Gastrointestinal Symptoms in Postural Orthostatic Tachycardia Syndrome

NCT03263819 | Completed Results

• 1 other identifier: 170052
• Study Type: observational
• Target: 26
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Postural Tachycardia Syndrome

Keywords

gastrointestinal hormones; Postural Orthostatic Tachycardia Syndrome

Outcome Measures

Primary Outcomes (3)

• 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

  0-120 minutes during intervention

• 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.

  0-120 minutes during intervention

• 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.

  0-120 minutes after the oral glucose ingestion

Secondary Outcomes (1)

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

  0-120 mins

Study Arms (2)

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

Oral glucose tolerance test DIAGNOSTIC_TEST

75 grams of glucose

Healthy controls; POTS: Postural Tachycardia Syndrome

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Related Publications (29)

• 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.

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• 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

  BACKGROUND

• Dysautonomia International: Postural Orthostatic Tachycardia Syndrome [Internet]. [cited 2016 Aug 15]. Available from: http://www.dysautonomiainternational.org/page.php?ID=30

  BACKGROUND

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Biospecimen

Retention: SAMPLES WITH DNA

Whole blood will be retain for DNA extraction.

MeSH Terms

Conditions

Postural Orthostatic Tachycardia Syndrome

Interventions

Glucose Tolerance Test

Condition Hierarchy (Ancestors)

Orthostatic Intolerance; Primary Dysautonomias; Autonomic Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Investigative Techniques

Results Point of Contact

• Title: Dr.Cyndya A. Shibao
• Organization: Vanderbilt University Medical Center

cyndya.shibao@vumc.org

6159364584

Study Officials

• cyndya shibao

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 24, 2017
• First Posted: August 28, 2017
• Study Start: June 20, 2017
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: July 8, 2024
• Results First Posted: July 8, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)