The AgRP and GH/IGF-1 Axis in Children

Launched by COLUMBIA UNIVERSITY · Dec 8, 2022

Keywords

ClinConnect Summary

This clinical trial, titled "The AgRP and GH/IGF-1 Axis in Children," aims to understand how certain hormones, specifically growth hormone (GH) and agouti-related peptide (AgRP), interact and affect children with growth hormone deficiency. Researchers want to measure AgRP levels in healthy children and see how these levels change in response to GH treatment in children who need it due to growth issues. The study includes two parts: one will look at 140 healthy children aged 5 to 17 years, and the other will focus on 16 children with growth hormone deficiency who are receiving treatment.

To be eligible for the study, participants need to be healthy children between the ages of 5 and 17, with specific height and weight criteria. For children with growth hormone deficiency, they should be aged 5 to 9, show signs of growth failure, and have certain test results confirming low GH levels. Participants can expect to provide blood samples for testing, which will help researchers learn more about how these hormones work together in children. It’s important to note that children with certain medical conditions or those taking specific medications within the last six months may not be eligible to participate.

Gender

ALL

Eligibility criteria

• • Healthy children
• 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.
• Children with 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.
• Children with 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.