[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100488830":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":10,"centralContacts":18,"locations":10,"responsibleParty":28,"collaborators":10,"id":32,"slug":33,"hasResults":34,"nctId":35,"briefTitle":36,"officialTitle":37,"acronym":10,"eligibilityCriteria":38,"healthyVolunteers":39,"sex":40,"minAge":41,"maxAge":42,"enrollmentInfo":43,"targetDuration":10,"studyType":46,"phases":10,"briefSummary":47,"conditions":48,"keywords":10,"overallStatus":50,"whyStopped":10,"lastUpdateSubmitDate":51,"lastUpdatePostDateStruct":52,"startDateStruct":55,"completionDateStruct":57,"leadSponsor":59,"locationsCount":10},{"fullName":5,"class":6},"Columbia University","OTHER",[8,12,15],{"label":9,"type":10,"description":11,"interventionNames":10},"Group 1: Healthy children",null,"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.\n\nInclusion Criteria:\n\n1. Ambulatory male and female children aged 5-17 years\n2. Normal weight at birth\n3. Height between the 3rd and 99th percentiles of the mean as per the CDC growth percentiles.\n\nExclusion Criteria:\n\n1. Genetic defects, chronic illnesses.\n2. Current prescription medication use\n3. Use of glucocorticoids, thyroid hormone or medications that may affect the GH-IGF-1 axis within 6 months of study entry.",{"label":13,"type":10,"description":14,"interventionNames":10},"Group 2: Children with GH deficiency","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.\n\nThey will be representative of the diverse racial and ethnic mix of our hospital's patient population.\n\nGH deficiency:\n\nInclusion Criteria:\n\n1. Ambulatory male and female children aged 5-9 years who are prepubertal\n2. Normal weight at birth\n3. Growth failure\n4. Peak GH response to 2 GH stimulation tests \\\u003C 10 ng\u002Fml\n5. Normal renal and liver function\n\nExclusion criteria:\n\n1. Multiple pituitary hormone deficiencies,\n2. GH deficiency or poor growth associated with any acute or chronic medical condition such as renal disease or Turner's syndrome.\n3. History of diabetes or malignancy\n4. Use of glucocorticoids or medications known to affect the GH-IGF-1 axis within 6 months of study entry.",{"label":16,"type":10,"description":17,"interventionNames":10},"Group 3: Children with short stature","Idiopathic Short Stature:\n\nInclusion Criteria:\n\n1. Ambulatory male and female children aged 5-9 years who are prepubertal\n2. Normal weight at birth\n3. Height \\>2.25 SD below mean for age\n4. Peak GH response to 2 stimulation tests \\>10 ng\u002Fml or normal IGF-1 and IGFBP-3 levels\n5. No prior supplemental growth hormone exposure\n6. Normal renal and liver function\n\nExclusion criteria:\n\n1. Poor growth associated with any acute or chronic medical condition such as renal disease or Turner's syndrome.\n2. History of diabetes or malignancy\n3. Use of glucocorticoids or medications known to affect the GH-IGF-1 axis within 6 months of study entry.",[19,24],{"name":20,"role":21,"phone":22,"phoneExt":10,"email":23},"Pamela Freda","CONTACT","2123052254","puf1@cumc.columbia.edu",{"name":25,"role":21,"phone":26,"phoneExt":10,"email":27},"Rosa Lazarte","2123054921","rl2345@cumc.columbia.edu",{"type":29,"investigatorFullName":30,"investigatorTitle":31,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"PRINCIPAL_INVESTIGATOR","Pamela U. Freda","Professor of Medicine at CUIMC","100488830","the-agrp-and-ghigf-1-axis-in-children-100488830",false,"NCT05645211","The AgRP and GH\u002FIGF-1 Axis in Children","Agouti-related Peptide (AgRP) and the GH\u002FIGF-1 Axis in Children","Healthy children\n\nInclusion Criteria:\n\n1. Ambulatory male and female children aged 5-17 years\n2. Normal weight at birth\n3. Height between the 3rd and 99th percentiles of the mean as per the CDC growth percentiles.\n\nExclusion Criteria:\n\n1. Genetic defects, chronic illnesses.\n2. Current prescription medication use\n3. Use of glucocorticoids, thyroid hormone or medications that may affect the GH-IGF-1 axis within 6 months of study entry.\n\nChildren with GH deficiency:\n\nInclusion Criteria:\n\n1. Ambulatory male and female children aged 5-9 years who are prepubertal\n2. Normal weight at birth\n3. Growth failure\n4. Peak GH response to 2 GH stimulation tests \\\u003C 10 ng\u002Fml\n5. Normal renal and liver function\n\nExclusion criteria:\n\n1. Multiple pituitary hormone deficiencies,\n2. GH deficiency or poor growth associated with any acute or chronic medical condition such as renal disease or Turner's syndrome.\n3. History of diabetes or malignancy\n4. Use of glucocorticoids or medications known to affect the GH-IGF-1 axis within 6 months of study entry.\n\nChildren with idiopathic Short Stature:\n\nInclusion Criteria:\n\n1. Ambulatory male and female children aged 5-9 years who are prepubertal\n2. Normal weight at birth\n3. Height \\>2.25 SD below mean for age\n4. Peak GH response to 2 stimulation tests \\>10 ng\u002Fml or normal IGF-1 and IGFBP-3 levels\n5. No prior supplemental growth hormone exposure\n6. Normal renal and liver function\n\nExclusion criteria:\n\n1. Poor growth associated with any acute or chronic medical condition such as renal disease or Turner's syndrome.\n2. History of diabetes or malignancy\n3. Use of glucocorticoids or medications known to affect the GH-IGF-1 axis within 6 months of study entry.",true,"ALL","5 Years","17 Years",{"count":44,"type":45},156,"ESTIMATED","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.",[49],"Growth Hormone Deficiency","NOT_YET_RECRUITING","2025-08-25",{"date":53,"type":54},"2025-08-26","ACTUAL",{"date":56,"type":45},"2026-06-10",{"date":58,"type":45},"2027-12-31",{"name":5,"class":6}]