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

NCT05409651 | Active Not Recruiting

• 1 other identifier: 802200
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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

Postural Tachycardia Syndrome

Keywords

Time-Restricted Eating; Intermittent fasting; POTS; Postural Tachycardia Syndrome

Outcome Measures

Primary Outcomes (1)

• Conduct a pilot clinical trial with POTS patients to assess if TRE can improve Quality of Life.

  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..

  Change from Baseline quality of life questionnaire at 14 weeks

Other Outcomes (2)

• Exploratory Outcome: Characterize mitochondrial function in POTS patients

  Change from Baseline mitochondrial function at 14 weeks

• Exploratory Outcome: Assess whether POTS patients demonstrate persistent inflammatory responses and immune cell exhaustion

  Change from Baseline immune response at 14 weeks

Study Arms (1)

Time restricted eating

EXPERIMENTAL

Everyone in this arm will implement a daily 8-10-hour window within which they must consume their calories. They will also be required to log their caloric intake through the use of a smartphone app.

Behavioral: Time restricted eating

Interventions

Time restricted eating BEHAVIORAL

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

Also known as: TRE

Time restricted eating

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: 18-70 years old
• POTS, as defined by the presence of any of the following criteria:
• For patients age 20 or older, increase in heart rate ≥ 30 bpm within ten minutes of upright posture (tilt test or standing) from a supine position (For patients age 18-19, heart rate increase must be \>40 bpm)
• Associated with related symptoms that are worse with upright posture and that improve with recumbency
• Chronic symptoms that have lasted for longer than six months
• In the absence of other disorders, medications, or functional states that are known to predispose to orthostatic tachycardia
• Baseline eating period \> 12-hour window

You may not qualify if:

• Taking insulin within the last 6 months.
• Manifest diabetes, defined as HbA1c \> 7.0% given a 0.3% margin of error in lab readings, or diagnosis of diabetes.
• Known inflammatory and/or rheumatologic disease.
• Active tobacco abuse or illicit drug use or history of treatment for alcohol abuse.
• Pregnant or breast-feeding women.
• Shift workers with variable (e.g. nocturnal) hours.
• Caregivers for dependents requiring frequent nocturnal care/sleep interruptions.
• Planned travel to a time zone with greater than a 3-hour difference during study period.
• History of a major adverse cardiovascular event within the past 1 year (acute coronary syndrome (ACS), percutaneous coronary intervention, coronary artery bypass graft surgery, hospitalization for congestive heart failure, stroke/transient ischemic attack (TIA)).
• History of adrenal disease.
• History of malignancy undergoing active treatment, except non-melanoma skin cancer.
• Known history of type I diabetes.
• History of eating disorder.
• History of cirrhosis.
• History of stage 4 or 5 chronic kidney disease or requiring dialysis.

Sponsors & Collaborators

• University of California, San Diego: lead
• Dysautonomia International: collaborator

Study Sites (1)

Altman Clinical and Translational Research Institute

La Jolla, California, 92093, United States

Location

MeSH Terms

Conditions

Postural Orthostatic Tachycardia Syndrome; Intermittent Fasting

Condition Hierarchy (Ancestors)

Orthostatic Intolerance; Primary Dysautonomias; Autonomic Nervous System Diseases; Nervous System Diseases; Fasting; Feeding Behavior; Behavior

Study Officials

• Pam Taub, MD

  Professor of Medicine

  PRINCIPAL INVESTIGATOR

• Taylor Doherty, MD

  Professor of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: May 16, 2022
• First Posted: June 8, 2022
• Study Start: July 1, 2022
• Primary Completion: May 10, 2024
• Study Completion: June 1, 2025
• Last Updated: August 20, 2024

Record last verified: 2024-08

Locations

US (1)