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CompletedNCT03263819POTS-GUTUpdated Jul 8, 2024Results posted

Gastrointestinal Symptoms in Postural Orthostatic Tachycardia Syndrome

An observational study in Postural Tachycardia Syndrome, sponsored by Vanderbilt University Medical Center. Completed at 1 site in United States. Open to female participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2024-07-08.

Sponsored by Vanderbilt University Medical Center · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
26
Ages
18 Years to 60 Years
Sex
Female
01

Study 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.

Read the detailed description

Postural Tachycardia Syndrome (POTS) is a disabling condition that mostly affects young women in their reproductive age. It is characterized by chronic (>6 months) orthostatic intolerance symptoms (palpitation, lightheadedness, blurred vision and mental clouding) triggered by assuming an upright posture and that improved upon recumbency. These symptoms are associated with a rapid increase in heart rate (≥30 bpm) that occur within 10 minutes upon standing. POTS is estimated to affect up to 3 million persons in the United States and is considered a syndrome rather than a single disease.

The pathophysiology of POTS is complex, and are related to abnormal cardiovascular autonomic adaptation to postural changes. Under normal conditions, the assumption of upright posture does not result in major changes in blood pressure due to the integration of complex autonomic, circulatory and neurohumoral responses. Upright posture-induced a fluid shift of approximately 700 mL of blood from the upper thorax to the splanchnic circulation and lower extremities, which result in decrease in venous return to the heart, ventricular filling, and stroke volume. These changes cause unloading of the arterial baroreceptors and increase in sympathetic activity, vasoconstriction and restoration of stroke volume and cardiac output.

In POTS patients, multiple mechanisms have been proposed to explain the exaggerated increase in heart rate. The orthostatic tachycardia could be a compensatory phenomenon to hypovolemia, impaired sympathetic-mediated vasoconstriction or increased vascular compliance. The later could induce an exaggerated fluid shift upon standing from thorax to lower body. Depending on the mechanism involved different POTS phenotype has been described: (i) hypovolemic POTS; (ii) neuropathic POTS; and (iii) POTS associated with Ehlers-Danlos and joint hypermobility syndrome (EDS/JHS). Of note, there is overlapping in the pathophysiology of POTS with patients having more than one etiology.

In addition to the cardiovascular symptoms, patients with POTS experience significant gastrointestinal symptoms namely nausea, bloating, diarrhea or even severe constipation. Furthermore, large meals or high carbohydrate meals exacerbates the feelings of palpitations, weakness, and fatigue in these patients.

Multiple studies have reported the presence of alterations in the gastrointestinal motility. Pooled data from 352 patients recruited from 6 different studies, showed 21-80% prevalence of nausea, vomiting, and abdominal pain. In four of these studies that measured gastric motility, they found that 43% prevalence of rapid gastric emptying and 20% prevalence of delayed gastric emptying. Furthermore, Al-Shekhlee et al. reported a high prevalence of impaired sudomotor function in the POTS patients who reported GI symptoms suggesting that abnormal post-ganglionic sympathetic function could play a role in the pathophysiology of these GI abnormalities.

We previously defined a subgroup of POTS patients in whom we detected a partial peripheral autonomic neuropathy primarily affecting lower extremities (neuropathic POTS). These subjects had decreased norepinephrine spillover in response to sympathetic activation and abnormal sweat volumes and prolonged latency detected by quantitative sudomotor axon reflex (QSART). Recently, Gibbons and Freeman (2013) strengthen the definition by providing histological evidence of neuronal damage with the inclusion of skin biopsies with specific staining for autonomic dense fiber and sensitivity assessment.

In Neuropathic POTS there is evidence of impaired vasomotor tone in different specific vascular bed, particularly the splanchnic circulation. Tani et al. reported reduced splanchnic vascular resistance and increase in resting mesenteric blood flow providing evidence of splanchnic denervation.

In summary, there is evidence of post-ganglionic sympathetic denervation is a subset of patients with POTS. The most current definition are based on the presence of abnormal sudomotor and sensitivity assessment.

The sympathetic nervous system (SNS) provide innervation to the enteric ganglia, the circular muscles of sphincters, and the mucosa of the stomach and intestines. The SNS also negatively regulate the motor and secretory functions of the gastrointestinal (GI) tract. Browning and Travagli (2014) reported that the absence of sympathetic inhibitory innervation causes excessive and uncoordinated activity in the GI tract. Indicating that a preserved ANS (autonomic nervous system) regulation of the GI tract is crucial for the maintenance of normal GI motility.

