Haptoglobin and Iron in Parkinson's Disease

NCT02422992 | Completed DMC

• 1 other identifier: 12A-1330
• Study Type: observational
• Target: 342
• Locations: 1 country
• Sites: 3

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.

Conditions

Parkinson's Disease

Keywords

Iron metabolism; MRI; risk factors; haptoglobin phenotype

Outcome Measures

Primary Outcomes (1)

• Iron metabolism differences between PD patients and controls

  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.

  Up to 7 years

Secondary Outcomes (1)

• Environmental factors affecting PD risk and gene-environment interactions

  recruitment until January 2016

Study Arms (2)

PD

100 PD patients were patients diagnosed with Parkinson's disease

Controls

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

Eligibility Criteria

• Age: 35 Years - 92 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• Volunteers should be of age between 52 and 82 years of age, males of females.

You may not qualify if:

• 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
• Diagnosis of Parkinson's disease (UKBB clinical criteria).
• 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
• presence in the body of a ferro-magnetic metallic foreign object such as, but not limited to:

Sponsors & Collaborators

• Bastyr University: lead
• University of Washington: collaborator

Study Sites (3)

University of California

San Diego, California, 92093, United States

Location

Bastyr University Research Institute

Kenmore, Washington, 98028, United States

Location

University of Washington

Seattle, Washington, 98195, United States

Location

Related Publications (1)

• 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.

  PMID: 17918239 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

We collect serum and plasma samples during the study, that were tested for total serum iron and iron-binding proteins.

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Paola Costa-Mallen, PhD

  Bastyr University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2015
• First Posted: April 22, 2015
• Study Start: February 1, 2013
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: November 29, 2016

Record last verified: 2016-11

Locations

US (3)