- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT03867448
Étude des affections endocriniennes et de la physiologie
L'évaluation et la gestion des affections endocriniennes et de la physiologie
Background:
Endocrine disorders involve changes to glands that produce hormones. Hormones are released by these glands into the blood so they can direct the function of other tissues in the body. Researchers want to study people who may have endocrine disorders. They want to learn more about the conditions that affect endocrine glands.
Objective:
To study adults with a variety of endocrine disorders for research and physician education.
Eligibility:
Adults ages 18 and older who have an endocrine or metabolic-related disorder
Healthy volunteers 18 and older
Design:
Participants will be screened with a review of their medical records.
Participants will have a physical exam and medical history.
The length of the study and the schedule will vary by participant. Tests may include:
Blood and urine tests
Stool and saliva samples
Imaging studies: Participants will lie on a table while a machine takes pictures of the body. They may be injected with a substance to make their organs more visible in the pictures.
Tests of endocrine tissue function
Consultation with other specialists
Sleep study
Medical photographs
Participants may be treated for their endocrine disorder. This could include:
Surgery. If tissue is removed during surgery, it may be studied.
Radiation
Medicine
Participants may have genetic testing. This will be done with a small amount of blood, cells from a cheek swab, or saliva.
Sponsoring Institution: National Institute of Digestive, Diabetes and Kidney Disease
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Study Description:
This study allows the NIH Intramural Endocrinology Training Program (IETP) to follow or provide evaluation, treatment and or interventions to certain eligible subjects.
Objectives:
- To provide a repository of data and samples obtained during the course of clinical care to allow for future research.
- To add value to the IEFP training program by maintaining a diverse group of endocrine conditions seen at the NIH.
- To provide a vehicle by which pilot studies of endocrine physiology can be initiated.
- To identify prismatic cases that deviate from known presentations or responses to treatment.
- To evaluate the safety and results from adrenal venous sampling using a modified catheter with side hole placement.
Endpoints:
- Data from standard of care evaluation and management.
- Adverse events during and after adrenal vein sampling; cortisol and aldosterone results from the sampling.
Type d'étude
Inscription (Estimé)
Contacts et emplacements
Coordonnées de l'étude
- Nom: Raven N McGlotten, R.N.
- Numéro de téléphone: (301) 827-0190
- E-mail: mcglottenr@mail.nih.gov
Sauvegarde des contacts de l'étude
- Nom: Lynnette K Nieman, M.D.
- Numéro de téléphone: (301) 496-8935
- E-mail: niemanl@mail.nih.gov
Lieux d'étude
-
-
Maryland
-
Bethesda, Maryland, États-Unis, 20892
- Recrutement
- National Institutes of Health Clinical Center
-
Contact:
- For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)
- Numéro de téléphone: TTY8664111010 800-411-1222
- E-mail: prpl@cc.nih.gov
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
any adult with a potential endocrine disorder; the types of disorders may vary to ensure that there is an adequate case mix of diagnoses for the training program.
La description
- INCLUSION CRITERIA:
In order to be eligible to participate in this study, an individual must meet all the following criteria:
- Adult men and women age 18 years or older.
- Known or suspected endocrine disorders requiring clinical screening, management and/or treatment and follow-up.
- Stated willingness to comply with all study procedures and availability for the duration of the study
EXCLUSION CRITERIA:
- Unstable participants and participants with severe organ failure, or those with a condition or medical treatment that may affect/limit the endocrine work-up and exhaust Clinical Center, IETP resources will be excluded if appropriate.
- Inability of a subject to adhere to a proposed schedule of visits.
- Inability to provide informed consent.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Modèles d'observation: CASE_ONLY
- Perspectives temporelles: PROSPECTIVE
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
|
Adults with Endocrine Disorder
Adults referred to NIH with possible endocrine conditions |
|
|
Adults with hyperaldosteronism
Adults referred to NIH or studied at NIH and determined to have hyperaldosteronism |
one or two side-holes will be created by the interventional radiologist to facilitate adrenal vein sampling |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Diagnosis/Treatment
Délai: variable
|
determination of diagnosis and/or treatment of an endocrine disorder |
variable
|
Collaborateurs et enquêteurs
Les enquêteurs
- Chercheur principal: Lynnette K Nieman, M.D., National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Publications et liens utiles
Liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 190066
- 19-DK-0066
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
WE currently have no plan to share this data, but in the future may consider sharing of this data for analysis with collaborators of with other expertise.
Informations sur les médicaments et les dispositifs, documents d'étude
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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 .