Postural Tachycardia SyndromeNCT05409651
Phenotyping Mitochondrial and Immune Dysfunction in POTS With Targeted Clinical Intervention.
A study testing Time restricted eating in people with Postural Tachycardia Syndrome, run by University of California, San Diego at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Postural Tachycardia Syndrome
- What is being tested?
- Time restricted eating
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2022to Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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)).
- Uncontrolled arrhythmia (i.e. rate-controlled atrial fibrillation/atrial flutter are not exclusion criteria).
- History of thyroid disease requiring dose titration of thyroid replacement medication(s) within the past 3 months (i.e. hypothyroidism on a stable dose of thyroid replacement therapy is not an exclusion).
- 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.
- History of HIV/AIDS.
- Currently enrolled in a weight-loss or weight-management program.
- On a special or prescribed diet for other reasons (e.g. Celiac disease).
- Currently taking any medication that is meant for, or has known effect on, appetite.
- Any history of surgical intervention for weight management.
- Uncontrolled psychiatric disorder (including history of hospitalization for psychiatric illness).
- A score of >16 on the Epworth Sleepiness Scale (ESS).
- Depression determined by the Beck Depression Inventory (BDI-II) (unless previously diagnosed and well-controlled)
- Failure to use the smartphone app for documentation (defined as <2 meals/day for ≥3 days during baseline).
Trial locations and contacts
1 site in 1 country.
United States1 site
Altman Clinical and Translational Research Institute
La Jolla, California, 92093
About this study
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
- Being tested
- Time restricted eating
- Keywords
- Time-Restricted Eating, Intermittent fasting, POTS, Postural Tachycardia Syndrome
- Medical subject headings
- Postural Orthostatic Tachycardia Syndrome, Intermittent Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Time restricted eatingBehavioural
Also called TRE
Participants in this arm will adhere to a daily, consistent 8-10-hr eating window for the course of the study.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Time restricted eating |
What is being measured
The primary outcome is the main question the study is designed to answer.
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..
Measured: Change from Baseline quality of life questionnaire at 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2022
- Study start1 Jul 2022
- Primary completion10 May 2024
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postural Tachycardia SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- Dysautonomia International
- Responsible party
- Principal investigator, Pam Taub, MD, University of California, San Diego
- Investigators
- Pam Taub, MD, Principal investigator, Professor of MedicineTaylor Doherty, MD, Principal investigator, Professor of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05409651
- Sponsor's protocol ID
- 802200
- Status last verified
- Aug 2024
- First submitted
- 16 May 2022
- Last updated
- 20 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phenotyping Mitochondrial and Immune Dysfunction in POTS With Targeted Clinical Intervention.
- ClinicalTrials.gov ID
- NCT05409651
- Acronym / sponsor ID
- 802200
- Conditions
- Postural Tachycardia Syndrome
- Keywords
- Time-Restricted Eating, Intermittent fasting, POTS, Postural Tachycardia Syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- Dysautonomia International
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 10 May 2024 (actual)
- Study completion
- Jun 2025 (estimated)
- First posted
- 8 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Time restricted eating | Experimental | Behavioral: Time restricted eatingEveryone 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age: 18-70 years old
- POTS, as defined by the presence of any of the following criteria:
- Baseline eating period > 12-hour window
Key exclusion criteria (26 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Time restricted eatingAlso: TREParticipants in this arm will adhere to a daily, consistent 8-10-hr eating window for the course of the study. | Behavioural | Time restricted eating |
Primary outcome
Conduct a pilot clinical trial with POTS patients to assess if TRE can improve Quality of Life.
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..
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pam Taub, MD principal investigator
Professor of Medicine
Taylor Doherty, MD principal investigator
Professor of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Time restricted eating in people with Postural Tachycardia Syndrome, run by University of California, San Diego at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Conduct a pilot clinical trial with POTS patients to assess if TRE can improve Quality of Life. (time frame: Change from Baseline quality of life questionnaire at 14 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2024; AzTrials last refreshed its copy on 31 Oct 2026.