In addition to regulating the motor function, the SNS and parasympathetic nervous system (PNS) regulate the postprandial GI peptides secretion by enteroendocrine cells (EEC). EECs are the first line components of the Brain-Gut axis. Multiple peptides, such as incretins (GLP-1, GLP-2, GIP), and PYY (peptide YY) are important for the maintenance of glucose homeostasis. They are secreted by a different type of EEC in the GI tract. Prior to their absorption, nutrients in the GI lumen are important stimuli for peptide secretion in the ileum in rats, pigs , and humans. These peptides are secreted before the bulk of ingested meal reaches to the ileum, suggesting the presence of a neuronal/endocrine pathway in GI tract.

In summary, the SNS through innervation the gut smooth muscle; ENS (enteric nervous system) and EECs negatively regulate the GI motor function and incretins secretion which impact glucose homeostasis.

Evidence from animal models showed that when rats underwent removal of the superior autonomic mesenteric ganglia that contains mostly SNS neurons and were challenged with an oral glucose gavage; plasma insulin and C-peptide secretion were increased compared with controls (non-ganglionectomised rats). Furthermore, glucose levels were much lower in the ganglionectomised rats suggesting that the SNS splanchnic innervation plays a critical role in the maintenance of glucose homeostasis. The increased secretion of insulin and C-peptide levels in this model could be explained by an increase in incretin hormonal release. Additional studies using isolated guineas pig ileum (in vitro model) showed that GLP-1 secretion is inhibited by SNS nerve stimulation which is mediated by α-adrenergic receptors.

In summary, in the absence of sympathetic tone on ENS and EECs the incretins secretion increases which may cause low levels of plasma glucose.

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.

The glucose homeostasis will be evaluated by a modified oral glucose tolerance test (OGTT). In addition, we will assess GI symptoms and hemodynamics before and after oral glucose (at minute 0, 30, 60, 90, and 120). The plasma levels of GI peptides (GLP-1, GLP-2, PYY, glucagon, C-peptide, insulin) will be measured in different time points after oral glucose. Gastric emptying will be evaluated by acetaminophen absorption test (AAT). The LPS (lipopolysaccharide), LBP (lipopolysaccharid-binding protein), sCD14, and I-FABP (faty acid-binding protein) as GUT cells damage markers will be measured at baseline. The following technics will be used in this study:

  1. Oral glucose tolerance test (OGTT): In the case of OGTT, subjects will be given a ready-to-use test solution (TRUTOL® 75, Thermo Scientific, USA) containing 75 g glucose dissolved in 300 mL water, immediately after fasting blood sampling. They will be instructed to drink the test solution within 5 mins. Blood samples will be drawn at 5, 10, 15, 30, 60, 90, and 120 minutes after drinking the ready-to-use test solution. Gastric emptying will be measured by acetaminophen absorption test.
  2. Acetaminophen absorption test (AAT): Acetaminophen (20 mg/kg) will be given to patients. Serum acetaminophen will be determined by fluorescence polarization immunoassay. This assay uses a six-point calibration curve, and the detection limit is 4 µmol/L. The coefficient of variation is less than 5%. Estimation of the rate of gastric emptying was based on serum concentrations of acetaminophen in the blood samples collected. An algorithm that transforms serum concentrations of paracetamol into estimates of gastric emptying was applied. This algorithm adjusts for first-pass metabolism, unequal distribution and individual rate of elimination, and provides estimates for the percentage of meal emptied from the stomach as a function of time.
  3. Gastrointestinal symptoms scoring: The 2-page questionnaire is based on elements from a questionnaire that have been validated with some modifications. The questionnaire contains 17 questions on the frequency of GI symptoms that have been troublesome in the preceding 6 months. The frequency of each symptom is rated on seven-point Likert scale from no discomfort to very severe discomfort.
  4. Hemodynamic symptoms scoring: Hemodynamic symptoms will be measured by using the Vanderbilt POTS Symptom Score. The patients will be asked to rate the severity of 9 symptoms on a 0-10 scale (with 0 reflecting an absence of symptoms). The sum of the scores at each time point will be used as a measure of symptom burden. The 9 symptoms are: mental clouding, blurred vision, shortness of breath, rapid heartbeat, tremulousness, chest discomfort, headache, lightheadedness, and nausea. This symptom score has been previously used by our center, and the symptoms were chosen as they reflect common complaints of patients with POTS.
  5. Glucose and insulin levels: Glucose levels will be measured with a glucose analyzer (YSI Life Sciences, Yellow Springs, OH).
  6. GI peptides measurements: The plasma designated for GLP-1 measurement will be supplemented with aprotinin (1,000 kallikrein inactivation unit (KIU)/ml) and dipeptidyl peptidase-4 inhibitor (20 μl/ml plasma; Millipore, St. Charles, MO). Plasma insulin, c-peptide, glucagon, GIP, active GLP-1 (7-37 and 7-36 amide), peptide YY, pancreatic polypeptide, and leptin were measured by multiplex immunoassays (Luminex, Millipore).
02

