Clinical trial NCT02422992: Haptoglobin and Iron in Parkinson's Disease
Official title: Haptoglobin Phenotype and Smoking: Effects on Iron Levels in Parkinson's Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parkinson's Disease
Keywords: Iron metabolism
MRI
risk factors
haptoglobin phenotype
Lead sponsor: Bastyr University
Sponsor class: OTHER
Collaborators: name: University of Washington
First posted: 2015-04-22
Enrollment: 342
Sex: ALL
Minimum age (years): 35
Maximum age (years): 92
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
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

Brief summary: This is a case/control epidemiology study to identify what are the iron-metabolism abnormalities in Parkinson's disease (PD) patients, and risk factors relevant to PD predisposition.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Iron metabolism differences between PD patients and controls
timeFrame: Up to 7 years
Secondary outcomes:
measure: Environmental factors affecting PD risk and gene-environment interactions
timeFrame: recruitment until January 2016
Other outcomes:
Locations:
city: San Diego
country: United States
facility: University of California
state: California
city: Kenmore
country: United States
facility: Bastyr University Research Institute
state: Washington
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: Bastyr University
name: Paola Costa-Mallen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Costa-Mallen P, Checkoway H, Zabeti A, Edenfield MJ, Swanson PD, Longstreth WT Jr, Franklin GM, Smith-Weller T, Sadrzadeh SM. The functional polymorphism of the hemoglobin-binding protein haptoglobin influences susceptibility to idiopathic Parkinson's disease. Am J Med Genet B Neuropsychiatr Genet. 2008 Mar 5;147B(2):216-22. doi: 10.1002/ajmg.b.30593.