CompletedNot Applicable

Mitochondrial Stress, Brain Imaging, and Epigenetics

United States110 participantsStarted 2018-06-12

Plain-language summary

The MiSBIE study collects biological, behavioral, psychosocial, neuropsychological, and brain imaging data in participants with either: normal mitochondrial function, individuals with the m.3243A\>G mitochondrial DNA (mtDNA) mutation, and individuals a single large-scale mtDNA deletion. These defects induce mitochondrial allostatic load (MAL). The 2-day protocol, plus home-based data collection, will provide a comprehensive assessment of the multi-systemic dysregulation associated with MAL or mitochondrial dysfunction, and the link to physical and mental health-related symptoms. Aim 1: Determine the influence of MAL on systemic AL biomarkers. Aim 2: Establish the influence of MAL on stress reactivity profiles. Aim 3. Examine the association between MAL and psychological functioning.

Who can participate

Age range18 Years – 60 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Men and women patients between 18 and 55 years of age * Willing to provide saliva samples and have venous catheter installed for blood collection during the hospital visit * Willing to provide informed consent and capacity to consent * Use of effective method of birth control for women of childbearing capacity * English Speaking Exclusion Criteria: * Individuals with cognitive deficit incapable of providing informed consent will not be included * Symptoms of flu or other seasonal infection four weeks preceding hospital visit * Raynaud's syndrome (Raynaud phenomenon) * Involvement in any therapeutic trials listed on clinicaltrials.gov, including exercise * Metal inside or outside the body or claustrophobia prohibitive to MRI testing * Diagnosed with mitochondrial disease m.3243A\>G, or large scale mtDNA deletion (for healthy controls)

What they're measuring

Average TSST-induced Elevation in Cortisol

Timeframe: Day 1 post challenge (approximately 2 hours)

Average Allostatic Load Index

Timeframe: Blood collected on Day 1

Trial details

NCT IDNCT04831424

SponsorColumbia University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-06-30

Results submitted2025-02-06