Phenotyping Mitochondrial and Immune Dysfunction in POTS With Targeted Clinical Intervention.
- Conditions
- Postural Tachycardia Syndrome
- Registration Number
- NCT05409651
- Lead Sponsor
- University of California, San Diego
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria:<br><br> 1. Age: 18-70 years old<br><br> 2. POTS, as defined by the presence of any of the following criteria:<br><br> - For patients age 20 or older, increase in heart rate = 30 bpm within ten<br> minutes of upright posture (tilt test or standing) from a supine position (For<br> patients age 18-19, heart rate increase must be >40 bpm)<br><br> - Associated with related symptoms that are worse with upright posture and that<br> improve with recumbency<br><br> - Chronic symptoms that have lasted for longer than six months<br><br> - In the absence of other disorders, medications, or functional states that are<br> known to predispose to orthostatic tachycardia<br><br> 3. Baseline eating period > 12-hour window<br><br> Exclusion Criteria:<br><br> 4. Taking insulin within the last 6 months.<br><br> 5. Manifest diabetes, defined as HbA1c > 7.0% given a 0.3% margin of error in lab<br> readings, or diagnosis of diabetes.<br><br> 6. Known inflammatory and/or rheumatologic disease.<br><br> 7. Active tobacco abuse or illicit drug use or history of treatment for alcohol abuse.<br><br> 8. Pregnant or breast-feeding women.<br><br> 9. Shift workers with variable (e.g. nocturnal) hours.<br><br> 10. Caregivers for dependents requiring frequent nocturnal care/sleep interruptions.<br><br> 11. Planned travel to a time zone with greater than a 3-hour difference during study<br> period.<br><br> 12. History of a major adverse cardiovascular event within the past 1 year (acute<br> coronary syndrome (ACS), percutaneous coronary intervention, coronary artery bypass<br> graft surgery, hospitalization for congestive heart failure, stroke/transient<br> ischemic attack (TIA)).<br><br> 13. Uncontrolled arrhythmia (i.e. rate-controlled atrial fibrillation/atrial flutter are<br> not exclusion criteria).<br><br> 14. History of thyroid disease requiring dose titration of thyroid replacement<br> medication(s) within the past 3 months (i.e. hypothyroidism on a stable dose of<br> thyroid replacement therapy is not an exclusion).<br><br> 15. History of adrenal disease.<br><br> 16. History of malignancy undergoing active treatment, except non-melanoma skin cancer.<br><br> 17. Known history of type I diabetes.<br><br> 18. History of eating disorder.<br><br> 19. History of cirrhosis.<br><br> 20. History of stage 4 or 5 chronic kidney disease or requiring dialysis.<br><br> 21. History of HIV/AIDS.<br><br> 22. Currently enrolled in a weight-loss or weight-management program.<br><br> 23. On a special or prescribed diet for other reasons (e.g. Celiac disease).<br><br> 24. Currently taking any medication that is meant for, or has known effect on, appetite.<br><br> 25. Any history of surgical intervention for weight management.<br><br> 26. Uncontrolled psychiatric disorder (including history of hospitalization for<br> psychiatric illness).<br><br> 27. A score of >16 on the Epworth Sleepiness Scale (ESS).<br><br> 28. Depression determined by the Beck Depression Inventory (BDI-II) (unless previously<br> diagnosed and well-controlled)<br><br> 29. Failure to use the smartphone app for documentation (defined as <2 meals/day for =3<br> days during baseline).
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Conduct a pilot clinical trial with POTS patients to assess if TRE can improve Quality of Life.
- Secondary Outcome Measures
Name Time Method