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Epigenetics of Post-exertional Malaise in Patients With ME/CFS

NCT04378634 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 105

Last updated 2023-11-07

No results posted yet for this study

Summary

Exploring epigenetic mechanisms of Myalgic Encephalomyelitis / Chronic Fatigue Syndrome (ME/CFS) is crucial to understand the mechanisms underlying its pathophysiology. Three potential candidates have been selected (BDNF, COMT, and HDAC genes). DNA methylation in the promoter regions of those genes will be explored.

The investigators designed a randomised controlled trial and will enrol 70 patients with ME/CFS and 35 age-, sex-, and BMI-matched healthy controls. Both groups will be randomised in 2 groups and receive either one session of aerobic exercise or a validated test designed to trigger mental stress and mental fatigue. The primary aim is to assess genetic and epigenetic mechanisms of BDNF, COMT and HDAC genes in response to exercise and the stress task.

Conditions

  • Fatigue Syndrome, Chronic

Interventions

BEHAVIORAL

Exercise

Sub-maximal exercise test

OTHER

Mental Stress Test

Computerised mental arithmetic challenges and social evaluative threat tasks

Sponsors & Collaborators

  • Vrije Universiteit Brussel

    lead OTHER

Principal Investigators

  • Jo Nijs, PhD · Vrije Universiteit Brussel

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-04-01
Primary Completion
2023-04-30
Completion
2023-04-30

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04378634 on ClinicalTrials.gov