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

2 lipca 2015 zaktualizowane przez: 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.

Przegląd badań

Status

Zakończony

Szczegółowy opis

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.

Typ studiów

Obserwacyjny

Zapisy (Rzeczywisty)

259

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

Nie starszy niż 18 lat (Dziecko, Dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Metoda próbkowania

Próbka prawdopodobieństwa

Badana populacja

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.

Opis

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 studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

Kohorty i interwencje

Grupa / Kohorta
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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Śledczy

  • Główny śledczy: Yardena Tenenbaum-Rakover, MD, Ha"Emek Medical Center, Afula, ISRAEL

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów

1 stycznia 2009

Zakończenie podstawowe (Rzeczywisty)

1 stycznia 2011

Ukończenie studiów (Rzeczywisty)

1 stycznia 2012

Daty rejestracji na studia

Pierwszy przesłany

25 stycznia 2009

Pierwszy przesłany, który spełnia kryteria kontroli jakości

26 stycznia 2009

Pierwszy wysłany (Oszacować)

27 stycznia 2009

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Oszacować)

3 lipca 2015

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

2 lipca 2015

Ostatnia weryfikacja

1 lipca 2015

Więcej informacji

Terminy związane z tym badaniem

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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