Gastroparesis Registry 2 (GpR2)
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| ClinicalTrials.gov Identifier: NCT01696747 |
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Recruitment Status :
Completed
First Posted : October 1, 2012
Last Update Posted : February 23, 2022
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Sponsor:
Johns Hopkins Bloomberg School of Public Health
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Johns Hopkins Bloomberg School of Public Health
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Brief Summary:
To expand a registry of patients for the study of the epidemiology, etiology, and degree of morbidity associated with gastroparesis.
| Condition or disease |
|---|
| Gastroparesis Diabetic Gastroparesis Idiopathic Gastroparesis |
The Gastroparesis Registry 2 (GpR 2) will enroll new patients and patients from the initial NIDDK Gastroparesis Clinical Research Consortium Gastroparesis Registry (GpR) of gastroparesis patients which was initiated in February 2007 and completed in March 2011.
To continue to follow and expand the data collections of a well-characterized cohort to further define the natural history and clinical course of gastroparesis.
To provide a reliable source for recruitment of well-characterized patients with gastroparesis for 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.
| Study Type : | Observational |
| Actual Enrollment : | 506 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | GpR 2: Continuation of the NIDDK Gastroparesis Registry for the Characterization and Clinical Course of Gastroparesis Patients |
| Actual Study Start Date : | July 2012 |
| Actual Primary Completion Date : | April 30, 2019 |
| Actual Study Completion Date : | April 30, 2019 |
Resource links provided by the National Library of Medicine
| Group/Cohort |
|---|
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Diabetic
participants with a primary etiology of diabetic gastroparesis
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Idiopathic
participants with a primary etiology of idiopathic gastroparesis
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Post-Nissen
participants with a primary etiology of post-Nissen fundoplication gastroparesis
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Biospecimen Retention: Samples With DNA
plasma serum DNA
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
This study will enroll patients with gastroparesis and delayed gastric emptying. These patients can have either diabetic, idiopathic, or post-Nissen fundoplication gastroparesis. In addition, patients with symptoms similar to gastroparesis, but with normal gastric emptying will be enrolled as a reference group.
Criteria
Inclusion Criteria:
- Symptoms of gastroparesis of at least 12 weeks duration (do not have to be contiguous) with varying degrees of nausea, vomiting, early satiety, post-prandial fullness, and/or abdominal pain
- An etiology of either diabetic, idiopathic, or post-Nissen fundoplication gastroparesis
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Gastric emptying scintigraphy of solids and liquids test using 4 hours Egg Beaters® protocol 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 low fat Egg Beaters® gastric emptying study performed at a GpCRC clinical center.
- Patients with a normal gastric emptying rate but with symptoms of gastroparesis may be enrolled and classified as possible gastroparesis or gastroparesis-like with normal gastric emptying
- Age at least 18 years at initial screening visit
- Upper endoscopy results within last 2 years
Exclusion Criteria:
- Inability to comply with or complete the gastric emptying scintigraphy test (including allergy to eggs)
- Presence of other conditions that could explain the patient's symptoms:
- Pyloric or intestinal obstruction as determined by endoscopy, upper GI series or abdominal CT scan
- Active inflammatory bowel disease
- Known eosinophilic gastroenteritis
- Primary neurological conditions that could cause nausea and/or vomiting such as increased intracranial pressure, space occupying or inflammatory/infectious lesions
- Acute liver failure
- Advanced liver disease (Child's B or C; a Child-Pugh-Turcotte (CPT) score of ≥7 )
- Acute renal failure
- Chronic renal failure (serum creatinine >3 mg/dL) and/or on hemodialysis or peritoneal dialysis
- Total or subtotal (near complete) gastric resection, esophagogastrostomy, gastrojejunostomy, or gastric bypass. Note: patients with prior fundoplication will be eligible for enrollment.
- Any other plausible structural or metabolic cause
- Any other condition, which in the opinion of the investigator would interfere with study requirements
- Inability to obtain informed consent
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01696747
Locations
| United States, Kentucky | |
| University of Louisville | |
| Louisville, Kentucky, United States, 40202 | |
| United States, Maryland | |
| Johns Hopkins Bayview Medical Center | |
| Baltimore, Maryland, United States, 21224 | |
| United States, Massachusetts | |
| Massachusetts General Hospital-Digestive Healthcare Center | |
| Boston, Massachusetts, United States, 02114 | |
| United States, North Carolina | |
| Wake Forest University Health Sciences | |
| Winston-Salem, North Carolina, United States, 27157 | |
| United States, Pennsylvania | |
| Temple University Hospital | |
| Philadelphia, Pennsylvania, United States, 19140 | |
| United States, Texas | |
| Texas Tech University Health Sciences Center | |
| El Paso, Texas, United States, 79905 | |
Sponsors and Collaborators
Johns Hopkins Bloomberg School of Public Health
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
| Study Director: | Frank Hamilton, MD, MPH | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Johns Hopkins Bloomberg School of Public Health |
| ClinicalTrials.gov Identifier: | NCT01696747 |
| Other Study ID Numbers: |
GpCRC-GpR 2-5 U01DK073974 ( U.S. NIH Grant/Contract ) U01DK073975 ( U.S. NIH Grant/Contract ) U01DK073983 ( U.S. NIH Grant/Contract ) U01DK073985 ( U.S. NIH Grant/Contract ) U01DK074007 ( U.S. NIH Grant/Contract ) U01DK074008 ( U.S. NIH Grant/Contract ) |
| First Posted: | October 1, 2012 Key Record Dates |
| Last Update Posted: | February 23, 2022 |
| Last Verified: | February 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | Data to be shared at end of funding |
Keywords provided by Johns Hopkins Bloomberg School of Public Health:
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gastroparesis idiopathic gastroparesis diabetic gastroparesis post-Nissen gastroparesis |
Additional relevant MeSH terms:
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Gastroparesis Stomach Diseases Gastrointestinal Diseases |
Digestive System Diseases Paralysis Neurologic Manifestations |