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Gastroparesis Registry 2 (GpR2)

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ClinicalTrials.gov Identifier: NCT01696747
Recruitment Status : Active, not recruiting
First Posted : October 1, 2012
Last Update Posted : March 29, 2018
Sponsor:
Information provided by (Responsible Party):
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Study Description
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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

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.


Study Design
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Study Type : Observational
Estimated Enrollment : 500 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
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : March 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort
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


Outcome Measures
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Biospecimen Retention:   Samples With DNA
plasma serum DNA

Eligibility Criteria
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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

  • 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
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
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)
More Information
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:
Gastroparesis Clinical Research Consortium  This link exits the ClinicalTrials.gov site

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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
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: March 29, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data to be shared at end of funding

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