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Active Not RecruitingNCT05409651

Phenotyping Mitochondrial and Immune Dysfunction in POTS With Targeted Clinical Intervention.

Status
Active Not Recruiting
Phase
N/A
Study type
Interventional
Enrollment
25 (actual)
Sponsor
University of California, San Diego · Academic / Other
Sex
All
Age
18 Years – 70 Years
Healthy volunteers
Not accepted

Summary

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALTime restricted eatingParticipants in this arm will adhere to a daily, consistent 8-10-hr eating window for the course of the study.

Timeline

Start date
2022-07-01
Primary completion
2024-05-10
Completion
2025-06-01
First posted
2022-06-08
Last updated
2024-08-20

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT05409651. Inclusion in this directory is not an endorsement.