Gastroparesis Registry 2 (GpR2)

Johns Hopkins Bloomberg School of Public Health

Status

Completed

Conditions

Diabetic Gastroparesis

Gastroparesis

Idiopathic Gastroparesis

Study type

Observational

Funder types

Other

NIH

Identifiers

NCT01696747

U01DK074008 (U.S. NIH Grant/Contract)

U01DK073974 (U.S. NIH Grant/Contract)

U01DK073983 (U.S. NIH Grant/Contract)

U01DK074007 (U.S. NIH Grant/Contract)

U01DK073975 (U.S. NIH Grant/Contract)

U01DK073985 (U.S. NIH Grant/Contract)

GpCRC-GpR 2-5

Details and patient eligibility

About

To expand a registry of patients for the study of the epidemiology, etiology, and degree of morbidity associated with gastroparesis.

Full 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.

Enrollment

506 patients

Sex

All

Ages

18+ years old

Volunteers

No 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