Genetics of Fibromyalgia

NCT ID: NCT00071162

Last Updated: 2009-04-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

560 participants

Study Classification

OBSERVATIONAL

Study Start Date

1999-09-30

Brief Summary

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The Fibromyalgia Family Study identifies and collects blood samples from families with two or more members affected with Fibromyalgia Syndrome (FMS). The primary goal of the study is to identify genes that predispose people to FMS and/or symptoms related to FMS; identifying these genes may lead to a better understanding of the disease and more effective treatments.

Detailed Description

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FMS predominantly affects women and is characterized by chronic widespread musculoskeletal pain, fatigue, sleep disturbance, and multiple tender points on physical examination. The pathophysiological mechanisms underlying FMS are not clearly understood, but neuroendocrine factors seem to be of major importance. Studies of familial association suggest that genetic factors play a role in FMS. This study will establish patterns of genetic linkage in families with FMS.

Participating family members will undergo a brief physical exam (including tender point exam), donate a blood sample, and complete a detailed questionnaire that includes experience with pain, fatigue, depression, bowel symptoms, headache, anxiety, and physical limitations. Measurements of serum serotonin and related compounds will also be obtained. To detect genetic factors, a genome-wide linkage scan using 405 microsatellite markers will be performed.

Conditions

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Fibromyalgia Irritable Bowel Syndrome Chronic Fatigue Syndrome Depression

Study Design

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Observational Model Type

FAMILY_BASED

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Diagnosed with fibromyalgia according to the criteria of the American College of Rheumatology
* Have at least one living family member who has also been diagnosed with fibromyalgia
* No other major rheumatological disease
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

NIH

Sponsor Role lead

Responsible Party

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Case Western Reserve University

Principal Investigators

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Sudha Iyengar, PhD

Role: STUDY_CHAIR

Case Western Reserve University

Locations

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University of Illinois at Peoria

Peoria, Illinois, United States

Site Status

University of Cincinnati

Cincinnati, Ohio, United States

Site Status

Case Western Reserve University

Cleveland, Ohio, United States

Site Status

University of Texas Health Sciences Center

San Antonio, Texas, United States

Site Status

Countries

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United States

References

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Yunus MB, Khan MA, Rawlings KK, Green JR, Olson JM, Shah S. Genetic linkage analysis of multicase families with fibromyalgia syndrome. J Rheumatol. 1999 Feb;26(2):408-12.

Reference Type BACKGROUND
PMID: 9972977 (View on PubMed)

Other Identifiers

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NIAMS-100

Identifier Type: -

Identifier Source: org_study_id

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