N/A
N=26
Gastrointestinal Symptoms in Postural Orthostatic Tachycardia Syndrome
Postural Tachycardia Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT03263819 ↗Enrolled (actual)
26
Serious AEs
0.0%
Results posted
Jul 2024
Primary outcome: Primary: C-peptide Levels After Oral Glucose Tolerance Test — 40.6; 23.2 pg/mL
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Oral glucose tolerance test (Diagnostic_test)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Vanderbilt University Medical Center
- Primary completion
- Dec 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY C-peptide Levels After Oral Glucose Tolerance Test |
40.6; 23.2 | — |
| PRIMARY Insulin Levels After Oral Glucose Tolerance Test |
85.2; 48.79 | — |
| PRIMARY GIP and GLP-1 Levels After Oral Glucose Tolerance Test |
75.72; 42.74; 66.0; 53.9 | — |
| SECONDARY Changes in Systemic Hemodynamics After 75-gr Oral Glucose and During Orthostasis |
21.2; 6.0; -10.3; 3.3 | — |
Summary
Patients with POTS experience significant gastrointestinal symptoms. Current evidence suggesting that abnormal post-ganglionic sympathetic function could play a role in the pathophysiology of these GI abnormalities. Sympathetic fiber regulate motor and the postprandial GI peptides secretion.
The focus of the present proposal is to determine glucose homeostasis, GI motility, and their association with GI and cardiovascular symptoms in POTS patients versus healthy controls. Furthermore, we will determine differences in these outcomes in POTS patients with and without evidence of postganglionic sympathetic fiber neuropathy.
As a long-term goal, this study can lead us to understand the pathophysiology of common co-morbidities in patients with POTS to provide new treatment approaches and prevention strategies.
Eligibility Criteria
Inclusion Criteria
- 18-60 years old
- Postural Tachycardia Syndrome: Heart rate increase >30 bpm from supine within 10 min of standing, in the absence of orthostatic hypotension (>20/10 mmHg fall in blood pressure), with chronic symptoms (> 6 months), and in the absence of other acute cause of orthostatic tachycardia.
- Able and willing to provide informed consent
- Female premenopausal subjects must utilize adequate birth control and willingness to undergo serum beta-hCG (human chorionic gonadotropin) testing
Exclusion Criteria
- Use of acetaminophen or acetaminophen-related drugs (over-the-counter) in the 24 hours prior to the study.
- Hypertension (>150 mmHg systolic and >100 mmHg diastolic) based on history or findings on screening.
- Orthostatic hypotension (consistent decrease in BP >20/10 mmHg with 10 min stand)
- Pregnancy
- History of type 1 or type 2 diabetes mellitus
- Cardiovascular disease, such as myocardial infarction within 6 months, angina pectoris, significant arrhythmia (sinus tachycardia is not excluded), deep vein thrombosis, pulmonary embolism
- History of serious neurologic disease
- Impaired hepatic function (aspartate amino transaminase and/or alanine amino transaminase >1.5 x upper limit of normal range)
- Impaired renal function (serum creatinine >1.5 mg/dL)
- Hematocrit <28%
- Any underlying or acute disease requiring regular medication that could possibly pose a threat to the subject or make implementation of the protocol or interpretation of the study results difficult
- Inability to comply with the protocol
Healthy control subjects
Defined as subjects without any significant past medical history, non-smokers, and on no chronic medications at the time of the study. Healthy control subjects will be age- and BMI-matched to the POTS patients.
Positive control
Patients with complete autonomic neuropathy (pure autonomic failure) will be enrolled as positive control. This condition is defined as complete autonomic failure based on AFT (autonomic function test) and norepinephrine plasma levels less than 100 pg/ml.
Data sourced from ClinicalTrials.gov (NCT03263819). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.