Conditions studied

  • Postural Tachycardia Syndrome

Keywords

  • gastrointestinal hormones
  • Postural Orthostatic Tachycardia Syndrome
03

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
Female
Sampling method
Non-probability sample

Study population

The participants with POTS and "complete autonomic failure" will be recruited from patients referred to the Vanderbilt University Autonomic Dysfunction Center. Additional patients will be recruited from the POTS registry in ResearchMatch, and information about the study will be posted on websites associated with POTS support groups. Healthy volunteers will be recruited from a population of previous participants in autonomic studies, through the ResearchMatch.org database, Subject Locator, and through advertising and emails around the Vanderbilt community.

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

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.

04

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
26 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • POTS: Postural Tachycardia Syndrome

    patients with postural orthostatic tachycardia syndrome diagnosis.

    Diagnostic Test: Oral glucose tolerance test

  • Healthy controls

    Patients with Postural orthostatic tachycardia syndrome who has peripheral neuropathy

    Diagnostic Test: Oral glucose tolerance test

Interventions

  • Diagnostic testOral glucose tolerance test

    75 grams of glucose

05

What researchers measure

Primary outcomes

  1. C-peptide Levels After Oral Glucose Tolerance Test

    The plasma levels of GIP (Glucose-dependent insulinotropic polypeptide) ,GLP-1, C-peptide, insulin) and their pattern of secretion after ingestion of 75 g glucose. C peptide measured in pg/ml

    Time frame: 0-120 minutes during intervention

  2. Insulin Levels After Oral Glucose Tolerance Test

    The plasma levels of GIP (Glucose-dependent insulinotropic polypeptide) ,GLP-1, C-peptide, insulin) and their pattern of secretion after ingestion of 75 g glucose.

    Time frame: 0-120 minutes during intervention

  3. GIP and GLP-1 Levels After Oral Glucose Tolerance Test

    The plasma levels of GIP (Glucose-dependent insulinotropic polypeptide) ,GLP-1, C-peptide, insulin) and their pattern of secretion after ingestion of 75 g glucose.

    Time frame: 0-120 minutes after the oral glucose ingestion

Secondary outcomes

  1. Changes in Systemic Hemodynamics After 75-gr Oral Glucose and During Orthostasis

    The percent change (before-after 75 gram of oral glucose) of standing heart rate and stroke volume (SV).

    Time frame: 0-120 mins

06

Results

Posted Jul 8, 2024

Participant flow

The study started June 20, 2017. Participants were enrolled in Vanderbilt University medical center

Participant flow — Overall Study
MilestonePOTS SubjectsHealthy Controls
Started1313
Completed1213
Not completed10
Withdrew: 1 subject was excluded from analysis because she was using glp-1 agonist for weight contro10

Outcome measures

PrimaryC-peptide Levels After Oral Glucose Tolerance Test

The plasma levels of GIP (Glucose-dependent insulinotropic polypeptide) ,GLP-1, C-peptide, insulin) and their pattern of secretion after ingestion of 75 g glucose. C peptide measured in pg/ml

Time frame:
0-120 minutes during intervention
Reported as:
Mean · pg/mL
C-peptide Levels After Oral Glucose Tolerance Test
pg/mLC Peptide Level in POTS PatientsC Peptide Level in Healthy Controls
C-peptide Levels After Oral Glucose Tolerance Test40.6 ± 9.523.2 ± 4.8
PrimaryInsulin Levels After Oral Glucose Tolerance Test

The plasma levels of GIP (Glucose-dependent insulinotropic polypeptide) ,GLP-1, C-peptide, insulin) and their pattern of secretion after ingestion of 75 g glucose.

