GastroparesisNCT01173484
Idiopathic Gastroparesis Registry Using a Predominant-Symptom Classification
An observational study of Gastroparesis, run by University of Louisville at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 80 years
- Conditions the study is for
- Gastroparesis
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2010to Aug 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Subjects presenting to the University of Louisville Motility Center with newly diagnosis of idiopathic gastroparesis
Who may be able to join
- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Louisville
Louisville, Kentucky, 40205
About this study
Official title: Idiopathic Gastroparesis Registry to Define Severity, Treatment Response, and Prognosis Using a Predominant-Symptom Classification
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.
Read the 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.
- Conditions
- Gastroparesis
- Keywords
- Idiopathic gastroparesis, Vomiting, Dyspepsia, GERD
- Medical subject headings
- Gastroparesis, Vomiting, Dyspepsia, Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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:
- 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
Measured: 3 years
Secondary outcomes (5)
Clinical severity
Compare the prevalence of the pre-defined indicators of clinical severity between subjects with vomiting-predominant, dyspepsia-predominant, and regurgitation-predominant at study baseline.
Measured: 1 year
Incidence of treatment success
Compare the incidence of pre-defined indicators of treatment success between the predominant-symptom subgroups.
Measured: 3 years
Potential etiology of "idiopathic" gastroparesis
Compare the prevalence of pre-defined potential etiology between the predominant-symptom subgroups.
Measured: 1 year
Prognostic indicators for idiopathic gastroparesis
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.
Measured: 3 years
Prevalence of obesity, metabolic syndrome and impaired glucose tolerance
Prevalence of obesity, metabolic syndrome and impaired glucose tolerance will be compared between the predominant-symptom subgroups and Subjects with and without gastroparesis complications.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2010 (estimated)
- Study startJun 2010
- Primary completionAug 2011
- Study completionAug 2011
Why it stopped: Principal investigator has left the Institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GastroparesisStudies of the same condition, open and under way.
- More trials run by University of LouisvilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Louisville
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- John M. Wo, MD, Principal investigator, University of Louisville School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01173484
- Sponsor's protocol ID
- 09-0569
- Status last verified
- Apr 2017
- First submitted
- 29 Jul 2010
- Last updated
- 10 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Idiopathic Gastroparesis Registry to Define Severity, Treatment Response, and Prognosis Using a Predominant-Symptom Classification
- ClinicalTrials.gov ID
- NCT01173484
- Acronym / sponsor ID
- 09-0569
- Conditions
- Gastroparesis
- Keywords
- Idiopathic gastroparesis, Vomiting, Dyspepsia, GERD
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Principal investigator has left the Institution
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of LouisvilleUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 2 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 16 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Subjects presenting to the University of Louisville Motility Center with newly diagnosis of idiopathic gastroparesis
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (16 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
5 secondary outcomes
Clinical severity
Time frame: 1 year
Incidence of treatment success
Time frame: 3 years
Potential etiology of "idiopathic" gastroparesis
Time frame: 1 year
Prognostic indicators for idiopathic gastroparesis
Time frame: 3 years
Prevalence of obesity, metabolic syndrome and impaired glucose tolerance
Time frame: 1 year
Results and safety
The study was stopped early (reason given: Principal investigator has left the Institution). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John M. Wo, MD principal investigator
University of Louisville School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastroparesis, run by University of Louisville at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 10 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Principal investigator has left the Institution). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of poor outcome (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2017.