A Prospective Study of Outcome After Therapy for Acromegaly
Procédure Data
+ drug Data
+ diagnosticTest Data
Données recueillies dès le début de l'étude - ProspectiveMaladies osseuses+17
+ Maladies endocriniennes des os
+ Maladies du cerveau
Cohorte
Suivi d'un groupe de personnes dans le temps pour mieux comprendre les causes et l'évolution d'une maladie.Résumé
Date de début de l'étude : 1 septembre 2003
Date à laquelle le premier participant a commencé l'étude.Surgical removal of the pituitary tumor is the usual first form of treatment offered, but this is curative in only approximately 70% of patients. If not adequately treated, the disease can have significant morbidity largely due to the development of hypertension, diabetes and malignancy as well as possible loss of vision or other neurologic complications of a large pituitary mass. Inadequately treated acromegaly is also associated with a mortality rate 2-3 fold over the general population. All the mechanisms responsible for the increased morbidity and mortality in acromegaly as well as what biochemical criteria should be used during treatment in order to normalize the increased morbidity and mortality are not known. This study aims to follow patients with acromegaly prospectively from active disease through treatment in order to identify these factors.
Protocole
Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.280 participants à inclure
Nombre total de participants que l'essai clinique vise à recruter.Cohorte
Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Tout sexe
Le sexe biologique des participants éligibles à s'inscrire.À partir de 18 ans
Tranche d'âge des participants éligibles à participer.Volontaires sains autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Conditions
Pathologie
Critères
Acromegaly Subjects Inclusion Criteria: Adult males and females. Ages 18 and over. Presenting to the PI or one of the sub-investigators for evaluation of acromegaly. Must have a biochemical diagnosis of acromegaly consisting of an elevated serum insulin-like growth factor 1 (IGF-1) level. Supportive although not required for entry are an elevated growth hormone (GH) level and a failure of GH to suppress normally after oral glucose administration. Willingness to participate in this study's procedures. Exclusion Criteria: Subjects who are unwilling to comply with the procedures outlined in the study. Subjects who do not have the ability to fully comprehend the nature of the study, to follow instructions, and/or cooperate with study procedures Are unwilling to provide informed consent to participate in the study. Healthy Subjects Inclusion Criteria: Adult males and females. Ages 18 and over. Responding to ads for participation or by word of mount. No medical problems, no medications, stable weight for 3 months prior to study. Willingness to participate in this study's procedures. Exclusion Criteria: Subjects who are unwilling to comply with the procedures outlined in the study. Subjects who do not have the ability to fully comprehend the nature of the study, to follow instructions, and/or cooperate with study procedures Are unwilling to provide informed consent to participate in the study. Failure to meet the inclusion criteria.
Plan de l'étude
Découvrez tous les traitements administrés dans cette étude, leur description détaillée et ce qu'ils impliquent.2 groupes d'intervention sont désignés dans cette étude
Cette étude ne comporte pas de groupe placebo.
Groupes de traitement
Objectifs de l'étude
Objectifs principaux
Objectifs secondaires
Centres d'étude
Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.Cette étude comporte 1 site
Neuroendocrine Unit; Columbia University Medical Center, 180 Fort Washington Avenue 9-970
New York, United StatesOuvrir Neuroendocrine Unit; Columbia University Medical Center, 180 Fort Washington Avenue 9-970 dans Google Maps