Time frame:
0-120 minutes during intervention
Reported as:
Mean · uU/mL
Insulin Levels After Oral Glucose Tolerance Test
uU/mLInsulin Levels in POTS PatientsInsulin Levels in Healthy Controls
Insulin Levels After Oral Glucose Tolerance Test85.2 ± 44.048.79 ± 13.69
PrimaryGIP and GLP-1 Levels After Oral Glucose Tolerance Test

The plasma levels of GIP (Glucose-dependent insulinotropic polypeptide) ,GLP-1, C-peptide, insulin) and their pattern of secretion after ingestion of 75 g glucose.

Time frame:
0-120 minutes after the oral glucose ingestion
Reported as:
Mean · pmol/L
GIP and GLP-1 Levels After Oral Glucose Tolerance Test
pmol/LPOTS PatientsHealthy Controls
GIP secretion at 120 mins75.72 ± 41.7742.74 ± 9.6
GLP-1 secretion at 30 mins66.0 ± 23.053.9 ± 18.3
SecondaryChanges in Systemic Hemodynamics After 75-gr Oral Glucose and During Orthostasis

The percent change (before-after 75 gram of oral glucose) of standing heart rate and stroke volume (SV).

Time frame:
0-120 mins
Reported as:
Mean · Percent change
Changes in Systemic Hemodynamics After 75-gr Oral Glucose and During Orthostasis
Percent changePOTSHealthy Controls
% change in standing HR21.2 ± 11.96.0 ± 19.9
percent change in standing stroke volume-10.3 ± 11.903.3 ± 13.7

Adverse events

Collected over At the time of study visit, up to 120 minutes. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
POTS0/13 (0%)0/13 (0%)0/13 (0%)
Healthy Controls0/13 (0%)0/13 (0%)0/13 (0%)

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)POTSHealthy ControlsTotal
<=18 years000
Between 18 and 65 years121325
>=65 years000
Age, Continuous
Age, Continuous(years)POTSHealthy ControlsTotal
Mean36.8 ± 11.729.9 ± 7.833.3 ± 9.7
Sex: Female, Male
Sex: Female, Male(Participants)POTSHealthy ControlsTotal
Female121325
Male000
Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)POTSHealthy ControlsTotal
Count of participants——0
Height
Height(cm)POTSHealthy ControlsTotal
Mean168.4 ± 5.8168.5 ± 5.3168.4 ± 5.5
BMI
BMI(kg/m^2)POTSHealthy ControlsTotal
Mean23.4 ± 4.122.5 ± 3.222.9 ± 3.6
Fasting Glucose
Fasting Glucose(mg/dl)POTSHealthy ControlsTotal
Mean90.2 ± 21.280.4 ± 12.685.3 ± 16.9
Insulin
Insulin(mlU/ml)POTSHealthy ControlsTotal
Mean8.4 ± 2.87.5 ± 3.87.95 ± 3.3

5 further baseline measures are reported on the registry.

07

Study locations

1 site
  • Vanderbilt University Medical Center
    Nashville, Tennessee 37232, United States
08

