Gastroparesis Registry 2 (GpR2)

This study is currently recruiting participants.
Verified April 2014 by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Sponsor:
Information provided by (Responsible Party):
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:
NCT01696747
First received: September 27, 2012
Last updated: April 2, 2014
Last verified: April 2014

September 27, 2012
April 2, 2014
July 2012
September 2015   (final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT01696747 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
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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
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
500
September 2016
September 2015   (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
Both
18 Years and older
No
Contact: James Tonascia, PhD (410) 955-3704 jtonasci@jhsph.edu
Contact: Aynur Unalp-Arida, MD, PhD (410) 614-4851 aunalp@jhsph.edu
United States
 
NCT01696747
GpCRC-GpR 2-5
Yes
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)
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP