- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02422992
Haptoglobin and Iron in Parkinson's Disease (HPPD)
Haptoglobin Phenotype and Smoking: Effects on Iron Levels in Parkinson's Disease
Study Overview
Status
Conditions
Detailed Description
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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California
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San Diego, California, United States, 92093
- University of California
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Washington
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Kenmore, Washington, United States, 98028
- Bastyr University Research Institute
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Seattle, Washington, United States, 98195
- University of Washington
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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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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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Iron metabolism differences between PD patients and controls
Time Frame: 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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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Environmental factors affecting PD risk and gene-environment interactions
Time Frame: 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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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Paola Costa-Mallen, PhD, Bastyr University
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 12A-1330
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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