The AgRP and GH/IGF-1 Axis in Children
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Growth Hormone Deficiency. Basic parameters: 5 years — 17 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Agouti-related Peptide (AgRP) and the GH/IGF-1 Axis in Children
Overview
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.
Detailed description
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:
1. Review of medical history 2. Anthropometrics measurements: Weight, height, waist and hip circumferences. 3. Collection of information from medical record including growth records and physical examination findings including features relevant to pubertal stage in all children and onset of menses in females. 4. Assessment of pubertal status and Tanner stage based on physical examination. 5. Collection of information on diet, activity level and sleep. 6. Blood Sampling: venous blood will be sampled from a peripheral vein for measurement of AgRP, GH, IGF-1, leptin, SOb-R, triglycerides, insulin, glucose, testosterone(males), estradiol(females), DHEAS and cortisol levels. Insulin and glucose levels will be used to assess insulin resistance by HOMA \& QUICKI.
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:
1. Review of medical history 2. Anthropometrics measurements: Weight, height, waist and hip circumferences, skinfold thicknesses. 3. Collection of information from medical record including growth records and physical examination findings including features relevant to pubertal stage in all children and onset of menses in females. GH dose and compliance will be recorded at follow up visits. 4. Collection of information on diet, activity level and sleep. 5. Blood Sampling: Venous blood will be sampled at a peripheral vein for:
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.
Primary outcome measures
- 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 [Time frame: baseline to 2 months]
Secondary outcome measures (5)
- Protocol 1: 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 [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) [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 [Time frame: Baseline to 2 months]
- Protocol 2: Change in AgRP level correlation with pre-treatment leptin levels [Time frame: Baseline to 2 months]
Eligibility criteria
Healthy children
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Children with GH deficiency:
Inclusion criteria
- Ambulatory male and female children aged 5-9 years who are prepubertal
- Normal weight at birth
- Growth failure
- Peak GH response to 2 GH stimulation tests < 10 ng/ml
- Normal renal and liver function
Exclusion criteria
- Multiple pituitary hormone deficiencies,
- GH deficiency or poor growth associated with any acute or chronic medical condition such as renal disease or Turner's syndrome.
- History of diabetes or malignancy
- 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
- Ambulatory male and female children aged 5-9 years who are prepubertal
- Normal weight at birth
- Height >2.25 SD below mean for age
- Peak GH response to 2 stimulation tests >10 ng/ml or normal IGF-1 and IGFBP-3 levels
- No prior supplemental growth hormone exposure
- Normal renal and liver function
Exclusion criteria
- Poor growth associated with any acute or chronic medical condition such as renal disease or Turner's syndrome.
- History of diabetes or malignancy
- Use of glucocorticoids or medications known to affect the GH-IGF-1 axis within 6 months of study entry.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT05645211 · AAAU4134