Altman Clinical and Translational Research Institute
La Jolla, California, 92093, United States
NCT Number: NCT05409651
The mechanisms underlying POTS are not well understood. Though heterogeneous in nature, patients often present with symptoms that include fatigue, orthostatic lightheadedness and tachycardia, "brain fog", shortness of breath, and sleep disruption. The central mediator that links observations in disease entities similar to POTS is energy use and balance driven by mitochondrial health. Mitochondrial dysfunction (i.e. respiration defects, reactive oxygen species (ROS) generation, and structural abnormalities) are hallmarks of currently defined syndromes that resemble POTS symptomatology. Many patients with POTS have underlying immune system dysfunction, which, when treated, may improve the patient's overall health. Though autoimmunity has been demonstrated in POTS, overall immune dysregulation may be broader and include immune cell exhaustion and persistent inflammatory cytokine responses. Immune dysfunction including cellular exhaustion and persistent inflammation has been linked to mitochondrial function. Therefore, we hypothesize that a unifying feature of POTS results from latent or continued mitochondrial/immune dysfunction which then impacts multi-organ energy imbalance and immune homeostasis. Understanding and targeting mitochondria utilizing established, novel, and directed approaches including time-restricted eating (TRE) will help to unravel common etiologies and help us to better diagnose, manage, and treat POTS.
This study is active but is not currently recruiting participants.
18 year–70 year
All sexes
Interventional
Not applicable
La Jolla, California, 92093, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants in this arm will adhere to a daily, consistent 8-10-hr eating window for the course of the study.
Other names: TRE
Time frame: Change from Baseline quality of life questionnaire at 14 weeks
Intervention with TRE will significantly improve quality of life (QOL). We will conduct a 12-week intervention with POTS patients to assess the impact of TRE on QOL (primary endpoint) utilizing the quality of life questionnaire SF-36..
Time frame: Change from Baseline mitochondrial function at 14 weeks
Mitochondrial damage is a common feature of POTS regardless of triggers, comorbidities, and heterogeneity. We will test this hypothesis by assessing blood-based markers of mitochondrial function in patients with POTS and compare to banked healthy controls.
Time frame: Change from Baseline immune response at 14 weeks
Immune homeostasis is disrupted in POTS leading to aberrant persistent cytokine responses and immune cell (T, B, NK cell) exhaustion. We will test immune exhaustion and persistent inflammation through flow cytometry of peripheral blood cells from patients with POTS as well as perform serum multiplex ELISA of cytokines and compare them with banked controls.
University of California, San Diego
Other
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