- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT04037410
Environmental Temperature and White Adipose Tissue in Cancer Patients
Effects of Environmental Temperature on White Adipose Tissue Thermogenic Capacity of Cancer Patients
Descripción general del estudio
Estado
Condiciones
Descripción detallada
Obesity is characterized by excessive white adipose tissue (WAT) that increases risk for disease. About 700 million adults are obese worldwide, designating the need of reducing excessive WAT in humans and subsequently the risk for disease. For this reason, previous research focused on the thermogenic capacity of white adipocytes in response to cold exposure. Cold exposure represents a main stimulus for increased thermogenic capacity in human white adipocytes, which may have an impact on body weight loss and subsequently on obesity phenomenon.
In a cohort of 202 cancer patients (male=126), who undertook a Positron Emission Tomography (PET/CT), we retrospectively investigated the association between Tenv and thermogenic capacity of subcutaneous WAT (dorsolumbar region near vertebrae L3 and abdominal region). These patients undertook a PET/CT examination in order to define their disease status. They were given instructions in advance to refrain from smoking, exercise and excessive muscle stressors 24-hour prior to their examination. On the day of the measurements they advised to transport themselves by car to the PET/CT Laboratory between 08:00 am to 12 pm, following at least a 6-hour fasting. Patients were first injected an appropriate dose of 18F-FDG (based on their body weight) and then they were remained in a sitting relaxed position within a quiet room of 22-24°C for 60 minutes. Following this period, patients undertook the PET/CT examination, which included on average eight bed positions, while four minutes scanning per bed position was used.
PET/CT imaging analysis for WAT activity (dorsolumbar region near vertebrae L3 and abdominal region) was performed by two independent trained physicians, using previous methodology.
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Thessaly
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Tríkala, Thessaly, Grecia, 42100
- Petros Dinas
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- Cancer patients who undertook a PET/CT examination independently of their disease status
Exclusion Criteria:
- Examinations prior to 2016
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Assessment of thermogenic capacity of white adipocytes
Periodo de tiempo: The SUV of white adipocytes for each patient was measured once via the PET/CT software between 10-30 May 2019.
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Thermogenic capacity of white adipocytes was measured via Positron Emission Tomography/computed tomography (PET/CT) device, unit of measurement: Standardized Uptake Value (SUV)
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The SUV of white adipocytes for each patient was measured once via the PET/CT software between 10-30 May 2019.
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Environmental temperature
Periodo de tiempo: The daily environmental temperature was obtained from Weather Underground (www.wunderground.com) on the 10th May 2019
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The daily environmental temperature was obtained in degrees Celsius for the period 1-1-2016 to 30-4-2019.
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The daily environmental temperature was obtained from Weather Underground (www.wunderground.com) on the 10th May 2019
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
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 (Actual)
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
Otros números de identificación del estudio
- 2. Tenv & cancer patient
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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. .
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