Gastroparesis Registry 3

NCT03680859 | Completed DMC

• 8 other identifiers: 7 DK GpR3U01DK073983U01DK112193U01DK073975U01DK074035U01DK074007U01DK073974U24DK074008
• Study Type: observational
• Target: 406
• Locations: 1 country
• Sites: 6

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.

Conditions

Gastroparesis; Diabetic Gastroparesis; Idiopathic Gastroparesis

Outcome Measures

Primary Outcomes (1)

• Change from baseline GSCI score at 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.

  Baseline to 48 weeks

Secondary Outcomes (2)

• Change from baseline in Short Form Health Survey (SF-36v2) physical health QOL component score at 48 weeks

  Baseline to 48 weeks

• Change from baseline in Short Form Health Survey (SF-36v2) mental health QOL component score at 48 weeks

  Baseline to 48 weeks

Study Arms (6)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins Bloomberg School of Public Health: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator
• Johns Hopkins University: collaborator
• Massachusetts General Hospital: collaborator
• Temple University: collaborator
• University of Louisville: collaborator
• Wake Forest University: collaborator
• Texas Tech University Health Sciences Center, El Paso: collaborator

Study Sites (6)

University of Louisville

Louisville, Kentucky, 40202, United States

Location

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, 21224, United States

Location

Massachusetts General Hospital-Digestive Healthcare Center

Boston, Massachusetts, 02114, United States

Location

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

Temple University Hospital

Philadelphia, Pennsylvania, 19140, United States

Location

Texas Tech University Health Science Center (TTUHSC)

El Paso, Texas, 79905, United States

Location

Related Links

• Gastroparesis Clinical Research Consortium

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma, serum, and PBMC specimens

MeSH Terms

Conditions

Gastroparesis

Condition Hierarchy (Ancestors)

Stomach Diseases; Gastrointestinal Diseases; Digestive System Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Henry Parkman, MD

  Temple University Hospital

  STUDY CHAIR

• Braden Kuo, MD

  Massachusetts General Hospital

  STUDY CHAIR

• Pankaj J Pasricha, MD

  Johns Hopkins University

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2018
• First Posted: September 21, 2018
• Study Start: January 24, 2019
• Primary Completion: May 13, 2024
• Study Completion: May 13, 2024
• Last Updated: May 24, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Two years after the end of the funding period
• Access Criteria: An investigator interested in acquiring GpR3 study data should contact the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Central Repository at https://www.niddkrepository.org/search/study/ and apply to obtain the data required for their study. IRB approval

Locations

US (6)