Deze pagina is automatisch vertaald en de nauwkeurigheid van de vertaling kan niet worden gegarandeerd. Raadpleeg de Engelse versie voor een brontekst.

De AgRP- en GH/IGF-1-as bij kinderen

22 september 2026 bijgewerkt door: Pamela U. Freda, Columbia University

Agouti-gerelateerd peptide (AgRP) en de GH/IGF-1-as bij kinderen

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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Gedetailleerde beschrijving

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.

Studietype

Observationeel

Inschrijving (Geschat)

156

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Contact Back-up

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

5 jaar tot 17 jaar (Kind)

Accepteert gezonde vrijwilligers

Ja

Geslachten die in aanmerking komen voor studie

Allemaal

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

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.

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Observatiemodellen: COHORT
  • Tijdsperspectieven: CROSS_SECTIONAL

Cohorten en interventies

Groep / Cohort
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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Protocol 1: Correlation of Plasma AgRP levels with IGF-1 levels
Tijdsspanne: 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
Tijdsspanne: baseline to 2 months

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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Protocol 1: Correlation of plasma AgRP levels with age
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Columbia University

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

10 juni 2027

Primaire voltooiing (Geschat)

31 december 2027

Studie voltooiing (Geschat)

31 december 2027

Studieregistratiedata

Eerst ingediend

30 november 2022

Eerst ingediend dat voldeed aan de QC-criteria

8 december 2022

Eerst geplaatst (Werkelijk)

9 december 2022

Updates van studierecords

Laatste update geplaatst (Werkelijk)

25 september 2026

Laatste update ingediend die voldeed aan QC-criteria

22 september 2026

Laatst geverifieerd

1 september 2026

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • AAAU4134

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Abonneren