GastroparesisGpR3NCT03680859
Gastroparesis Registry 3
An observational study of Gastroparesis and Diabetic Gastroparesis, run by Johns Hopkins Bloomberg School of Public Health at 6 sites in United States.
Trial summary
The purpose of this study is to create a new registry of patients with gastroparesis in order to better understand the characteristics of patients with gastroparesis and follow how their condition changes over time. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastroparesis, Diabetic Gastroparesis, Idiopathic Gastroparesis
- How many people
- 406 participants
- Where
- 6 sitesUnited States
- Study dates
- 24 Jan 2019to 13 May 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Males and females at least 18 years old at the initial screening interview in the United States who are: * Diabetic, idiopathic, or post-fundoplication gastroparesis patients with delayed gastric emptying * Diabetic, idiopathic, or post-fundoplication patients with symptoms of gastroparesis but with normal gastric emptying
Who may be able to join
- Symptoms of gastroparesis of at least 12 weeks' duration with varying degrees of nausea, vomiting, early satiety, postprandial fullness
- An etiology of either diabetic, idiopathic, or post-fundoplication (Nissen, Dor, or Toupet) gastroparesis or gastroparesis-like disorder (symptoms of gastroparesis but normal gastric emptying)
- Gastric emptying scintigraphy of solids using the 4-hour Egg Beaters® protocol (or equivalent generic liquid egg white meal) within the last 6 months with either:
- Abnormal gastric emptying rate defined as an abnormal 2 hour (>60% retention) and/or 4 hour (>10% retention) result based on a 4 hour scintigraphic gastric emptying study. (This group will comprise ~75% of patients in the registry.)
- Patients with a normal gastric emptying rate, but who have symptoms of gastroparesis. (This group will comprise ~25% of patients in the registry.)
- Negative upper endoscopy or upper radiographic GI series within 2 years of registration
- Age at least 18 years at initial screening visit
Who cannot join
- Inability to comply with or complete the gastric emptying test by scintigraphy (including allergy to eggs)
- Use of narcotic analgesics greater than three days per week
- Presence of other conditions that could explain the patient's symptoms:
- Pyloric or intestinal obstruction: by EGD, UGI, or Abdominal CT
- Active inflammatory bowel disease
- Known eosinophilic gastroenteritis or eosinophilic esophagitis
Show all 14Show fewer
- Primary neurological conditions that can cause nausea and vomiting such as increased intracranial pressure, space occupying or inflammatory/infectious lesions
- Acute renal failure
- Chronic renal failure (serum creatinine >3 mg/dL) and/or on hemodialysis or peritoneal dialysis
- Acute liver failure
- Advanced liver disease (Child's B or C; a Child-Pugh-Turcotte (CPT) score of ≥7)
- Prior gastric surgery including total or subtotal (near complete) gastric resection, esophagectomy, gastrojejunostomy, gastric bypass, gastric sleeve, pyloroplasty, pyloromyotomy. Note: patients with prior Nissen, Dor, or Toupet fundoplication will be eligible for enrollment.
- Any other condition, which in the opinion of the investigator, could explain the symptoms or interfere with study requirements
- Inability to obtain informed consent
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, 21224
Massachusetts General Hospital-Digestive Healthcare Center
Boston, Massachusetts, 02114
Texas Tech University Health Science Center (TTUHSC)
El Paso, Texas, 79905
University of Louisville
Louisville, Kentucky, 40202
Temple University Hospital
Philadelphia, Pennsylvania, 19140
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
About this study
Official title: The NIDDK Gastroparesis Registry 3: Characterization and Clinical Course of Symptoms and Gastric Emptying in Patients With Symptoms of Gastroparesis
The purpose of this study is to create a new registry of patients with gastroparesis in order to better understand the characteristics of patients with gastroparesis and follow how their condition changes over time. The data collected may improve the understanding of the condition to enable better diagnosis and treatment.
Read the detailed description
GpR 3 is an observational study of patients with symptoms of gastroparesis with either delayed or normal gastric emptying. Epidemiological, clinical, physiological, and patient outcome data will be collected to characterize the patients and their clinical course to better understand this disorder. The long-term goal is to help phenotype patients into pathophysiologically defined subsets. This classification will provide a foundation for translational research, facilitating the search for etiopathogenesis and enhance the ability to define and conduct large clinical trials, ultimately leading to the development of more rational and effective therapeutic approaches for gastroparesis.