References and documents

Publications

  • Agarwal AK, Garg R, Ritch A, Sarkar P. Postural orthostatic tachycardia syndrome. Postgrad Med J. 2007 Jul;83(981):478-80. doi: 10.1136/pgmj.2006.055046. PubMed 17621618 ↗
  • Postural Tachycardia Syndrome Information Page: National Institute of Neurological Disorders and Stroke (NINDS) [Internet]. [cited 2016 Aug 15]. Available from: http://www.ninds.nih.gov/disorders/postural_tachycardia_syndrome/postural_tachycardia_syndrome.htm
  • Dysautonomia International: Postural Orthostatic Tachycardia Syndrome [Internet]. [cited 2016 Aug 15]. Available from: http://www.dysautonomiainternational.org/page.php?ID=30
  • Zhang Q, Chen X, Li J, Du J. Clinical features of hyperadrenergic postural tachycardia syndrome in children. Pediatr Int. 2014 Dec;56(6):813-816. doi: 10.1111/ped.12392. Epub 2014 Oct 15. PubMed 24862636 ↗
  • Mathias CJ, Low DA, Iodice V, Owens AP, Kirbis M, Grahame R. Postural tachycardia syndrome--current experience and concepts. Nat Rev Neurol. 2011 Dec 6;8(1):22-34. doi: 10.1038/nrneurol.2011.187. PubMed 22143364 ↗
  • Lawal A, Barboi A, Krasnow A, Hellman R, Jaradeh S, Massey BT. Rapid gastric emptying is more common than gastroparesis in patients with autonomic dysfunction. Am J Gastroenterol. 2007 Mar;102(3):618-23. doi: 10.1111/j.1572-0241.2006.00946.x. PubMed 17100966 ↗
  • Antiel RM, Risma JM, Grothe RM, Brands CK, Fischer PR. Orthostatic intolerance and gastrointestinal motility in adolescents with nausea and abdominal pain. J Pediatr Gastroenterol Nutr. 2008 Mar;46(3):285-8. doi: 10.1097/MPG.0b013e318145a70c. PubMed 18376245 ↗
  • Wang LB, Culbertson CJ, Deb A, Morgenshtern K, Huang H, Hohler AD. Gastrointestinal dysfunction in postural tachycardia syndrome. J Neurol Sci. 2015 Dec 15;359(1-2):193-6. doi: 10.1016/j.jns.2015.10.052. Epub 2015 Oct 30. PubMed 26671111 ↗
  • Loavenbruck A, Iturrino J, Singer W, Sletten DM, Low PA, Zinsmeister AR, Bharucha AE. Disturbances of gastrointestinal transit and autonomic functions in postural orthostatic tachycardia syndrome. Neurogastroenterol Motil. 2015 Jan;27(1):92-8. doi: 10.1111/nmo.12480. Epub 2014 Dec 6. PubMed 25483980 ↗
  • Park KJ, Singer W, Sletten DM, Low PA, Bharucha AE. Gastric emptying in postural tachycardia syndrome: a preliminary report. Clin Auton Res. 2013 Aug;23(4):163-7. doi: 10.1007/s10286-013-0193-y. Epub 2013 May 25. PubMed 23708963 ↗
  • Al-Shekhlee A, Lindenberg JR, Hachwi RN, Chelimsky TC. The value of autonomic testing in postural tachycardia syndrome. Clin Auton Res. 2005 Jun;15(3):219-22. doi: 10.1007/s10286-005-0282-7. PubMed 15944872 ↗
  • Lomax AE, Sharkey KA, Furness JB. The participation of the sympathetic innervation of the gastrointestinal tract in disease states. Neurogastroenterol Motil. 2010 Jan;22(1):7-18. doi: 10.1111/j.1365-2982.2009.01381.x. Epub 2009 Aug 14. PubMed 19686308 ↗
  • Browning KN, Travagli RA. Central nervous system control of gastrointestinal motility and secretion and modulation of gastrointestinal functions. Compr Physiol. 2014 Oct;4(4):1339-68. doi: 10.1002/cphy.c130055. PubMed 25428846 ↗
  • Mundinger TO, Cummings DE, Taborsky GJ Jr. Direct stimulation of ghrelin secretion by sympathetic nerves. Endocrinology. 2006 Jun;147(6):2893-901. doi: 10.1210/en.2005-1182. Epub 2006 Mar 9. PubMed 16527847 ↗
  • Moran GW, Leslie FC, Levison SE, Worthington J, McLaughlin JT. Enteroendocrine cells: neglected players in gastrointestinal disorders? Therap Adv Gastroenterol. 2008 Jul;1(1):51-60. doi: 10.1177/1756283X08093943. Erratum In: Therap Adv Gastroenterol. 2008 Sep;1(2):144. Worthington, J [added]. PubMed 21180514 ↗
  • Roberge JN, Brubaker PL. Regulation of intestinal proglucagon-derived peptide secretion by glucose-dependent insulinotropic peptide in a novel enteroendocrine loop. Endocrinology. 1993 Jul;133(1):233-40. doi: 10.1210/endo.133.1.8319572. PubMed 8319572 ↗
