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Trial record 2 of 1525 for:    NIDDK

Gastroparesis Registry 2 (GpR2)

This study is currently recruiting participants.
Verified September 2017 by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01696747
First Posted: October 1, 2012
Last Update Posted: September 14, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  Purpose
To expand a registry of patients for the study of the epidemiology, etiology, and degree of morbidity associated with gastroparesis.

Condition
Gastroparesis Diabetic Gastroparesis Idiopathic Gastroparesis

Study Type: Observational
Study Design: 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

Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Biospecimen Retention:   Samples With DNA
plasma serum DNA

Estimated Enrollment: 500
Study Start Date: July 2012
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: November 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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.
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01696747


Locations
United States, Kentucky
University of Louisville Recruiting
Louisville, Kentucky, United States, 40202
Contact: Thomas Abell, MD    502-852-7963    thomas.abell@louisville.edu   
Contact: Ronna Howard    (502) 540-1428    rshowa01@louisville.edu   
Principal Investigator: Thomas Abell, MD         
United States, Maryland
Johns Hopkins Bayview Medical Center Recruiting
Baltimore, Maryland, United States, 21224
Contact: Pankaj Pasricha, MD    410-550-6871    ppasric1@jhmi.edu   
Contact: Robert Burns    (410) 550-6871    rburns22@jhmi.edu   
Principal Investigator: Pankaj J Pasricha, MD         
United States, Massachusetts
Massachusetts General Hospital-Digestive Healthcare Center Recruiting
Boston, Massachusetts, United States, 02114
Contact: Braden Kuo, MD    617-726-0196    bkuo@partners.org   
Contact: Haewon Park    617-726-0196    hpark28@mgh.harvard.edu   
United States, North Carolina
Wake Forest University Health Sciences Recruiting
Winston-Salem, North Carolina, United States, 27157
Contact: Kenneth L Koch, MD    336-713-7333    kkoch@wakehealth.edu   
Contact: Anya Brown    (336) 716-4325    anybrown@wakehealth.edu   
Principal Investigator: Kenneth L Koch, MD         
United States, Pennsylvania
Temple University Hospital Recruiting
Philadelphia, Pennsylvania, United States, 19140
Contact: Henry P Parkman, MD    215-707-7579    henry.parkman@temple.edu   
Contact: Amiya Palit    215-707-5477    amiya.palit@temple.edu   
Principal Investigator: Henry P Parkman, MD         
United States, Texas
Texas Tech University Health Sciences Center Recruiting
El Paso, Texas, United States, 79905
Contact: Richard W McCallum, MD    915-545-6618    richard.mccallum@ttuhsc.edu   
Contact: Natalia Vega, RN    (915) 545-7399    Natalia.vega@ttuhsc.edu   
Principal Investigator: Richard W McCallum, MD         
Sub-Investigator: Irene Sarosiek, MD         
Sponsors and Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Study Director: Frank Hamilton, MD, MPH National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  More Information

Additional Information:
Responsible Party: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier: NCT01696747     History of Changes
Other Study ID Numbers: 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 )
First Submitted: September 27, 2012
First Posted: October 1, 2012
Last Update Posted: September 14, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data to be shared at end of funding

Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):
gastroparesis
idiopathic gastroparesis
diabetic gastroparesis
post-Nissen gastroparesis

Additional relevant MeSH terms:
Gastroparesis
Stomach Diseases
Gastrointestinal Diseases
Digestive System Diseases
Paralysis
Neurologic Manifestations
Signs and Symptoms