- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02422992
Haptoglobin and Iron in Parkinson's Disease (HPPD)
Haptoglobin Phenotype and Smoking: Effects on Iron Levels in Parkinson's Disease
Descripción general del estudio
Estado
Condiciones
Descripción detallada
A total of 342 participants, 100 PD patients and 242 age- and gender matched controls, were included in the study. All study participants were seen for one study visit in the morning at one of two Bastyr University Clinics in the Seattle area. Study participants were fasting at the time of the visit. During the study visit, participants donated a blood sample for the blood tests and complete an epidemiology questionnaire.
A subset of 51 of the study participant who were seen for the visit at Bastyr University, underwent brain scan and Magnetic Resonance Imaging (MRI), at the University of Washington Department of Radiology. The MRI part of the study aims at estimating brain iron levels.
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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California
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San Diego, California, Estados Unidos, 92093
- University of California
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Washington
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Kenmore, Washington, Estados Unidos, 98028
- Bastyr University Research Institute
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Seattle, Washington, Estados Unidos, 98195
- University of Washington
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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
Parkinson's disease patients will be included in the study if they received a diagnosis of Parkinson's disease that meets the United Kingdom Brain Bank (UKBB) clinical criteria of Parkinson's disease diagnosis.
Control participants will be included in the study if free of neurodegenerative diseases.
A subset of the study participants (60 total) receive Magnetic Resonance Imaging to estimate brain iron
Descripción
Inclusion Criteria for the Controls, for the blood draw and epidemiology visit:
- Volunteers should be of age between 52 and 82 years of age, males of females.
Exclusion Criteria for the Controls:
- presence of a neurodegenerative disease,
- presence of active cancer under treatment,
- HIV sero-positivity, Hepatitis B, C, of A sero-positivity
- rheumatoid arthritis
- recent blood donation (less than three months before the visit).
- fever at the time of the visit
Inclusion Criteria for the Parkinson's disease patients:
Diagnosis of Parkinson's disease (UKBB clinical criteria).
Exclusion criteria for the Parkinson's disease patients, for the blood draw and epidemiology visit:
- Presence of other neurodegenerative diseases, apart for Parkinson's disease
- two or more family members with Parkinson's disease
- presence of active cancer under treatment
- HIV sero-positivity, Hepatitis B, C, of A sero-positivity
- rheumatoid arthritis
- recent blood donation (less than three months before the visit).
- fever at the time of the visit
Exclusion criteria for the Magnetic Resonance Imaging:
- presence in the body of a ferro-magnetic metallic foreign object such as, but not limited to:
- a cardiac pacemaker
- aneurism clip
- neuro-stimulator
- surgical clip
- artificial limb or joint
- orthopedic items, such as screws, nails, pins, rods,
- any metallic foreign body from a previous injury, bullets, shrapnels, metal slivers.
- exclusion criteria for MRI is also the presence of claustrophobia
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
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PD
100 PD patients were patients diagnosed with Parkinson's disease
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Controls
242 Controls were subjects free of neurodegenerative diseases, matched by age and gender to the PD patients
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Iron metabolism differences between PD patients and controls
Periodo de tiempo: Up to 7 years
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Iron metabolism will be measured by testing for serum iron and iron-binding proteins, and by estimating brain iron by MRI.
Serum iron parameters that will be measured include total serum iron, iron-binding proteins such as transferrin and ferritin, and tests related to iron metabolism: transferrin % saturation, unsaturated iron binding capacity, soluble transferrin receptor, complete blood count, hemoglobin, uric acid, haptoglobin, haptoglobin phenotype.
Differences in serum iron parameters, and brain iron levels, between PD patients and controls will be calculated.
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Up to 7 years
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Environmental factors affecting PD risk and gene-environment interactions
Periodo de tiempo: recruitment until January 2016
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Questionnaire data will be analyzed to identify risk factors for PD by comparing lifestyle and dietary patterns from questionnaire between PD cases and controls.
Interaction between haptoglobin phenotype and tobacco smoking on PD risk will be calculated, as well as interaction between haptoglobin phenotype and environmental factors such as tobacco smoking and diet on serum iron and brain iron levels.
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recruitment until January 2016
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Paola Costa-Mallen, PhD, Bastyr University
Publicaciones y enlaces útiles
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 (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 12A-1330
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