The primary objectives of the Gastroparesis Registry 3 (GpR 3) are:
- To create a new registry of patients with symptoms of gastroparesis, both patients with delayed gastric emptying and patients with similar symptoms but normal gastric emptying, for the enhanced study of symptoms, gastric motility abnormalities, patient characteristics, and degree of morbidity.
- To follow a well-characterized cohort to further define the natural history and clinical course of patients with symptoms of gastroparesis - both symptoms and gastric emptying over time. Treatments given for their clinical care and clinical responses to treatments will be recorded.
- To provide a reliable source for recruitment of well-characterized patients with gastroparesis for other studies including therapeutic clinical trials, pathophysiological, molecular, histopathologic, or other ancillary studies. These subsequent clinical trials or ancillary studies will be conducted under separate study protocols with separate consent processes.
Specific secondary objectives of GpR3 have been developed to allow the patients entered in GpR3 to help advance our understanding of gastroparesis:
- Assess several areas of gastric motility in patients with symptoms of gastroparesis (fundic accommodation, antral contractility, global gastric emptying).
- Determine the change in gastric motility over time, in patients with gastroparesis and in patients with symptoms of gastroparesis but normal gastric emptying.
- Evaluate the clinical symptomatic course (outcome) of patients followed in the registry.
- Use the registry to better capture clinical treatment responses to specific treatments while patients are in the registry.
- Characterize abdominal pain in patients with gastroparesis and gastroparesis-like syndrome by:
- Describing the abdominal pain seen in patients with gastroparesis
- Determining if the pain has neuropathic or nociceptive qualities
- Determining attributes of patients with abdominal pain
- Assessing patients in the presence of sensory gastric dysfunction
- Objective mapping of the abdominal pain and determining central and/or peripheral attributes of the abdominal pain
- Compare the Rome IV categories of gastric disorders (functional dyspepsia (FD), epigastric pain syndrome (EPS), postprandial distress syndrome (PDS), chronic idiopathic nausea and vomiting (CINV), rumination syndrome, cyclic vomiting syndrome, central abdominal pain syndrome) to our present classification of gastroparesis and gastroparesis-like disorder.
- Determine the prevalence of hypermobility spectrum disorders (HSD) in patients with gastroparesis.
- Compare the water load satiety test (WLST) to intragastric meal distribution (IMD) during scintigraphy and to symptoms of early satiety, postprandial fullness in patients with symptoms of gastroparesis.
- Collect serum, plasma, and peripheral blood mononuclear cells (PBMC) that can be used for subsequent analysis to address specific research questions.
- Medical subject headings
- Gastroparesis
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 |
|---|---|---|
| Diabetic | Participants with a primary etiology of diabetic gastroparesis | |
| Idiopathic | Participants with a primary etiology of idiopathic gastroparesis | |
| Post-fundoplication | Participants with a primary etiology of post-Nissen fundoplication gastroparesis | |
| Diabetic with Normal Emptying | Diabetic participants with symptomatic nausea and vomiting with normal gastric emptying | |
| Idiopathic with Normal Emptying | Idiopathic participants with symptomatic nausea and vomiting with normal gastric emptying | |
| Post-fundoplication with Normal Emptying | Post-fundoplication participants with symptomatic nausea and vomiting with normal gastric emptying |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline GSCI score at 48 weeks
The outcome is assessed using the self-reported postprandial fullness/early satiety subscore, which is computed as the average of 4 scores for 4-items on the Gastroparesis Cardinal Symptom Index (GCSI) survey: stomach fullness, inability to finish a normal-sized meal, feeling excessively full after meals, and loss of appetite. Each item is scored from 0 (no) to 5 (very severe) symptoms in the past 2-weeks; the subscore ranges from 0 to 5. The change is computed as the subscore at 48-weeks minus the baseline subscore.
Measured: Baseline to 48 weeks
Secondary outcomes (2)
Change from baseline in Short Form Health Survey (SF-36v2) physical health QOL component score at 48 weeks
The outcome is assessed using the self-reported 36-item Short Form Health Survey (SF-36v2) physical health QOL component score. The score ranges from 0 (poorest) to 100 (highest) QOL. The change is computed as the score at 48-weeks minus the baseline score.
Measured: Baseline to 48 weeks
Change from baseline in Short Form Health Survey (SF-36v2) mental health QOL component score at 48 weeks
The outcome is assessed using the self-reported 36-item Short Form Health Survey (SF-36v2) mental health QOL component score. The score ranges from 0 (poorest) to 100 (highest) QOL. The change is computed as the score at 48-weeks minus the baseline score.
