An observational study in Growth Hormone Deficiency, sponsored by Columbia University. Not yet recruiting. Open to participants aged 5 Years to 17 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-25.
Sponsored by Columbia University · Observational
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.
Protocol 1 This will be a cross-sectional study in 140 healthy children. Participation will include one visit that will take place between 8-9 am and after a fast from midnight the night before.
Procedures at the visit will include:
Protocol 2 This will be a prospective study in 16 children who will be studied before and at 4 time points (1 week, 2 weeks, 1 month and 2 months) after starting GH treatment as part of their clinical care. This protocol will study subjects Groups 2 and 3. Growth hormone will not be prescribed as part of this study. Children will be treated clinically with GH as prescribed by their Pediatric Endocrinologist for FDA approved indications and according to standard guidelines for dosing for treatment of GH deficiency in children.
Each visit that will take place between 8-9 am and after a fast from midnight the night before.
Procedures at each visit will include:
Baseline (pre-GH treatment): measurement of AgRP, GH, IGF-1, IGFBP-3, leptin, SOb-R, triglycerides, insulin and glucose, testosterone(males), estradiol(females), DHEAS and cortisol levels.
Follow up visits on growth hormone: measurement of AgRP, IGF-1, IGFBP-3, leptin, SOb-R, triglycerides, insulin, glucose and cortisol levels.
Insulin and glucose levels will be used to assess insulin resistance by HOMA \& QUICKI.
252 studies on the registry are indexed under Dwarfism, Pituitary; 30 are open to participants now.
This study's planned enrollment of 156 is above the median of 70 across 73 observational studies indexed under Dwarfism, Pituitary.
Browse Dwarfism, Pituitary studies →Columbia University is the lead sponsor of 1,136 studies on the registry; 195 are open to participants now.
Of its 180 completed or terminated interventional studies of FDA-regulated products, 148 (82%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
Healthy children
Inclusion Criteria:
Exclusion Criteria:
Children with GH deficiency:
Inclusion Criteria:
Exclusion criteria:
Children with idiopathic Short Stature:
Inclusion Criteria:
Exclusion criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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. Inclusion Criteria: 1. Ambulatory male and female children aged 5-17 years 2. Normal weight at birth 3. Height between the 3rd and 99th percentiles of the mean as per the CDC growth percentiles. Exclusion Criteria: 1. Genetic defects, chronic illnesses. 2. Current prescription medication use 3. Use of glucocorticoids, thyroid hormone or medications that may affect the GH-IGF-1 axis within 6 months of study entry.
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. GH deficiency: Inclusion Criteria: 1. Ambulatory male and female children aged 5-9 years who are prepubertal 2. Normal weight at birth 3. Growth failure 4. Peak GH response to 2 GH stimulation tests \< 10 ng/ml 5. Normal renal and liver function Exclusion criteria: 1. Multiple pituitary hormone deficiencies, 2. GH deficiency or poor growth associated with any acute or chronic medical condition such as renal disease or Turner's syndrome. 3. History of diabetes or malignancy 4. Use of glucocorticoids or medications known to affect the GH-IGF-1 axis within 6 months of study entry.
Idiopathic Short Stature: Inclusion Criteria: 1. Ambulatory male and female children aged 5-9 years who are prepubertal 2. Normal weight at birth 3. Height \>2.25 SD below mean for age 4. Peak GH response to 2 stimulation tests \>10 ng/ml or normal IGF-1 and IGFBP-3 levels 5. No prior supplemental growth hormone exposure 6. Normal renal and liver function Exclusion criteria: 1. Poor growth associated with any acute or chronic medical condition such as renal disease or Turner's syndrome. 2. History of diabetes or malignancy 3. Use of glucocorticoids or medications known to affect the GH-IGF-1 axis within 6 months of study entry.
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)
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 months
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)
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)
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)
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 months
Protocol 2: Change in AgRP level correlation with pre-treatment leptin levels
Correlation of change in AgRP level from baseline to 2 months of GH therapy with pre-treatment leptin levels
Time frame: Baseline to 2 months
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Jun 2027; primary completion for Dec 2027, 6 months later.
Start moved once since we started tracking on Sep 25, 2026: Jun 2026 → Jun 2027, on Sep 25, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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