Gastroparesis Registry 2 (GpR2)
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Purpose
To expand a registry of patients for the study of the epidemiology, etiology, and degree of morbidity associated with gastroparesis.
| Condition |
|---|
|
Gastroparesis Diabetic Gastroparesis Idiopathic Gastroparesis |
| Study Type: | Observational |
| Study Design: | 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 |
plasma serum DNA
| Estimated Enrollment: | 500 |
| Study Start Date: | July 2012 |
| Estimated Study Completion Date: | September 2016 |
| Estimated Primary Completion Date: | September 2015 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
Diabetic
participants with a primary etiology of diabetic gastroparesis
|
|
Idiopathic
participants with a primary etiology of idiopathic gastroparesis
|
|
Post-Nissen
participants with a primary etiology of post-Nissen fundoplication gastroparesis
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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.
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
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
Contacts and Locations| Contact: James Tonascia, PhD | (410) 955-3704 | jtonasci@jhsph.edu |
| Contact: Aynur Unalp-Arida, MD, PhD | (410) 614-4851 | aunalp@jhsph.edu |
| United States, California | |
| California Pacific Medical Center | Recruiting |
| San Francisco, California, United States, 94115 | |
| Contact: William Snape, MD 415-516-9127 snapew@sutterhealth.org | |
| Contact: Lisa Di Maio, RN (415) 600-1155 DiMaioL@cpmcri.org | |
| Sub-Investigator: William Snape, MD | |
| Stanford University | Recruiting |
| Stanford, California, United States, 94305-5187 | |
| Contact: Linda Nguyen, MD 650-725-3362 nguyenlb@stanford.edu | |
| Contact: Nighat Ullah, MD (650) 723-3567 nullah@stanford.edu | |
| Sub-Investigator: Linda B Nguyen, MD | |
| United States, Kentucky | |
| University of Louisville | Recruiting |
| Louisville, Kentucky, United States, 40202 | |
| Contact: Thomas Abell, MD 502-852-7963 thomas.abell@louisville.edu | |
| Contact: Karen Beatty, RN (502) 540-1428 karen.beatty@louisville.edu | |
| Principal Investigator: Thomas Abell, MD | |
| United States, Maryland | |
| Johns Hopkins Bayview Medical Center | Not yet recruiting |
| Baltimore, Maryland, United States, 21224 | |
| Contact: Pankaj Pasricha, MD 410-550-1793 ppasric1@jhmi.edu | |
| Principal Investigator: Pankaj J Pasricha, MD | |
| United States, Michigan | |
| University of Michigan Medical Center | Recruiting |
| Ann Arbor, Michigan, United States, 48109 | |
| Contact: William L Hasler, MD 734-936-8644 whasler@umich.edu | |
| Contact: Nara Wootten (734) 615-6723 smao@med.umich.edu | |
| Principal Investigator: William L Hasler, MD | |
| United States, North Carolina | |
| Wake Forest University Health Sciences | Recruiting |
| Winston-Salem, North Carolina, United States, 27157 | |
| Contact: Kenneth L Koch, MD 336-713-7333 kkoch@wakehealth.edu | |
| Contact: Judy Hooker 336-713-7301 jhooker@wakehealth.edu | |
| Principal Investigator: Kenneth L Koch, MD | |
| United States, Pennsylvania | |
| Temple University Hospital | Recruiting |
| Philadelphia, Pennsylvania, United States, 19140 | |
| Contact: Henry P Parkman, MD 215-707-7579 henry.parkman@temple.edu | |
| Contact: Kellie Simmons, CRNP 215-707-5477 kellie.simmons@temple.edu | |
| Principal Investigator: Henry P Parkman, MD | |
| United States, Texas | |
| Texas Tech University Health Sciences Center | Recruiting |
| El Paso, Texas, United States, 79905 | |
| Contact: Richard W McCallum, MD 915-545-6618 richard.mccallum@ttuhsc.edu | |
| Contact: Natalia Vega, RN (915) 545-7399 Natalia.vega@ttuhsc.edu | |
| Principal Investigator: Richard W McCallum, MD | |
| Sub-Investigator: Irene Sarosiek, MD | |
| Study Director: | Frank Hamilton, MD, MPH | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
More Information
Additional Information:
No publications provided
| Responsible Party: | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
| ClinicalTrials.gov Identifier: | NCT01696747 History of Changes |
| Other Study ID Numbers: | GpCRC-GpR 2-5 |
| Study First Received: | September 27, 2012 |
| Last Updated: | March 27, 2013 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):
|
gastroparesis idiopathic gastroparesis diabetic gastroparesis post-Nissen gastroparesis |
Additional relevant MeSH terms:
|
Gastroparesis Stomach Diseases Gastrointestinal Diseases Digestive System Diseases |
Paralysis Neurologic Manifestations Signs and Symptoms |
ClinicalTrials.gov processed this record on May 23, 2013