Measurement of Biomarkers in Samples Collected in a Coenzyme Q10 Treatment Trial in Gulf War Illness and Control Subjects
Technical Report,30 Sep 2018,29 Sep 2019
South Florida VA Foundation for Research and Education Inc. Miami United States
Pagination or Media Count:
The current project is a partnership of a clinician, Dr. Klimas, and a laboratory scientist, Dr. Fletcher, to examine the usefulness of biomarkers in the treatment of GWI, and predicting the subgroup most responsive to an antioxidant intervention, ubiquinol. It is hypothesized that CoQ10 will favorably affect the biomarker signature found in GWI patients. Specifically, we seek to perform biomarker analysis before and after two, four, and six months of therapy with blood collections from subjects in the clinical trial. Laboratory assessments consists of plasma cytokines, natural killer cell function, plasma levels of neuropeptide Y, immune-phenotyping studies using flow cytometry, and mitochondrial function This data will then be used to correlate these biomarkers with symptom clusters, illness severity and their usefulness in predicting responders to the intervention. Recruitment is ongoing in the Phase III placebo control treatment trial of CoQ10, which is sponsored by the VA. In this collaborative DoD study, we are assessing the biomarkers pre and post-treatment from the plasma, serum, and PBMCs obtained from 71 participants to date. As this is a blind, randomized trial, we cannot compare the participants treated with CoQ10 200mg to the matched GWI participant placebo group until the end of the study, though we have a growing data set of baseline data for the cohorts. Our timeline is tied to the ongoing clinical trial, which just entered the final year, with an extension granted by VA CSRD. We have worked out the logistics of obtaining and processing samples from the 4 sites and linking data to the clinical assessment dataset. We have adjusted our anticipated spending to reserve funding for an anticipated continuation year, based on the timeline of the VA based clinical trial.
- Medicine and Medical Research