Idiopathic Gastroparesis Registry Using a Predominant-Symptom Classification

NCT01173484 | Terminated

• 1 other identifier: 09-0569
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastroparesis

Keywords

Idiopathic gastroparesis; Vomiting; Dyspepsia; GERD

Outcome Measures

Primary Outcomes (1)

• Incidence of poor outcome

  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

  3 years

Secondary Outcomes (5)

• Clinical severity

  1 year

• Incidence of treatment success

  3 years

• Potential etiology of "idiopathic" gastroparesis

  1 year

• Prognostic indicators for idiopathic gastroparesis

  3 years

• Prevalence of obesity, metabolic syndrome and impaired glucose tolerance

  1 year

Study Arms (3)

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

Eligibility Criteria

• Age: 16 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Louisville: lead

Study Sites (1)

University of Louisville

Louisville, Kentucky, 40205, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum

MeSH Terms

Conditions

Gastroparesis; Vomiting; Dyspepsia; Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Stomach Diseases; Gastrointestinal Diseases; Digestive System Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases

Study Officials

• John M. Wo, MD

  University of Louisville School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2010
• First Posted: August 2, 2010
• Study Start: June 1, 2010
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2011
• Last Updated: April 10, 2017

Record last verified: 2017-04

Locations

US (1)