- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT00763477
Ghrelin in Cystic Fibrosis (ghrelin)
The Effect of Ghrelin on Appetite and Immune Function in Patients With Cystic Fibrosis
Background to ghrelin Ghrelin is a naturally occurring hormone found in the blood which stimulates appetite. In healthy individuals, levels of ghrelin are high before a meal and falls afterwards. Previous studies have shown that giving ghrelin (by injection) to thin patients with renal failure and cancer increases their food intake. Furthermore, addition of ghrelin may also reduce inflammation within the body. Cystic Fibrosis (CF) is a genetic disease which frequently results in recurrent lung infections (leading to progressive inflammatory lung damage) and low body weight. Low body weight in CF is associated with increased lung infections, rapidly worsening lung function and a shortened life expectancy.
The researchers postulate that administration of extra ghrelin to CF patients with low body weight may increase food intake and reduce lung inflammation. If successful, this study might identify ghrelin as a potential therapy for CF patients to improve nutrition, decrease lung inflammation and thereby improve survival.
Aperçu de l'étude
Description détaillée
The purpose of this study is to investigate the role of a naturally occuring hormone called ghrelin on appetite, energy expenditure and immune function in patients with cystic fibrosis.
Theoretical framework:
Despite advances in the molecular understanding of the disease, life-expectancy in Cystic Fibrosis (CF) remains severely limited. Reduced body-weight is associated with increased inflammatory lung damage and is a major predictor of mortality in CF patients. Malnutrition is highly prevalent in the CF population and results from both poor food intake and excessive energy expenditure. A therapy which improves nutrition may therefore have a significant effect on the prognosis of this disease. Ghrelin is the only physiological circulating factor that is known to increase food intake. Administration of acylated ghrelin to humans increases both hunger and food intake and has been found to increase appetite in chronic disease states associated with anorexia and weight loss (such as cancer and chronic renal disease). From multiple animal and in vitro human studies, ghrelin also appears to have anti-inflammatory properties which would potentially benefit CF patients in whom a chronic inflammatory state promotes lung destruction, malnutrition and increases mortality. Ghrelin replacement may therefore improve nutrition and decrease the inflammatory burden in CF patients, leading to an improvement in life-expectancy. If ghrelin is identified as having an important pathophysiological role in CF it may lead to a future study of its efficacy as a therapeutic agent.
Design Methodology: The study has three sections:
- a cross sectional study of the levels of blood metabolic signals in participants with cystic fibrosis and healthy controls.
- a laboratory study of the effect of ghrelin on immune cells extracted from the blood of participants with cystic fibrosis and healthy controls
- a cross-over interventional study of repeated ghrelin administration in malnourished cystic fibrosis patients
Type d'étude
Inscription (Anticipé)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Cambridgeshire
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Cambridge, Cambridgeshire, Royaume-Uni, CB23 3RE
- Recrutement
- Papworth Hospital NHS Foundation Trust
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Contact:
- Andres R Floto, BM BSc, PhD
- Numéro de téléphone: 01480 830541
- E-mail: andres.floto@papworth.nhs.uk
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Contact:
- Jane D Elliott, MPhil
- Numéro de téléphone: 01480 364495
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Chercheur principal:
- Andres Floto, MB BChir, PhD, FRCP
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Sous-enquêteur:
- Katie J Wynne, MB BChir, PhD, FRCP
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Cystic fibrosis
- BMI </=19 kg/m2
Exclusion Criteria:
- Needle phobia
- Pulmonary infection requiring intravenous antibiotics in the past 2 weeks-
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Recherche sur les services de santé
- Répartition: Randomisé
- Modèle interventionnel: Affectation croisée
- Masquage: Tripler
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Comparateur placebo: saline injections
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subcutaneous injection
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
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Appetite
Délai: 4 weeks
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4 weeks
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Mesures de résultats secondaires
Mesure des résultats |
Délai |
---|---|
lester
Délai: 4 semaines
|
4 semaines
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Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Anticipé)
Achèvement de l'étude (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- P01276
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