The Influence of Epigenetic Modifications and Post-Exertional Malaise in People With Myalgic Encephalomyelitis/Chronic Fatigue Syndrome

Status: Completed
Location: See location...
Intervention Type: Other, Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: t
View:

• diagnosis of ME/CFS established by a MD experienced in the field of internal medicine and ME/CFS - according to the published international criteria developed by the Canadian Consensus Criteria (CCC);

• age between 18 and 70 years old;

• body mass index (BMI) below 30 (no obesity).

Locations
Other Locations
Belgium
UZ Brussel
Brussels
Time Frame
Start Date: 2021-04-01
Completion Date: 2023-04-30
Participants
Target number of participants: 105
Treatments
Experimental: ME/CFS Exercise
Patients undergoing the physical stress test (aerobic power index)
Experimental: Patients Stress
Patients undergoing the mental stress task (MIST)
Active_comparator: Healthy Exercise
Healthy controls undergoing the physical stress test (aerobic power index)
Active_comparator: Healthy Stress
Healthy controls undergoing the mental stress task (MIST)
Related Therapeutic Areas
Sponsors
Leads: Vrije Universiteit Brussel

This content was sourced from clinicaltrials.gov