Clinical Trial: Idiopathic Gastroparesis Registry Using a Predominant-Symptom Classification

Study Status: Terminated
Recruit Status: Terminated
Study Type: Observational

Official Title: Idiopathic Gastroparesis Registry to Define Severity, Treatment Response, and Prognosis Using a Predominant-Symptom Classification

Brief Summary: 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 causes, symptoms, and prognosis among patients with idiopathic gastroparesis. Understanding these differences is necessary in order to provide effective treatment in these patients. We believe our classification for gastroparesis is a useful tool in the management of patients with idiopathic gastroparesis to predict clinical severity, treatment response, and future prognosis.

Detailed Summary:

"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.

Sponsor: University of Louisville

Current Primary Outcome: Incidence of poor outcome [ Time Frame: 3 years ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

• 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.

Original Secondary Outcome: Same as current

Information By: University of Louisville

Dates:
Date Received: July 29, 2010
Date Started: June 2010
Date Completion:
Last Updated: April 6, 2017
Last Verified: April 2017