The AgRP and GH/IGF-1 Axis in Children
ConditionGrowth Hormone Deficiency
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age5-17
SponsorColumbia University
About this trial
Recent data support the existence of a GH-Agouti-related peptide (AgRP) axis. The neuropeptide AgRP promotes food intake and has important effects on energy homeostasis. Recent evidence suggest that GH stimulates AgRP and AgRP may mediate some of GH's important nutritional and metabolic effects. main goals of this project are to characterize, for the first time, plasma levels of AgRP in children and to determine how these relate to GH and IGF-1 levels, age, body composition, clinical and other endocrine parameters. To accomplish this, we will conduct two studies, one being a cross-sectional study that will measure AgRP levels in 140 healthy children ages 5-17 and the second being a prospective study that will measure the change in plasma AgRP levels in response to GH treatment in 16 children who receive this as part of their clinical care for GH deficiency or short stature.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Ambulatory male and female children aged 5-17 years
Normal weight at birth
Height between the 3rd and 99th percentiles of the mean as per the CDC growth percentiles.
Disqualifiers
Genetic defects, chronic illnesses.
Current prescription medication use
Use of glucocorticoids, thyroid hormone or medications that may affect the GH-IGF-1 axis within 6 months of study entry.
Ambulatory male and female children aged 5-9 years who are prepubertal
Trial population
Healthy children: 140 healthy children (70 females and 70 males) between the ages of 5-17 yr. will be studied; 7-8 children per year of this age range will be studied. They will be representative of the diverse racial and ethnic mix of children who receive their medical care at our medical center.Children will be recruited from among the healthy children visiting primary care Pediatricians at our medical center. GH deficient and idiopathic short stature children: 16 children (8 males, 8 females) between the ages of 5 - 9 yr. who are pre-pubertal and who plan to start GH treatment for isolated GH deficiency or idiopathic short stature. They will be representative of the diverse racial and ethnic mix of our hospital's patient population.
Trial design
Design model
Cohort
Time perspective
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
156 Participants
are grouped into 3 trial groupsGroup A: Group 1: Healthy children
Group B: Group 2: Children with GH deficiency
Group C: Group 3: Children with short stature
Trial outcomes
Primary outcomes
1
Protocol 1: Correlation of Plasma AgRP levels with IGF-1 levels
Plasma AgRP levels correlation with IGF-1 levels Protocol 1: Correlation of Plasma AgRP levels with IGF-1 levels
Time frame
Baseline (cross-sectional at single time point, no intervention)2
Protocol 2: Change in plasma AgRP levels with GH therapy
Change in plasma AgRP levels from pre-GH therapy to post-GH therapy
Time frame
baseline to 2 monthsSecondary outcomes
1
Protocol 1: Correlation of plasma AgRP levels with age
Correlation of plasma AgRP levels with age
Time frame
Baseline (cross-sectional testing at one time point, no intervention)2
Protocol 1: Correlation of plasma AgRP levels with leptin levels
Correlation of plasma AgRP levels with leptin levels
Time frame
Baseline (cross-sectional testing at one time point, no intervention)3
Protocol 1: Correlation of plasma AgRP with percent body fat (determined from skinfold thickness)
Correlation of plasma AgRP with percent body fat (determined from skinfold thickness)
Time frame
Baseline (cross-sectional testing at one time point, no intervention)4
Protocol 2: Change in AgRP levels correlation with change in IGF-1 levels
Correlation of change in AgRP levels with change in IGF-1 levels from baseline to 2 months of GH therapy
Time frame
Baseline to 2 monthsLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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