Determination of Metabolomic Profile Differences in Possible Sarcopenia Accompanying Fibromyalgia… (NCT07381348) | Clinical Trial Compass
CompletedNot Applicable
Determination of Metabolomic Profile Differences in Possible Sarcopenia Accompanying Fibromyalgia Syndrome in Women
Turkey (Türkiye)66 participantsStarted 2022-06-01
Plain-language summary
The goal of this observational study is to determine the serum metabolome profile differences in the presence of possible sarcopenia in patients with fibromyalgia and to compare them with healthy individuals. In this way, it is aimed to contribute to the knowledge about the pathophysiology, diagnosis and treatment of these diseases.The main questions it aims to answer are:
* Is there a difference in blood metabolite levels and metabolic pathways in fibromyalgia syndrome and possible sarcopenia accompanying fibromyalgia syndrome?
* Based on these identified differences, can biomarkers be determined for these diseases?
Who can participate
Age range
18 Years – 60 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Being between 18-60 years old
. Being diagnosed with Fibromyalgia according to ACR 2016 diagnostic criteria
. Having agreed to participate in the study
. Healthy controls
. Being a woman
Exclusion criteria
. Those who cannot take command due to cognitive dysfunction
. Pregnancy
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Comparison of serum metabolite concentrations between groups. Plasma samples were collected from all participants. Samples were centrifuged at 1500 rpm for 10 minutes and stored at -80 degrees to be used in metabolome analysis.
Timeframe: through study completion, an average of 1 year