Idiopathic Gastroparesis Registry Using a Predominant-Symptom Classification
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|ClinicalTrials.gov Identifier: NCT01173484|
Recruitment Status : Terminated (Principal investigator has left the Institution)
First Posted : August 2, 2010
Last Update Posted : April 10, 2017
|Condition or disease|
"Idiopathic gastroparesis" is a poor term to describe this very heterogeneous syndrome. Pathophysiology may not be "idiopathic," but merely unidentifiable with conventional methods suggested for gastroparesis. The diagnosis of "gastroparesis" suggests that delayed gastric emptying is the underlying cause of symptoms, but this description fails to explain the variable presentation. There are fundamental differences in pathophysiology, clinical presentation, severity, and future prognosis among patients with idiopathic gastroparesis. Understanding these differences is necessary in order to provide cost-effective treatment in these patients.
We believe our clinical classification for gastroparesis is a clinical useful tool in the management of patients with idiopathic gastroparesis to predict clinical severity, treatment response, and future prognosis. Patients with vomiting-predominant gastroparesis will be more likely to have an underlying cause, such as viral infection or impaired glucose tolerance with vagal neuropathy. Their symptoms will likely be persistent. Patients with dyspepsia-predominant gastroparesis mimic those with functional dyspepsia and are unlikely to have complications such as weight loss, and dehydration. The necessity of enteric feeding in these patients is also unlikely. Prokinetics may help since delayed gastric emptying may contribute to epigastric pain or postprandial distress. Finding and treating small intestinal bacterial overgrowth as well as suggesting lifestyle and dietary modifications may be helpful. Patients with regurgitation-predominant gastroparesis may benefit most by improving their delayed gastric emptying. Their gastroparesis may cause reflux-like symptoms, especially at night.
|Study Type :||Observational|
|Actual Enrollment :||15 participants|
|Official Title:||Idiopathic Gastroparesis Registry to Define Severity, Treatment Response, and Prognosis Using a Predominant-Symptom Classification|
|Study Start Date :||June 2010|
|Primary Completion Date :||August 2011|
|Study Completion Date :||August 2011|
Vomiting-predominant idiopathic gastroparesis
Vomiting with retching and nausea are the most bothersome symptoms
Dyspepsia-predominant idiopathic gastroparesis
Unpleasant or troublesome sensation (discomfort or pain) centered in the upper abdomen is the most bothersome symptom; this sensation may be characterized by or associated with upper abdominal fullness, fullness after small meals, bloating, or nausea
Regurgitation-predominant idiopathic gastroparesis
Effortless regurgitation of acid or undigested food or heartburn is the most bothersome symptom
- Incidence of poor outcome [ Time Frame: 3 years ]
Compare the incidence of any one of the following indicators of poor outcome between subjects with vomiting-predominant, dyspepsia-predominant, and regurgitation-predominant idiopathic gastroparesis:
i) Developing new weight loss of >10% due to gastroparesis compare to weight at study baseline ii) Gastric failure (severe symptoms requiring G or J tube or TPN) iii) Death
- Clinical severity [ Time Frame: 1 year ]Compare the prevalence of the pre-defined indicators of clinical severity between subjects with vomiting-predominant, dyspepsia-predominant, and regurgitation-predominant at study baseline.
- Incidence of treatment success [ Time Frame: 3 years ]Compare the incidence of pre-defined indicators of treatment success between the predominant-symptom subgroups.
- Potential etiology of "idiopathic" gastroparesis [ Time Frame: 1 year ]Compare the prevalence of pre-defined potential etiology between the predominant-symptom subgroups.
- Prognostic indicators for idiopathic gastroparesis [ Time Frame: 3 years ]Odd-ratios for developing the poor and good outcome during follow-up will be determined for pred-defined potential prognostic indictors obtained at the baseline visit.
- Prevalence of obesity, metabolic syndrome and impaired glucose tolerance [ Time Frame: 1 year ]Prevalence of obesity, metabolic syndrome and impaired glucose tolerance will be compared between the predominant-symptom subgroups and Subjects with and without gastroparesis complications.
Biospecimen Retention: Samples Without DNA
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01173484
|United States, Kentucky|
|University of Louisville|
|Louisville, Kentucky, United States, 40205|
|Principal Investigator:||John M. Wo, MD||University of Louisville School of Medicine|