Haptoglobin and Iron in Parkinson's Disease

Completed

• Conditions: Parkinson's Disease

• Registration Number: NCT02422992
• Lead Sponsor: Bastyr University

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.

Study Timeline

• Study Start: 2013-02
• Study First Submitted: 2015-04-15
• Study First Submitted QC: 2015-04-17
• Study First Posted: 2015-04-22
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-28
• Last Update Posted: 2016-11-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 342

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Iron metabolism differences between PD patients and controls	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 Outcome Measures

Name	Time	Method
Environmental factors affecting PD risk and gene-environment interactions	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.

Trial Locations

Locations (3)

University of California; 🇺🇸 San Diego, California, United States

Bastyr University Research Institute; 🇺🇸 Kenmore, Washington, United States

University of Washington; 🇺🇸 Seattle, Washington, United States