  • Knapper JM, Heath A, Fletcher JM, Morgan LM, Marks V. GIP and GLP-1(7-36)amide secretion in response to intraduodenal infusions of nutrients in pigs. Comp Biochem Physiol C Pharmacol Toxicol Endocrinol. 1995 Jul;111(3):445-50. doi: 10.1016/0742-8413(95)00046-1. PubMed 8564784 ↗
  • Layer P, Holst JJ, Grandt D, Goebell H. Ileal release of glucagon-like peptide-1 (GLP-1). Association with inhibition of gastric acid secretion in humans. Dig Dis Sci. 1995 May;40(5):1074-82. doi: 10.1007/BF02064202. PubMed 7729267 ↗
  • Blat S, Guerin S, Chauvin A, Seve B, Morgan L, Cuber JC, Malbert CH. The vagus is inhibitory of the late postprandial insulin secretion in conscious pigs. Auton Neurosci. 2002 Oct 31;101(1-2):68-77. doi: 10.1016/s1566-0702(02)00184-4. PubMed 12462361 ↗
  • Orskov C, Rabenhoj L, Wettergren A, Kofod H, Holst JJ. Tissue and plasma concentrations of amidated and glycine-extended glucagon-like peptide I in humans. Diabetes. 1994 Apr;43(4):535-9. doi: 10.2337/diab.43.4.535. PubMed 8138058 ↗
  • Kumakura A, Shikuma J, Ogihara N, Eiki J, Kanazawa M, Notoya Y, Kikuchi M, Odawara M. Effects of celiac superior mesenteric ganglionectomy on glucose homeostasis and hormonal changes during oral glucose tolerance testing in rats. Endocr J. 2013;60(4):525-31. Epub 2013 Jan 11. PubMed 23318598 ↗
  • Hansen L, Lampert S, Mineo H, Holst JJ. Neural regulation of glucagon-like peptide-1 secretion in pigs. Am J Physiol Endocrinol Metab. 2004 Nov;287(5):E939-47. doi: 10.1152/ajpendo.00197.2004. PubMed 15475512 ↗
  • Jacob G, Costa F, Shannon JR, Robertson RM, Wathen M, Stein M, Biaggioni I, Ertl A, Black B, Robertson D. The neuropathic postural tachycardia syndrome. N Engl J Med. 2000 Oct 5;343(14):1008-14. doi: 10.1056/NEJM200010053431404. PubMed 11018167 ↗
  • Schondorf R, Low PA. Idiopathic postural orthostatic tachycardia syndrome: an attenuated form of acute pandysautonomia? Neurology. 1993 Jan;43(1):132-7. doi: 10.1212/wnl.43.1_part_1.132. PubMed 8423877 ↗
  • Gibbons CH, Bonyhay I, Benson A, Wang N, Freeman R. Structural and functional small fiber abnormalities in the neuropathic postural tachycardia syndrome. PLoS One. 2013 Dec 27;8(12):e84716. doi: 10.1371/journal.pone.0084716. eCollection 2013. PubMed 24386408 ↗
  • Fujimura J, Camilleri M, Low PA, Novak V, Novak P, Opfer-Gehrking TL. Effect of perturbations and a meal on superior mesenteric artery flow in patients with orthostatic hypotension. J Auton Nerv Syst. 1997 Dec 3;67(1-2):15-23. doi: 10.1016/s0165-1838(97)00087-8. PubMed 9470140 ↗
  • Chaudhuri KR, Thomaides T, Mathias CJ. Abnormality of superior mesenteric artery blood flow responses in human sympathetic failure. J Physiol. 1992 Nov;457:477-89. doi: 10.1113/jphysiol.1992.sp019388. PubMed 1297840 ↗
  • Tani H, Singer W, McPhee BR, Opfer-Gehrking TL, Haruma K, Kajiyama G, Low PA. Splanchnic-mesenteric capacitance bed in the postural tachycardia syndrome (POTS). Auton Neurosci. 2000 Dec 28;86(1-2):107-13. doi: 10.1016/S1566-0702(00)00205-8. PubMed 11269915 ↗
  • Revicki DA, Wood M, Wiklund I, Crawley J. Reliability and validity of the Gastrointestinal Symptom Rating Scale in patients with gastroesophageal reflux disease. Qual Life Res. 1998 Jan;7(1):75-83. doi: 10.1023/a:1008841022998. PubMed 9481153 ↗

Study documents

  • Protocol and statistical analysis plan · Jun 2, 2021

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

09

Registry details

Key details

Study ID
NCT03263819
Lead sponsor
Vanderbilt University Medical Center
Responsible party
Cyndya Shibao, MD (Assistant Professor, Vanderbilt University Medical Center) — Principal investigator
First posted
Aug 28, 2017
Start date
Jun 20, 2017
Primary completion
Dec 31, 2020
Completion
Dec 31, 2020
Results posted
Jul 8, 2024
Last update
Jul 8, 2024

Study contacts

cyndya shibao
principal investigator · Vanderbilt University Medical Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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