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Study of the Molecular Basis in the Pathophysiology of Food Intake and Growth in Children (Ghrelin)

2 juillet 2015 mis à jour par: Yardena Tenenbaum-Rakover, HaEmek Medical Center, Israel

Obesity, now a global epidemic, is a leading cause of illness and mortality in the developed world. To better understand the pathophysiological mechanisms that underlie weight disorders, increasing attention is being paid to central regulatory elements in energy homeostasis, including food intake and energy expenditure. The human hormone ghrelin is secreted as a preprohormone (preproghrelin), from which two hormones with antagonistic effects are derived: ghrelin, which has orexigenic effects and obestatin, which has anorexigenic effects. Ghrelin's actions are mediated by GH secretagogue receptor (GHSR). Ghrelin synthesis occurs predominantly in epithelial cells of the fundus of the stomach. . As the ligand for GHSR, ghrelin stimulates secretion of GH. In both rodents and humans, ghrelin regulates hunger though its action on hypothalamic feeding centers. Other effects of ghrelin include stimulating gastric emptying, positive effects on cardiovascular function, increasing intestinal peristalsis, and positive exocrine and paracrine pancreatic secretion. Despite its important physiological role, its precise regulatory mechanisms remain ambiguous. Thus, it has been suggested that mutations in ghrelin and its receptor will present clinically with obesity, eating disorders or growth disturbances. To date, only four different mutations have been reported in GHSR and no mutations have been found in the ghrelin gene.

Working hypothesis and aims: We hypothesize that mutations in ghrelin or in its receptor, GHSR, affect appetite regulation and cause growth and eating disorders.

Aperçu de l'étude

Statut

Complété

Les conditions

Description détaillée

Background: Obesity, now a global epidemic, is a leading cause of illness and mortality in the developed world. To better understand the pathophysiological mechanisms that underlie weight disorders, increasing attention is being paid to central regulatory elements in energy homeostasis, including food intake and energy expenditure. The human hormone ghrelin is secreted as a preprohormone (preproghrelin), from which two hormones with antagonistic effects are derived: ghrelin, which has orexigenic effects and obestatin, which has anorexigenic effects. Ghrelin's actions are mediated by GH secretagogue receptor (GHSR). Ghrelin synthesis occurs predominantly in epithelial cells of the fundus of the stomach. . As the ligand for GHSR, ghrelin stimulates secretion of GH. In both rodents and humans, ghrelin regulates hunger though its action on hypothalamic feeding centers. Other effects of ghrelin include stimulating gastric emptying, positive effects on cardiovascular function, increasing intestinal peristalsis, and positive exocrine and paracrine pancreatic secretion. Despite its important physiological role, its precise regulatory mechanisms remain ambiguous. Thus, it has been suggested that mutations in ghrelin and its receptor will present clinically with obesity, eating disorders or growth disturbances. To date, only four different mutations have been reported in GHSR and no mutations have been found in the ghrelin gene.

Working hypothesis and aims: We hypothesize that mutations in ghrelin or in its receptor, GHSR, affect appetite regulation and cause growth and eating disorders.

Methods: A total of 250 children followed in the pediatric endocrine department at Ha'Emek Medical Center will be divided into four groups: 50 children with GH deficiency, 50 obese children, 50 children with failure to thrive (FTT),and 50 children with idiopathic short stature (ISS). In addition, 50 children without growth or weight disorders will be included as a control group.

Genomic DNA will be isolated from the peripheral blood by standard methods. The corresponding intron-exon boundaries of the ghrelin and GHSR genes will be analyzed by direct sequencing using an ABI Prism 3100 DNA Analyzer.

Expected results: We anticipate that mutations in ghrelin or its receptor will affect growth and appetite regulation.

Importance: The findings of this study will expand our understanding of ghrelin's role in growth and appetite regulation.

Probable implications for medicine: The development of more specific therapeutic modalities for the treatment of short stature and obesity in children may become possible.

Type d'étude

Observationnel

Inscription (Réel)

259

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

Pas plus vieux que 18 ans (Enfant, Adulte)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

Méthode d'échantillonnage

Échantillon de probabilité

Population étudiée

A total of 250 children followed in the pediatric endocrine department at Ha'Emek Medical Center will be divided into 5 groups: 50 children with GH deficiency,50 obese children, 50 children with failure to thrive (FTT)and 50 children with idiopathic short stature (ISS). 50 children without growth and weight disorders will be included as a control group.

La description

Inclusion Criteria:

  • Group1: Children with GH deficiency diagnosed by 2 provocative tests with peak GH less than 10 ng/ml.
  • Group 2:Children with height less than the 3rd centile without any etiology
  • Group 3:children with failure to thrive until the age of 3 years.
  • Group 4: children with obesity defined by BMI above the 90th centile for age and sex.
  • Group 5: children with no endocrine diseases and without obesity or short stature.

Exclusion Criteria:

  • Children with known pediatric or endocrine diseases.

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

Cohortes et interventions

Groupe / Cohorte
1
50 children with GH deficiency
2
50 children with ISS
3
50 children with FTT
4
50 children with obesity
5
50 children without short stature or obesity will serve as controls

Collaborateurs et enquêteurs

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

Les enquêteurs

  • Chercheur principal: Yardena Tenenbaum-Rakover, MD, Ha"Emek Medical Center, Afula, ISRAEL

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

1 janvier 2009

Achèvement primaire (Réel)

1 janvier 2011

Achèvement de l'étude (Réel)

1 janvier 2012

Dates d'inscription aux études

Première soumission

25 janvier 2009

Première soumission répondant aux critères de contrôle qualité

26 janvier 2009

Première publication (Estimation)

27 janvier 2009

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Estimation)

3 juillet 2015

Dernière mise à jour soumise répondant aux critères de contrôle qualité

2 juillet 2015

Dernière vérification

1 juillet 2015

Plus d'information

Termes liés à cette étude

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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