Completed

GpR2GpR 2: Continuation of the NIDDK Gastroparesis Registry for the Characterization and Clinical Course of Gastroparesis Patients

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What is being collected

Data Collection

Collected from today forward - Prospective
DNA Samples
Who is being recruted

Digestive System Diseases+5

+ Gastrointestinal Diseases

+ Neurologic Manifestations

Over 18 Years
See all eligibility criteria
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: July 2012
See protocol details

Summary

Principal SponsorJohns Hopkins Bloomberg School of Public Health
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: July 1, 2012

Actual date on which the first participant was enrolled.

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.

Official TitleGpR 2: Continuation of the NIDDK Gastroparesis Registry for the Characterization and Clinical Course of Gastroparesis Patients
NCT01696747
Principal SponsorJohns Hopkins Bloomberg School of Public Health
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

506 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.


Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Digestive System DiseasesGastrointestinal DiseasesNeurologic ManifestationsParalysisSigns and SymptomsStomach DiseasesPathological Conditions, Signs and SymptomsGastroparesis

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

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 6 locations

Suspended

University of Louisville

Louisville, United StatesOpen University of Louisville in Google Maps
Suspended

Johns Hopkins Bayview Medical Center

Baltimore, United States
Suspended

Massachusetts General Hospital-Digestive Healthcare Center

Boston, United States
Suspended

Wake Forest University Health Sciences

Winston-Salem, United States
Completed6 Study Centers