medical Center , Tel Aviv University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. of Pediatric, MD

Study Record Dates

First Submitted

August 19, 2013

First Posted

September 4, 2013

Study Start

May 1, 2014

Primary Completion

December 30, 2019

Study Completion

March 1, 2020

Last Updated

October 15, 2019

Record last verified: 2019-10

Locations