Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
40

Summary

Conditions
  • Obesity, Childhood
  • Short Stature
Type
Interventional
Phase
Not Applicable
Design
Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Diagnostic

Participation Requirements

Age
Between 6 years and 16 years
Gender
Both males and females

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. A...

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.

Tracking Information

NCT #
NCT01934270
Collaborators
Not Provided
Investigators
Principal Investigator: Dan Nemet, MD Meir Medical Center , Tel Aviv University