Gastrointestinal Symptoms in Postural Orthostatic Tachycardia Syndrome (POTS-GUT)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03263819|
Recruitment Status : Recruiting
First Posted : August 28, 2017
Last Update Posted : August 29, 2017
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.
|Condition or disease|
|Postural Tachycardia Syndrome|
Show Detailed Description
|Study Type :||Observational|
|Estimated Enrollment :||48 participants|
|Official Title:||POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME AND GASTROINTESTINAL SYMPTOMS: Contribution of Gastrointestinal Peptides|
|Actual Study Start Date :||June 20, 2017|
|Estimated Primary Completion Date :||June 30, 2018|
|Estimated Study Completion Date :||June 30, 2018|
patients with postural orthostatic tachycardia syndrome diagnosis.
Patients with Postural orthostatic tachycardia syndrome who has peripheral neuropathy
Defined as subjects without any significant past medical history.
Patients with complete pure autonomic failure.
- Gastrointestinal hormones plasma levels after oral glucose tolerance test [ Time Frame: 0-120 minutes. ]The plasma levels of GI peptides (GLP-1, GLP-2, PPY, glucagon, C-peptide, insulin) and their pattern of secretion after ingestion of 75 g glucose.
- Gastric emptying after oral glucose [ Time Frame: 0-120 minutes. ]Gastric emptying time will be measured by acetaminophen absorption test after ingestion of 75 grams glucose.
- Gastrointestinal symptoms [ Time Frame: 0-120 minutes ]The gastrointestinal symptoms will be evaluated by questionnaire after ingestion of 75 grams glucose.
- POTS related symptoms [ Time Frame: 0-120 minutes. ]Symptoms related to postural orthostatic tachycardia symptoms will be evaluated by specific questionnaire after ingestion of 75 grams glucose.
Biospecimen Retention: Samples With DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03263819
|Contact: Cyndya Shibao, MDfirstname.lastname@example.org|
|Contact: shahram Ejtemaeimehr, PharmD, PhDemail@example.com|
|United States, Tennessee|
|Vanderbilt University Medical Center||Recruiting|
|Nashville, Tennessee, United States, 37232|
|Contact: Cyndya Shibao, MD, MSCI firstname.lastname@example.org|
|Contact: Cyndya A Shibao, MD, MSCI 6155120956 email@example.com|
|Principal Investigator: Cyndya Shibao, MD, MSCI|
|Sub-Investigator: Shahram Ejtemaeimehr, PharmD, PhD|
|Sub-Investigator: Emily Garland, PhD|
|Sub-Investigator: Amanda Peltier, MD|
|Sub-Investigator: Robyn tamboli, MD|