N/A
N=110
Mitochondrial Stress, Brain Imaging, and Epigenetics
Mitochondrial Diseases
Bottom Line
View on ClinicalTrials.gov: NCT04831424 ↗Enrolled (actual)
110
Serious AEs
0.0%
Results posted
Apr 2025
Primary outcome: Primary: Average TSST-induced Elevation in Cortisol — 37.44; 33.86; 42.83; 45.42 ng*min/mL
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Trier social stress test (Behavioral)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Columbia University
- Primary completion
- Jun 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Average TSST-induced Elevation in Cortisol |
37.44; 33.86; 42.83; 45.42 | — |
| PRIMARY Average Allostatic Load Index |
9.10; 10.74; 11.31; 12.00 | — |
| SECONDARY Average TSST-induced Elevation in Heart Rate |
14.8; 12.4; 10.9; 12.7 | — |
| SECONDARY Correlation Between Anxiety and Mitochondrial Respiration |
0.10; 0.04; 0.01; 0.22; 0.04; 0.003 | — |
| SECONDARY Average Neuropsychological Function |
0.00; -0.14; -0.58; -0.26 | — |
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.
Eligibility Criteria
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)
Data sourced from ClinicalTrials.gov (NCT04831424). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.