- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT03394898
Evaluation of Body Mass Index and Eating Behaviour Changes in Female Patients With Fibromyalgia Under Medical Treatment
Prospective, Observational Study of Evaluation of Body Mass Index and Eating Behaviour Changes in Female Patients With Fibromyalgia Under Medical Treatment
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
The female patients with fibromyalgia under medical treatment say that body mass index and eating behaviour changes,for this reason, this relationship will be investigated in this study.
Demographic data (sex, age, education level, occupation) of patients with fibromyalgia diagnosis will be questioned and height lengths will be measured. The group of medications (serotonin and norepinephrine reuptake inhibitor or GABAergic drugs) that begins with the diagnosis of the disease fibromyalgia will be recorded.
All patients will be assessed when diagnosed, followed by 2nd week and then 4nd week.
In each follow-up, the patients' weights will be measured again (the body mass index will be calculated from the measured value).
In each follow-up, the effect of fibromyalgia on the daily life of the patients will be questioned with Fibromyalgia Impact Questionnaire (FIQ). The FIQ was developed from information gathered from patient reports, functional status instruments, and clinical observations. This instrument measures physical functioning, work status (missed days of work and job difficulty), depression, anxiety, morning tiredness, pain, stiffness, fatigue, and well-being over the past week.
In each follow-up, patients' eating behaviour will be questioned with Three Factor Eating Questionnaire. The 18-item Three-Factor Eating Questionnaire is a scale that measures three domains of eating behavior: cognitive restraint , uncontrolled eating and emotional eating.
In each follow-up, the right calf circumference of the patients will be measured in centimeters with a tape measure .
Tipo de estudio
Inscripción (Anticipado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Ömer Necati Develioglu, M.D.
- Número de teléfono: +90 212 945 30 00
- Correo electrónico: taksimetikkurul@gmail.com
Ubicaciones de estudio
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Istanbul, Pavo, 34255
- Reclutamiento
- Gaziosmanpasa Taksim Research and Education Hospital
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Contacto:
- Ömer Necati Develioğlu, MD
- Número de teléfono: +90 212 945 30 00
- Correo electrónico: taksimetikkurul@gmail.com
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- Female subjects between the ages of 18-40
- Subjects, who met the 2013 American College of Rheumatology (ACR) criteria for Fibromyalgia
Exclusion Criteria:
- History of eating disorders such as anorexia nervosa, bulimia nevroza
- History of hypothyroidism or hyperthyroidism
- Pregnant or breast feeding
- History of central or peripheral nervous system disorders
- History of infectious, chronic inflammatory disease, malignant tumors
- Subjects with active psychiatric illness or who use psychiatric medication
- Uncooperative subject
- History of cardiac pathology such as heart failure, coronary artery disease
- History of diabetes, chronic renal insufficiency, chronic liver failure
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 |
---|---|---|
eating behaviour
Periodo de tiempo: 7 days
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Patients' eating behaviour will be questioned with Three Factor Eating Questionnaire.
The 18-item Three-Factor Eating Questionnaire is a scale that measures three domains of eating behavior: cognitive restraint , uncontrolled eating and emotional eating.
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7 days
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
activities of daily living
Periodo de tiempo: 7 days
|
The effect of fibromyalgia on the daily life of the patients will be questioned with Fibromyalgia Impact Questionnaire (FIQ).
The FIQ was developed from information gathered from patient reports, functional status instruments, and clinical observations.
This instrument measures physical functioning, work status (missed days of work and job difficulty), depression, anxiety, morning tiredness, pain, stiffness, fatigue, and well-being over the past week.
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7 days
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calf circumference
Periodo de tiempo: 1 day
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The right calf circumference of the patients will be measured in centimeters with a tape measure .
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1 day
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body mass index
Periodo de tiempo: 1 day
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The patients' weights and heights will be measured and the body mass index will be calculated from the measured values.
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1 day
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: alper MENGİ, M.D., Gaziosmanpasa Taksim Training and Research Hospital
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
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
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 27.12.2017/108
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
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.
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