Haptoglobin and Iron in Parkinson's Disease

Parkinson's Disease Clinical Trial

— HPPD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02422992
• Other study ID #: 12A-1330
• Status: Completed
• Phase: N/A
• First received: April 15, 2015
• Last updated: November 28, 2016
• Start date: February 2013
• Est. completion date: June 2016

Study information

• Verified date: November 2016
• Source: Bastyr University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 342
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 35 Years to 92 Years

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Locations

Country	Name	City	State
United States	Bastyr University Research Institute	Kenmore	Washington
United States	University of California	San Diego	California
United States	University of Washington	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Bastyr University	University of Washington

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Environmental factors affecting PD risk and gene-environment interactions	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.	recruitment until January 2016	No