GpR2: Gastroparesis Registry 2

Sponsor

Johns Hopkins Bloomberg School of Public Health (Other)

Overall Status

Completed

CT.gov ID

NCT01696747

Collaborator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (NIH)

506

Enrollment

Locations

81.9

Actual Duration (Months)

84.3

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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	Intervention/Treatment	Phase
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

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 :

Jul 1, 2012

Actual Primary Completion Date :

Apr 30, 2019

Actual Study Completion Date :

Apr 30, 2019

Arms and Interventions

Arm	Intervention/Treatment
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

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	University of Louisville	Louisville	Kentucky	United States	40202
2	Johns Hopkins Bayview Medical Center	Baltimore	Maryland	United States	21224
3	Massachusetts General Hospital-Digestive Healthcare Center	Boston	Massachusetts	United States	02114
4	Wake Forest University Health Sciences	Winston-Salem	North Carolina	United States	27157
5	Temple University Hospital	Philadelphia	Pennsylvania	United States	19140
6	Texas Tech University Health Sciences Center	El Paso	Texas	United States	79905