Gastroparesis Registry 2 (GpR2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01696747
Recruitment Status : Active, not recruiting
First Posted : October 1, 2012
Last Update Posted : March 29, 2018
Information provided by (Responsible Party):
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

September 27, 2012
October 1, 2012
March 29, 2018
July 2012
March 2019   (Final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT01696747 on Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
Gastroparesis Registry 2
GpR 2: Continuation of the NIDDK Gastroparesis Registry for the Characterization and Clinical Course of Gastroparesis Patients
To expand a registry of patients for the study of the epidemiology, etiology, and degree of morbidity associated with gastroparesis.

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.

Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
plasma serum DNA
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.
  • Gastroparesis
  • Diabetic Gastroparesis
  • Idiopathic Gastroparesis
Not Provided
  • 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

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Active, not recruiting
March 2019
March 2019   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
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 )
Not Provided
Plan to Share IPD: Yes
Plan Description: Data to be shared at end of funding
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Not Provided
Study Director: Frank Hamilton, MD, MPH National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
March 2018