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Gastroparesis Registry 4 (GpR4)

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ClinicalTrials.gov Identifier: NCT05846802
Recruitment Status : Not yet recruiting
First Posted : May 6, 2023
Last Update Posted : May 9, 2024
Sponsor:
Collaborators:
Texas Tech University Health Sciences Center, El Paso
Temple University
University of Louisville
Mayo Clinic
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Massachusetts General Hospital
Wake Forest University
Information provided by (Responsible Party):
Johns Hopkins Bloomberg School of Public Health

Study Description
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Brief Summary:
The Gastroparesis Registry 4 (GpR4) is an observational study of patients with symptoms of gastroparesis (Gp) and functional dyspepsia (FD) with either delayed or normal gastric emptying. To better understand these disorders, this registry will capture demographic, clinical, physiological, questionnaire, and patient outcome data to characterize the patients and their clinical course. Participants will complete several questionnaires, complete a nutrient drink test and have a gastric emptying study.

Condition or disease
Gastroparesis Gastroparesis Nondiabetic Gastroparesis Due to Diabetes Mellitus Type I Gastroparesis Due to Diabetes Mellitus Type II Functional Disorder of Gastrointestinal Tract Gastro-Intestinal Disorder

Detailed Description:

This observational study of patients with symptoms of gastroparesis (Gp) and functional dyspepsia (FD) with either delayed or normal gastric emptying aims to assess the clinical, pathophysiological, and psychological similarities and differences between patients with Gp, FD.

The primary outcome will be the measure of symptom severity of gastroparesis and functional dyspepsia using the change in total score from the Patient Assessment of Upper Gastrointestinal Disorders Symptoms (PAGI SYM) from baseline to 48 weeks.

Study Design
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Study Type : Observational
Estimated Enrollment : 250 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Gastroparesis Registry 4 (GpR4): Improving the Understanding of Gastroparesis and Functional Dyspepsia
Estimated Study Start Date : June 15, 2024
Estimated Primary Completion Date : August 2026
Estimated Study Completion Date : July 2027

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Indigestion

Groups and Cohorts
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Group/Cohort
Gastroparesis
Gastroparesis symptoms with delayed emptying
Functional Dyspepsia
Gastroparesis symptoms without delayed emptying


Outcome Measures
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Primary Outcome Measures :
  1. Measure of symptom severity of gastroparesis and functional dyspepsia using the change in total score from the Patient Assessment of Upper Gastrointestinal Disorders Symptoms (PAGI SYM) from baseline to 48 weeks. [ Time Frame: 48 weeks ]

    Change in PAGI-SYM total score from baseline to 48 weeks. The final PAGI-SYM contains 20 items grouped into 6 subscales covering:

    heartburn/regurgitation (7 items), nausea/vomiting (3 items), post-prandial fullness/early satiety (4 items), bloating (2 items), upper abdominal pain (2 items), and lower abdominal pain (2 items). A 6-point Likert response scale, ranging from 0 (none) to 5 (very severe), is used for rating the severity of each symptom item over a 2-week recall period.

    • Subscale scores vary from 0 to 5
    • Total score varies from 0 to 5
    • Lower score = better health


Secondary Outcome Measures :
  1. Changes in gastric emptying, as measured by gastric emptying scintigraphy (GES) at baseline and 48 weeks [ Time Frame: Baseline, 48 weeks ]

    Changes in gastric emptying, as measured by gastric emptying scintigraphy (GES) at baseline and 48 weeks.

    Normal values for gastric emptying scintigraphy have been established in earlier studies using healthy volunteers. Gastric retention of 99mTc > 60% at 2 hours and/or > 10% at 4 hours is considered evidence of delayed gastric emptying of solids.



Other Outcome Measures:
  1. Presence or absence of Carnett's sign for abdominal wall pain at baseline. [ Time Frame: Baseline ]

    Presence or absence Carnett's sign for abdominal wall pain at baseline. Carnett's sign is a finding on clinical examination in which (acute) abdominal pain remains unchanged or increases when the muscles of the abdominal wall are tensed. As part of the abdominal examination, the patient is asked to lift the head and shoulders from the examination table to tense the abdominal muscles. An alternative is to ask the patient to raise both legs with straight knees.

    A positive test indicates the increased likelihood that the abdominal wall and not the abdominal cavity is the source of the pain (for example, due to rectus sheath hematoma instead of appendicitis). A negative Carnett's sign is said to occur when the abdominal pain decreases when the patient is asked to lift the head; this points to an intra-abdominal cause of the pain



Biospecimen Retention:   Samples Without DNA
20 mL of fasting blood collected and will be separated into plasma and serum and divided into 0.5 mL aliquots. Aliquots will be kept in a storage facility at -70 degrees C until they are shipped to the NIDDK Central Repository on dry ice for banking. The banked samples will be used for specific GpR4 research questions, GpCRC ancillary studies,and future health-related research..

