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L'axe AgRP et GH/IGF-1 chez les enfants

22 septembre 2026 mis à jour par: Pamela U. Freda, Columbia University

Peptide lié à l'agouti (AgRP) et l'axe GH/IGF-1 chez les enfants

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.

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Description détaillée

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.

Type d'étude

Observationnel

Inscription (Estimé)

156

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Sauvegarde des contacts de l'étude

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

5 ans à 17 ans (Enfant)

Accepte les volontaires sains

Oui

Sexes éligibles pour l'étude

Tout

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

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.

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Modèles d'observation: COHORT
  • Perspectives temporelles: CROSS_SECTIONAL

Cohortes et interventions

Groupe / Cohorte
Group 1: 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.

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.
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.

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.
Group 3: Children with short stature

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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Protocol 1: Correlation of Plasma AgRP levels with IGF-1 levels
Délai: Baseline (cross-sectional at single time point, no intervention)

Plasma AgRP levels correlation with IGF-1 levels Protocol 1: Correlation of Plasma AgRP levels with IGF-1 levels
Baseline (cross-sectional at single time point, no intervention)
Protocol 2: Change in plasma AgRP levels with GH therapy
Délai: baseline to 2 months

Change in plasma AgRP levels from pre-GH therapy to post-GH therapy
baseline to 2 months

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Protocol 1: Correlation of plasma AgRP levels with age
Délai: Baseline (cross-sectional testing at one time point, no intervention)

Correlation of plasma AgRP levels with age
Baseline (cross-sectional testing at one time point, no intervention)
Protocol 1: Correlation of plasma AgRP levels with leptin levels
Délai: Baseline (cross-sectional testing at one time point, no intervention)

Correlation of plasma AgRP levels with leptin levels
Baseline (cross-sectional testing at one time point, no intervention)
Protocol 1: Correlation of plasma AgRP with percent body fat (determined from skinfold thickness)
Délai: Baseline (cross-sectional testing at one time point, no intervention)

Correlation of plasma AgRP with percent body fat (determined from skinfold thickness)
Baseline (cross-sectional testing at one time point, no intervention)
Protocol 2: Change in AgRP levels correlation with change in IGF-1 levels
Délai: Baseline to 2 months

Correlation of change in AgRP levels with change in IGF-1 levels from baseline to 2 months of GH therapy
Baseline to 2 months
Protocol 2: Change in AgRP level correlation with pre-treatment leptin levels
Délai: Baseline to 2 months

Correlation of change in AgRP level from baseline to 2 months of GH therapy with pre-treatment leptin levels
Baseline to 2 months

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Columbia University

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

10 juin 2027

Achèvement primaire (Estimé)

31 décembre 2027

Achèvement de l'étude (Estimé)

31 décembre 2027

Dates d'inscription aux études

Première soumission

30 novembre 2022

Première soumission répondant aux critères de contrôle qualité

8 décembre 2022

Première publication (Réel)

9 décembre 2022

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

25 septembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

22 septembre 2026

Dernière vérification

1 septembre 2026

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • AAAU4134

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

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