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Gastroparesis Registry 3 (GpR3)

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ClinicalTrials.gov Identifier: NCT03680859
Recruitment Status : Not yet recruiting
First Posted : September 21, 2018
Last Update Posted : September 21, 2018
Sponsor:
Information provided by (Responsible Party):
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Brief Summary:
The purpose of this study is to create a new registry of patients with gastroparesis in order to better understand the characteristics of patients with gastroparesis and follow how their condition changes over time. The data collected may improve the understanding of the condition to enable better diagnosis and treatment.

Condition or disease
Gastroparesis Diabetic Gastroparesis Idiopathic Gastroparesis

  Show Detailed Description

Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The NIDDK Gastroparesis Registry 3: Characterization and Clinical Course of Symptoms and Gastric Emptying in Patients With Symptoms of Gastroparesis
Estimated Study Start Date : September 30, 2018
Estimated Primary Completion Date : October 30, 2022
Estimated Study Completion Date : December 30, 2022

Resource links provided by the National Library of Medicine


Group/Cohort
Diabetic
Participants with a primary etiology of diabetic gastroparesis
Idiopathic
Participants with a primary etiology of idiopathic gastroparesis
Post-fundoplication
Participants with a primary etiology of post-Nissen fundoplication gastroparesis
Diabetic with Normal Emptying
Diabetic participants with symptomatic nausea and vomiting with normal gastric emptying
Idiopathic with Normal Emptying
Idiopathic participants with symptomatic nausea and vomiting with normal gastric emptying
Post-fundoplication with Normal Emptying
Post-fundoplication participants with symptomatic nausea and vomiting with normal gastric emptying



Primary Outcome Measures :
  1. Change from baseline GSCI score at 48 weeks [ Time Frame: Baseline to 48 weeks ]
    The outcome is assessed using the self-reported postprandial fullness/early satiety subscore, which is computed as the average of 4 scores for 4-items on the Gastroparesis Cardinal Symptom Index (GCSI) survey: stomach fullness, inability to finish a normal-sized meal, feeling excessively full after meals, and loss of appetite. Each item is scored from 0 (no) to 5 (very severe) symptoms in the past 2-weeks; the subscore ranges from 0 to 5. The change is computed as the subscore at 48-weeks minus the baseline subscore.


Secondary Outcome Measures :
  1. Change from baseline in Short Form Health Survey (SF-36v2) physical health QOL component score at 48 weeks [ Time Frame: Baseline to 48 weeks ]
    The outcome is assessed using the self-reported 36-item Short Form Health Survey (SF-36v2) physical health QOL component score. The score ranges from 0 (poorest) to 100 (highest) QOL. The change is computed as the score at 48-weeks minus the baseline score.

  2. Change from baseline in Short Form Health Survey (SF-36v2) mental health QOL component score at 48 weeks [ Time Frame: Baseline to 48 weeks ]
    The outcome is assessed using the self-reported 36-item Short Form Health Survey (SF-36v2) mental health QOL component score. The score ranges from 0 (poorest) to 100 (highest) QOL. The change is computed as the score at 48-weeks minus the baseline score.


Biospecimen Retention:   Samples Without DNA
Plasma, serum, and PBMC specimens


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Males and females at least 18 years old at the initial screening interview in the United States who are:

  • Diabetic, idiopathic, or post-fundoplication gastroparesis patients with delayed gastric emptying
  • Diabetic, idiopathic, or post-fundoplication patients with symptoms of gastroparesis but with normal gastric emptying
Criteria

Inclusion Criteria:

  • Symptoms of gastroparesis of at least 12 weeks' duration with varying degrees of nausea, vomiting, early satiety, postprandial fullness
  • An etiology of either diabetic, idiopathic, or post-fundoplication (Nissen, Dor, or Toupet) gastroparesis or gastroparesis-like disorder (symptoms of gastroparesis but normal gastric emptying)
  • Gastric emptying scintigraphy of solids using the 4-hour Egg Beaters® protocol (or equivalent generic liquid egg white meal) 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 gastric emptying study. (This group will comprise ~75% of patients in the registry.)
  • Patients with a normal gastric emptying rate, but who have symptoms of gastroparesis. (This group will comprise ~25% of patients in the registry.)
  • Negative upper endoscopy or upper radiographic GI series within 2 years of registration
  • Age at least 18 years at initial screening visit

Exclusion Criteria:

  • Inability to comply with or complete the gastric emptying test by scintigraphy (including allergy to eggs)
  • Use of narcotic analgesics greater than three days per week
  • Presence of other conditions that could explain the patient's symptoms:
  • Pyloric or intestinal obstruction: by EGD, UGI, or Abdominal CT
  • Active inflammatory bowel disease
  • Known eosinophilic gastroenteritis or eosinophilic esophagitis
  • Primary neurological conditions that can cause nausea and vomiting such as increased intracranial pressure, space occupying or inflammatory/infectious lesions
  • Acute renal failure
  • Chronic renal failure (serum creatinine >3 mg/dL) and/or on hemodialysis or peritoneal dialysis
  • Acute liver failure
  • Advanced liver disease (Child's B or C; a Child-Pugh-Turcotte (CPT) score of ≥7)
  • Prior gastric surgery including total or subtotal (near complete) gastric resection, esophagectomy, gastrojejunostomy, gastric bypass, gastric sleeve, pyloroplasty, pyloromyotomy. Note: patients with prior Nissen, Dor, or Toupet fundoplication will be eligible for enrollment.
  • Any other condition, which in the opinion of the investigator, could explain the symptoms or interfere with study requirements
  • Inability to obtain informed consent

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): NCT03680859


Contacts
Contact: Laura Miriel (410) 955-4165 laura.miriel@jhu.edu

Locations
United States, Kentucky
University of Louisville
Louisville, Kentucky, United States, 40202
United States, Maryland
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, United States, 21224
United States, Massachusetts
Massachusetts General Hospital-Digestive Healthcare Center
Boston, Massachusetts, United States, 02114
United States, North Carolina
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
United States, Pennsylvania
Temple University Hospital
Philadelphia, Pennsylvania, United States, 19140
United States, Texas
Texas Tech University Health Science Center (TTUHSC)
El Paso, Texas, United States, 79905
Sponsors and Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Study Director: Jose Serrano, MD, PhD National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study Director: Frank Hamilton, MD, MPH National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study Chair: Henry Parkman, MD Temple University Hospital
Study Chair: Braden Kuo, MD Massachusetts General Hospital
Study Chair: Pankaj J Pasricha, MD Johns Hopkins University

Additional Information:
Responsible Party: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier: NCT03680859     History of Changes
Other Study ID Numbers: 7 DK GpR3
U01DK073983 ( U.S. NIH Grant/Contract )
U01DK112193 ( U.S. NIH Grant/Contract )
U01DK073975 ( U.S. NIH Grant/Contract )
U01DK074035 ( U.S. NIH Grant/Contract )
U01DK074007 ( U.S. NIH Grant/Contract )
U01DK073974 ( U.S. NIH Grant/Contract )
U24DK074008 ( U.S. NIH Grant/Contract )
First Posted: September 21, 2018    Key Record Dates
Last Update Posted: September 21, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Public use complete database will be submitted to the NIDDK Data Repository
Supporting Materials: Study Protocol
Informed Consent Form (ICF)
Analytic Code
Time Frame: By the end of the funding period
Access Criteria: Application through NIDDK Data Repository; IRB approval
URL: http://repository.niddk.nih.gov/home/

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

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