- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00284895
The Effect of Obesity on Lung Functioning
The Effect of Medical and Surgical Weight Loss on Pulmonary Physiology and Airway
This research study is looking at the effects of weight loss, due to surgery or structured weight-loss program on lung function, inflammation in your body and lungs, asthma and asthma symptoms. This study is important because we will be better able to understand the effect of weight on lung functioning and asthma. Approximately 20 research subjects will be enrolling in this study at National Jewish.
Adults with asthma who has elected to undergo weight-reduction surgery may qualify for the participation. Involvement will last about 1 year.
Descripción general del estudio
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Colorado
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Denver, Colorado, Estados Unidos, 80206
- National Jewish Medical and Research Center
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Adults (≥18yr) who report a physician's diagnosis of asthma and have taken any asthma medication within the last 2 weeks.
- Obesity (Body Mass Index (BMI) ≥40, or ≥35 with comorbidities, as per published guidelines for qualification for bariatric surgery).
- Planned weight-loss surgery or structured weight-loss plan.
Exclusion Criteria:
- Tobacco use within one month.
- Qualifying lung-functioning.
- Qualifying oxygen saturation levels.
- Use of systemic corticosteroids (Prednisone) within one month.
- Presence of another chronic lung disease besides asthma (COPD, bronchiectasis, ILD, sarcoidosis, etc).
- Presence of another chronic systemic inflammatory disease (rheumatoid arthritis or other connective-tissue disease, chronic infection such as osteomyelitis, inflammatory bowel disease, chronic active hepatitis, etc). Subjects with osteoarthritis, stable coronary artery disease, hypertension, or diabetes mellitus will not be excluded.
- Presence of malignant neoplasm within the last 3 years (with the exception of non-melanoma skin cancer).
- Clinically significant left or right ventricular dysfunction.
- Severe pulmonary hypertension (high blood pressure).
- Untreated obstructive sleep apnea:
- Subjects with a current diagnosis of sleep apnea not being treated with CPAP or BiPAP will be excluded.
- Subjects with a current diagnosis of sleep apnea being treated adequately (as determined by the investigators) will be included.
- Prader-Willi syndrome
- A known endocrinopathy causing obesity (e.g., Cushing's Syndrome).
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: David Beuther, MD, National Jewish Medical and Research Center faculty
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- NJC HS1963
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .