Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
406 participants
OBSERVATIONAL
2019-01-24
2024-05-13
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Gastroparesis Registry
NCT00398801
Gastroparesis Registry 2
NCT01696747
Gastroparesis Registry 4
NCT05846802
Pyloric Sphincter Abnormalities in Patients With Gastroparesis Symptoms
NCT04661215
Idiopathic Gastroparesis Registry Using a Predominant-Symptom Classification
NCT01173484
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Diabetic
Participants with a primary etiology of diabetic gastroparesis
No interventions assigned to this group
Idiopathic
Participants with a primary etiology of idiopathic gastroparesis
No interventions assigned to this group
Post-fundoplication
Participants with a primary etiology of post-Nissen fundoplication gastroparesis
No interventions assigned to this group
Diabetic with Normal Emptying
Diabetic participants with symptomatic nausea and vomiting with normal gastric emptying
No interventions assigned to this group
Idiopathic with Normal Emptying
Idiopathic participants with symptomatic nausea and vomiting with normal gastric emptying
No interventions assigned to this group
Post-fundoplication with Normal Emptying
Post-fundoplication participants with symptomatic nausea and vomiting with normal gastric emptying
No interventions assigned to this group
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
Exclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
Johns Hopkins University
OTHER
Massachusetts General Hospital
OTHER
Temple University
OTHER
University of Louisville
OTHER
Wake Forest University
OTHER
Texas Tech University Health Sciences Center, El Paso
OTHER
Johns Hopkins Bloomberg School of Public Health
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Henry Parkman, MD
Role: STUDY_CHAIR
Temple University Hospital
Braden Kuo, MD
Role: STUDY_CHAIR
Massachusetts General Hospital
Pankaj J Pasricha, MD
Role: STUDY_CHAIR
Johns Hopkins University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Louisville
Louisville, Kentucky, United States
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, United States
Massachusetts General Hospital-Digestive Healthcare Center
Boston, Massachusetts, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
Temple University Hospital
Philadelphia, Pennsylvania, United States
Texas Tech University Health Science Center (TTUHSC)
El Paso, Texas, United States
Countries
Review the countries where the study has at least one active or historical site.
Related Links
Access external resources that provide additional context or updates about the study.
Gastroparesis Clinical Research Consortium
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
7 DK GpR3
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.