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adults over age 18, located in the United States, with symptoms of gastroparesis and/or functional dyspepsia.
Criteria

Inclusion Criteria:

  • Age at least 18 years at initial screening visit
  • Symptoms of Gp and/or FD of at least 12-weeks duration with varying degrees of nausea, vomiting, early satiety, postprandial fullness, abdominal pain, abdominal burning. Thus, patients can enter the GpR4 registry primarily with abdominal pain suggesting FD-Epigastric Pain Syndrome.
  • Successful completion of gastric emptying scintigraphy of solids using the 4-hour Egg Beaters® protocol (or equivalent generic liquid egg white meal) within the last 6 months
  • Negative upper endoscopy or upper radiographic GI series within 2 years of registration

Exclusion Criteria:

  • Use of narcotic analgesics greater than three days per week
  • Presence of other conditions that could explain the patient's symptoms such as:
  • Pyloric or intestinal obstruction as evidenced 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 or chronic renal failure (serum creatinine >3 mg/dL) and/or on hemodialysis or peritoneal dialysis
  • Acute liver failure or advanced liver disease (Child's B or C; a Child-Pugh-Turcotte (CPT) score of ≥7)
  • Pancreatic disorder if present on pancreatic imaging or pancreatic function testing
  • Prior gastric surgery including total or subtotal (near complete) gastric resection, esophagectomy, gastrojejunostomy, gastric bypass, gastric sleeve, pyloroplasty, pyloromyotomy, or any fundoplication (Nissen, Tor)
  • Any other condition, which in the opinion of the investigator, could explain the symptoms or interfere with study requirements
  • Females who are pregnant. A urine pregnancy test is routinely obtained on all females immediately prior to gastric emptying procedures.
  • Inability to comply with or complete the gastric emptying scintigraphy test (including allergy to eggs)
  • Inability to obtain informed consent
Contacts and Locations
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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): NCT05846802


Contacts
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Contact: Laura Miriel 4435024165 lmiriel1@jhu.edu
Contact: Emily Mitchell, MS, MBA esharke5@jhu.edu

Locations
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United States, Arizona
Jay Pasricha
Scottsdale, Arizona, United States, 85259
United States, Kentucky
University of Louisville
Louisville, Kentucky, United States, 40202
Contact: Thomas Abell, MD    502-852-7963    thomas.abell@louisville.edu   
Contact: Bridget Cannon    (502) 540-1428    Bridget.cannon@louisville.edu   
Principal Investigator: Thomas L Abell, MD         
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Contact: Braden L Kuo, MD    617-726-0196    bkuo@partners.org   
Contact: Rebecca Karlson       RKARLSON@mgh.harvard.edu   
Principal Investigator: Braden Kuo, MD         
United States, North Carolina
Wake Forest University and Atrium Health Carolinas Medical Center
Charlotte, North Carolina, United States, 28202
Contact: Baha Moshiree, MD    704-355-4593    Baha.Moshiree@atriumhealth.org   
Contact: Yolanda Levy    (704) 667-05820    Yolanda.Levy@atriumhealth.org   
Principal Investigator: Baha Moshiree, MD         
United States, Pennsylvania
Temple University Hospital
Philadelphia, Pennsylvania, United States, 19140
Contact: Henry Parkman, MD    215-707-7579    henry.parkman@temple.edu   
Contact: Rona T Cooper    2157075477    rona.taylor@temple.edu   
Principal Investigator: Henry Parkman, MD         
United States, Texas
Texas Tech University Health Science Center (TTUHSC)
El Paso, Texas, United States, 79905
Contact: Irene Sarosiek, MD    915-545-6626 ext 230    irene.sarosiek@ttuhsc.edu   
Contact: Denise Vasquez    (915) 214-4388    denise.vasquez@ttuhsc.edu   
Principal Investigator: Richard McCallum, MD         
Principal Investigator: Irene Sarosiek         
Sponsors and Collaborators
Johns Hopkins Bloomberg School of Public Health
Texas Tech University Health Sciences Center, El Paso
Temple University
University of Louisville
Mayo Clinic
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Massachusetts General Hospital
Wake Forest University
Investigators
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Principal Investigator: Jay Pasricha, MD Mayo Clinic
Principal Investigator: Henry Parkman, MD Temple University
Principal Investigator: James Tonascia, PhD Johns Hopkins Bloomberg School of Public Health
More Information
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Publications:

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Responsible Party: Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier: NCT05846802    
Other Study ID Numbers: 14-DK-GpR4
U01DK073975 ( U.S. NIH Grant/Contract )
U01DK074035 ( U.S. NIH Grant/Contract )
U01DK074007 ( U.S. NIH Grant/Contract )
U24DK074008 ( U.S. NIH Grant/Contract )
U01DK073983 ( U.S. NIH Grant/Contract )
U01DK112193 ( U.S. NIH Grant/Contract )
U01DK073974 ( U.S. NIH Grant/Contract )
IRB00401119 ( Other Identifier: JHM IRB )
First Posted: May 6, 2023    Key Record Dates
Last Update Posted: May 9, 2024
Last Verified: May 2024
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
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Analytic Code
Time Frame: Two years after the end of the funding period ends (2029)
Access Criteria: An investigator interested in acquiring GpR4 study data or biospecimens should contact the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Central Repository
URL: https://repository.niddk.nih.gov/home/

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Gastroparesis
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Diabetes Mellitus
Diabetes Mellitus, Type 2
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
 Metabolic Diseases
Endocrine System Diseases
Stomach Diseases
Paralysis
Neurologic Manifestations
Autoimmune Diseases
Immune System Diseases