Haptoglobin and Iron in Parkinson's Disease (HPPD)

Bastyr University

Status: Completed

Conditions: Parkinson's Disease

Study type: Observational

Funder types: Other

Identifiers

NCT02422992

12A-1330

Details and patient eligibility

About

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.

Full 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.

Enrollment: 342 patients

Sex: All

Ages: 35 to 92 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

342 participants in 2 patient groups

PD

Description:

100 PD patients were patients diagnosed with Parkinson's disease

Controls

Description:

242 Controls were subjects free of neurodegenerative diseases, matched by age and gender to the PD patients