Idiopathic Gastroparesis Registry Using a Predominant-Symptom Classification

This study has been terminated.
(Principal investigator has left the Institution)
Sponsor:
Information provided by:
University of Louisville
ClinicalTrials.gov Identifier:
NCT01173484
First received: July 29, 2010
Last updated: August 4, 2011
Last verified: August 2011
  Purpose

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.


Condition
Gastroparesis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Idiopathic Gastroparesis Registry to Define Severity, Treatment Response, and Prognosis Using a Predominant-Symptom Classification

Resource links provided by NLM:


Further study details as provided by University of Louisville:

Primary Outcome Measures:
  • Incidence of poor outcome [ Time Frame: 3 years ] [ Designated as safety issue: No ]

    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



Secondary Outcome Measures:
  • Clinical severity [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Compare the incidence of pre-defined indicators of treatment success between the predominant-symptom subgroups.

  • Potential etiology of "idiopathic" gastroparesis [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Compare the prevalence of pre-defined potential etiology between the predominant-symptom subgroups.

  • Prognostic indicators for idiopathic gastroparesis [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

Serum


Enrollment: 15
Study Start Date: June 2010
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

Detailed Description:

"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.

  Eligibility

Ages Eligible for Study:   16 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Subjects presenting to the University of Louisville Motility Center with newly diagnosis of idiopathic gastroparesis

Criteria

Inclusion Criteria:

  • Symptoms of gastroparesis (nausea, vomiting, bloating, dyspepsia, early satiety, or effortless regurgitation) >1 month in duration.
  • Abnormal 4-hour gastric emptying scan within the past 3 months.
  • Initial investigation, based on the AGA Technical Review for gastroparesis, is non-diagnostic for an underlying cause

Exclusion Criteria:

  • Presence of endocrine or metabolic diseases: type 1 or type 2 diabetes, hypothyroidism, renal failure, adrenal insufficiency.
  • Presence of post-surgical gastroparesis: gastric surgery with vagotomy (with or without gastric resection, esophagectomy; surgery without vagotomy (fundoplication, bariatric surgery, heart-lung transplant).
  • Presence of neuromuscular diseases: multiple sclerosis, chronic idiopathic demyelinating polyneuropathy, myotonic dystrophy.
  • Presence of connective tissue diseases: systemic sclerosis, mixed connective tissue disorder, polymyositis, dermatomyositis, lupus.
  • Presence of autonomic diseases: Central (Parkinson, multiple system atrophy, Lewy body disease, brainstem disease) or Peripheral (idiopathic dysautonomia, amyloidosis, immune-mediated disease, vitamin B12 deficiency, mitochondrial disorder, porphyria, hereditary sensory autonomic neuropathy).
  • Presence of paraneoplastic syndrome: small cell lung cancer, multiple myeloma, breast cancer, lymphomas, pancreatic cancer.
  • Taking dopamine agonists on a daily basis.
  • Presence of known viral infection (Epstein-Barr, cytomegalovirus, herpes simplex, rotavirus), Chagas disease.
  • Presence of gastric outlet, small bowel or colon mechanical obstruction.
  • Presence of gastric electrical stimulator.
  • Non-ambulatory patients: bed-ridden, nursing home resident, etc.
  • Presence of active cancer or undergoing cancer treatment.
  • Less than 16 years old.
  • Pregnancy.
  • Unable to provide informed consent.
  • Prisoners.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01173484

Locations
United States, Kentucky
University of Louisville
Louisville, Kentucky, United States, 40205
Sponsors and Collaborators
University of Louisville
Investigators
Principal Investigator: John M. Wo, MD University of Louisville School of Medicine
  More Information

No publications provided

Responsible Party: John M. Wo, M.D., University of Louisville
ClinicalTrials.gov Identifier: NCT01173484     History of Changes
Other Study ID Numbers: 09-0569
Study First Received: July 29, 2010
Last Updated: August 4, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Louisville:
Idiopathic gastroparesis
Vomiting
Dyspepsia
GERD

Additional relevant MeSH terms:
Gastroparesis
Stomach Diseases
Gastrointestinal Diseases
Digestive System Diseases
Paralysis
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on September 30, 2014