Measured: Baseline to 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2018
- Study start24 Jan 2019
- Primary completion13 May 2024
- Study completion13 May 2024
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.
- 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
- 406 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins Bloomberg School of Public Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Johns Hopkins University, Massachusetts General Hospital, Temple University, University of Louisville, Wake Forest University, Texas Tech University Health Sciences Center, El Paso
- Responsible party
- Sponsor
- Investigators
- Henry Parkman, MD, Study chair, Temple University HospitalBraden Kuo, MD, Study chair, Massachusetts General HospitalPankaj J Pasricha, MD, Study chair, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03680859
- Sponsor's protocol ID
- 7 DK GpR3
- Other IDs
- U01DK073983, U01DK112193, U01DK073975, U01DK074035, U01DK074007, U01DK073974, U24DK074008
- Acronym
- GpR3
- Status last verified
- May 2024
- First submitted
- 7 Sep 2018
- Last updated
- 24 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Public use complete database will be submitted to the NIDDK Data Repository
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The NIDDK Gastroparesis Registry 3: Characterization and Clinical Course of Symptoms and Gastric Emptying in Patients With Symptoms of Gastroparesis
- ClinicalTrials.gov ID
- NCT03680859
- Acronym / sponsor ID
- GpR3 / 7 DK GpR3
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 406 participants (actual)
- Lead sponsor
- Johns Hopkins Bloomberg School of Public HealthUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Johns Hopkins University, Massachusetts General Hospital, Temple University, University of Louisville, Wake Forest University, Texas Tech University Health Sciences Center, El Paso
- Study start
- 24 Jan 2019 (actual)
- Primary completion
- 13 May 2024 (actual)
- Study completion
- 13 May 2024 (actual)
- First posted
- 21 Sep 2018 (actual)
- 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 purpose of this study is to create a new registry of patients with gastroparesis in order to better understand the characteristics of patients with gastroparesis and follow how their condition changes over time. The data collected may improve the understanding of the condition to enable better diagnosis and treatment.
Detailed description
GpR 3 is an observational study of patients with symptoms of gastroparesis with either delayed or normal gastric emptying. Epidemiological, clinical, physiological, and patient outcome data will be collected to characterize the patients and their clinical course to better understand this disorder. The long-term goal is to help phenotype patients into pathophysiologically defined subsets. This classification will provide a foundation for translational research, facilitating the search for etiopathogenesis and enhance the ability to define and conduct large clinical trials, ultimately leading to the development of more rational and effective therapeutic approaches for gastroparesis.
The primary objectives of the Gastroparesis Registry 3 (GpR 3) are:
- To create a new registry of patients with symptoms of gastroparesis, both patients with delayed gastric emptying and patients with similar symptoms but normal gastric emptying, for the enhanced study of symptoms, gastric motility abnormalities, patient characteristics, and degree of morbidity.
- To follow a well-characterized cohort to further define the natural history and clinical course of patients with symptoms of gastroparesis - both symptoms and gastric emptying over time. Treatments given for their clinical care and clinical responses to treatments will be recorded.
- To provide a reliable source for recruitment of well-characterized patients with gastroparesis for other studies including therapeutic clinical trials, pathophysiological, molecular, histopathologic, or other ancillary studies. These subsequent clinical trials or ancillary studies will be conducted under separate study protocols with separate consent processes.
Specific secondary objectives of GpR3 have been developed to allow the patients entered in GpR3 to help advance our understanding of gastroparesis:
- Assess several areas of gastric motility in patients with symptoms of gastroparesis (fundic accommodation, antral contractility, global gastric emptying).
- Determine the change in gastric motility over time, in patients with gastroparesis and in patients with symptoms of gastroparesis but normal gastric emptying.
- Evaluate the clinical symptomatic course (outcome) of patients followed in the registry.
- Use the registry to better capture clinical treatment responses to specific treatments while patients are in the registry.
- Characterize abdominal pain in patients with gastroparesis and gastroparesis-like syndrome by:
- Describing the abdominal pain seen in patients with gastroparesis
- Determining if the pain has neuropathic or nociceptive qualities
- Determining attributes of patients with abdominal pain
- Assessing patients in the presence of sensory gastric dysfunction
- Objective mapping of the abdominal pain and determining central and/or peripheral attributes of the abdominal pain
- Compare the Rome IV categories of gastric disorders (functional dyspepsia (FD), epigastric pain syndrome (EPS), postprandial distress syndrome (PDS), chronic idiopathic nausea and vomiting (CINV), rumination syndrome, cyclic vomiting syndrome, central abdominal pain syndrome) to our present classification of gastroparesis and gastroparesis-like disorder.
