# Metabolic Biomarkers for Fibromyalgia

> **NIH NIH R01** · UNIVERSITY OF IOWA · 2021 · $297,371

## Abstract

Project Summary
Fibromyalgia (FM) is a complex condition characterized by widespread pain and fatigue that is associated with
sleep dysfunction and reduced function that affects 2-4% of the population (Heidari et al., 2017). Current 2016
diagnostic criteria are by symptomology only, as there are no validated chronic pain biomarkers to assist with
diagnosis, or treatment evaluation endpoints (Wolfe et al., 2016). Diagnosing FM often takes years with
patients seeing multiple physicians, which delays treatment (Choy, 2010). This delayed diagnosis and
treatment initiation would be dramatically reduced with the identification of FM biomarkers. The long-term goal
of this line of research is to identify unique biomarkers for FM to improve the diagnosis and/or develop
therapeutic targets for individuals with widespread pain. Using a semi-targeted metabolomics approach, our
preliminary data from women with FM (n=59), compared to healthy controls (n=38), show 18 potential
candidates that differ significantly between cohorts with several metabolites showing good-excellent sensitivity
(>90%) and specificity (>90%). The primary goal of this proposed research is to assess and validate
candidate metabolic biomarkers in a new, larger cohort of individuals and compared to other chronic pain
populations. The proposed study will use a multi-site, cross-sectional design to identify and characterize
metabolic biomarkers, biosignatures, and their associations with multiple symptomology domains to address
the following two specific aims: Aim 1: We will characterize diagnostic test metrics for candidate biomarkers
using receiver operating curves (ROCs), i.e. sensitivity and specificity, and test-retest reliability, to correctly
identify individuals with FM from healthy controls and other chronic pain conditions: osteoarthritis, carpal tunnel
syndrome, and rheumatoid arthritis. Aim 2: We will determine associations between putative metabolic
biomarkers and multiple self-reported symptom domains in those with FM: a) pain; b) fatigue; c) sleep; d)
physical function; e) psychological factors, and f) disease impact/disability. We have identified several
promising metabolic biomarkers that may serve as diagnostic or within-disease phenotype identifiers. Once
completed, we will examine potential mechanistic and therapeutic targets for the candidate biomarkers in
subsequent studies. These novel studies have the potential to identify a diagnostic, and potentially a
therapeutic, biomarker of FM associated with cell metabolism. To accomplish this study, we have developed a
strong multidisciplinary and multi-site team, leveraging blood samples and phenotype data collected as part of
an on-going funded study, as well as additional data collection for repeatability analyses. The study team has
the necessary expertise in human, basic science and metabolomics investigations to successfully complete
these aims.

## Key facts

- **NIH application ID:** 10248414
- **Project number:** 5R01AR077418-02
- **Recipient organization:** UNIVERSITY OF IOWA
- **Principal Investigator:** Laura A Frey Law
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $297,371
- **Award type:** 5
- **Project period:** 2020-09-01 → 2025-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10248414

## Citation

> US National Institutes of Health, RePORTER application 10248414, Metabolic Biomarkers for Fibromyalgia (5R01AR077418-02). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10248414. Licensed CC0.

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