Haptoglobin and Iron in Parkinson's Dis… | Clinical Trial

Key information

Conditions

Parkinson's Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Synucleinopathies

Age range

35 year–92 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of California, San Diego, California, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Iron metabolism differences between PD patients and controls

Time frame: Up to 7 years

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.

Secondary outcomes

Environmental factors affecting PD risk and gene-environment interactions

Time frame: recruitment until January 2016

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.

Sponsors and collaborators

Lead sponsor

Bastyr University

Other

Collaborators

University of Washington

Registry information

Official study title

Haptoglobin Phenotype and Smoking: Effects on Iron Levels in Parkinson's Disease

Acronym: HPPD

Important dates

Study start: 2013
Primary completion: 2016
Study completion: 2016
First posted: Apr 22, 2015
Registry last updated: Nov 29, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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