- Determine the prevalence of hypermobility spectrum disorders (HSD) in patients with gastroparesis.
- Compare the water load satiety test (WLST) to intragastric meal distribution (IMD) during scintigraphy and to symptoms of early satiety, postprandial fullness in patients with symptoms of gastroparesis.
- Collect serum, plasma, and peripheral blood mononuclear cells (PBMC) that can be used for subsequent analysis to address specific research questions.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Diabetic | – | –Participants with a primary etiology of diabetic gastroparesis |
| Idiopathic | – | –Participants with a primary etiology of idiopathic gastroparesis |
| Post-fundoplication | – | –Participants with a primary etiology of post-Nissen fundoplication gastroparesis |
| Diabetic with Normal Emptying | – | –Diabetic participants with symptomatic nausea and vomiting with normal gastric emptying |
| Idiopathic with Normal Emptying | – | –Idiopathic participants with symptomatic nausea and vomiting with normal gastric emptying |
| Post-fundoplication with Normal Emptying | – | –Post-fundoplication participants with symptomatic nausea and vomiting with normal gastric emptying |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Males and females at least 18 years old at the initial screening interview in the United States who are: * Diabetic, idiopathic, or post-fundoplication gastroparesis patients with delayed gastric emptying * Diabetic, idiopathic, or post-fundoplication patients with symptoms of gastroparesis but with normal gastric emptying
Key inclusion criteria (7 listed)
- Symptoms of gastroparesis of at least 12 weeks' duration with varying degrees of nausea, vomiting, early satiety, postprandial fullness
- An etiology of either diabetic, idiopathic, or post-fundoplication (Nissen, Dor, or Toupet) gastroparesis or gastroparesis-like disorder (symptoms of gastroparesis but normal gastric emptying)
- Gastric emptying scintigraphy of solids using the 4-hour Egg Beaters® protocol (or equivalent generic liquid egg white meal) within the last 6 months with either:
- Abnormal gastric emptying rate defined as an abnormal 2 hour (>60% retention) and/or 4 hour (>10% retention) result based on a 4 hour scintigraphic gastric emptying study. (This group will comprise ~75% of patients in the registry.)
- Patients with a normal gastric emptying rate, but who have symptoms of gastroparesis. (This group will comprise ~25% of patients in the registry.)
Key exclusion criteria (14 listed)
- Inability to comply with or complete the gastric emptying test by scintigraphy (including allergy to eggs)
- Use of narcotic analgesics greater than three days per week
- Presence of other conditions that could explain the patient's symptoms:
- Pyloric or intestinal obstruction: by EGD, UGI, or Abdominal CT
- Active inflammatory bowel disease
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
Change from baseline GSCI score at 48 weeks
Time frame: Baseline to 48 weeks
The outcome is assessed using the self-reported postprandial fullness/early satiety subscore, which is computed as the average of 4 scores for 4-items on the Gastroparesis Cardinal Symptom Index (GCSI) survey: stomach fullness, inability to finish a normal-sized meal, feeling excessively full after meals, and loss of appetite. Each item is scored from 0 (no) to 5 (very severe) symptoms in the past 2-weeks; the subscore ranges from 0 to 5. The change is computed as the subscore at 48-weeks minus the baseline subscore.
2 secondary outcomes
Change from baseline in Short Form Health Survey (SF-36v2) physical health QOL component score at 48 weeks
Time frame: Baseline to 48 weeks
Change from baseline in Short Form Health Survey (SF-36v2) mental health QOL component score at 48 weeks
Time frame: Baseline to 48 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2024.
- Gastroparesis Clinical Research ConsortiumLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Public use complete database will be submitted to the NIDDK Data Repository
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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.
Henry Parkman, MD study chair
Temple University Hospital
Braden Kuo, MD study chair
Massachusetts General Hospital
Pankaj J Pasricha, MD study chair
Johns Hopkins University
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastroparesis and Diabetic Gastroparesis, run by Johns Hopkins Bloomberg School of Public Health at 6 sites 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 7 inclusion and 14 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: finished, as of the sponsor's last update on 24 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change from baseline GSCI score at 48 weeks (time frame: Baseline to 48 weeks). 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 24 May 2024.