NCT06725199

Brief Summary

Evaluation of sera of fibromyalgia patients in terms of energy metabolism function and possible alterations in metabolism predisposing to various degenerative/proliferative diseases.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

December 4, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 10, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2025

Completed
Last Updated

December 10, 2024

Status Verified

December 1, 2024

Enrollment Period

3 months

First QC Date

December 4, 2024

Last Update Submit

December 7, 2024

Conditions

Patients with Clinical Complaints of Fibromyalgia Among the Patients Applying to the Outpatient ClinicFibromyalgia Syndrome

Keywords

fibromyalgiametabolomics profiling

Outcome Measures

Primary Outcomes (1)

  • Metabolomic Profiling

    Biochemical enzymes will be measured by NMR techniques.

    September 2024- February 2025

Study Arms (2)

Healthy group

Blood and urine samples taken from completely healthy individuals will be examined.

Fibromyalgia group

Blood and urine samples taken from individuals diagnosed with fibromyalgia will be examined

Eligibility Criteria

Age18 Years - 65 Years
Sexall(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients aged 18-65 years Patients with clinical complaints of fibromyalgia and control group (healthy)

You may qualify if:

  • patients aged 18-65 years Patients with clinical complaints of fibromyalgia

You may not qualify if:

  • Viral or bacterial infections, Diabetes mellitus, Hypertension, Chronic renal failure, Hypo-hyperthyroidism) Patients taking antidepressants or medication, Smokers and alcohol users, Patients with rheumatic arthritis and systemic lupus erythematosus were excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Beykent

Istanbul, Istanbul, 34000, Turkey (Türkiye)

Location

Related Publications (1)

  • Malatji BG, Meyer H, Mason S, Engelke UFH, Wevers RA, van Reenen M, Reinecke CJ. A diagnostic biomarker profile for fibromyalgia syndrome based on an NMR metabolomics study of selected patients and controls. BMC Neurol. 2017 May 11;17(1):88. doi: 10.1186/s12883-017-0863-9.

    PMID: 28490352BACKGROUND

MeSH Terms

Conditions

Fibromyalgia

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
OTHER
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
assistant professor

Study Record Dates

First Submitted

December 4, 2024

First Posted

December 10, 2024

Study Start

September 1, 2024

Primary Completion

December 1, 2024

Study Completion

February 1, 2025

Last Updated

December 10, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will share

In this prospective two-group study, metabolite identification will be performed according to the peaks obtained in the NMR spectrum in 50 patients with clinically diagnosed fibromyalgia and 50 healthy volunteers and it is aimed to perform the quantitation of these metabolites with the software to be provided for the study. Measurement of citrate, isocitrate, alpha ketoglutarate, succinyl CoA, fumarate, malate, glutamate, G-6 PD, phosphogluconate, glyceraldehyde 3 P and oxaloacetate levels by NMR technique. Measurement of citrate, isocitrate, alpha ketoglutarate, succinyl CoA, fumarate, malate, glutamate, G-6 PD, phosphogluconate, glyceraldehyde 3 P and oxaloacetate levels by NMR technique not routine for this disease but will be studied in this group for scientific research purposes

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

TU(1)