Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
591 participants
OBSERVATIONAL
2006-12-31
2011-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* Completion of a 4-hour scintigraphic low fat Egg Beaters gastric emptying study
* Patients with either or both abnormal 2 hour (\>60% retention) and 4 hour (\>10% retention) gastric emptying will be enrolled and classified as definite gastroparesis (Gp)
* Patients with normal gastric emptying, but with symptoms of gastroparesis may be enrolled and classified as possible gastroparesis or gastroparesis-like with normal gastric emptying (GLNGE)
* Age at least 18 years at initial screening visit
* Ability and willingness to participate in follow-up
Exclusion Criteria
* Presence of other conditions that could explain the patient's symptoms:
* Pyloric or intestinal obstruction
* Active inflammatory bowel disease
* Eosinophilic gastroenteritis
* Neurological conditions such as increased intracranial pressure, space occupying or inflammatory/infectious lesions
* Acute liver failure
* Advanced liver disease (Child's B or C)
* Acute renal failure
* Untreated chronic renal failure (serum creatinine \>3 mg/dL)
* Total or subtotal gastric resection (patients with prior fundoplication or postvagotomy gastroparesis after pyloroplasty or antrectomy with Billroth I, Billroth II, or Roux-en-Y gastrojejunostomy 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
18 Years
ALL
No
Sponsors
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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
Johns Hopkins Bloomberg School of Public Health
OTHER
Responsible Party
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Principal Investigators
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James Tonascia, PhD
Role: PRINCIPAL_INVESTIGATOR
Johns Hopkins University Bloomberg School of Public Health
Henry P Parkman, MD
Role: PRINCIPAL_INVESTIGATOR
Temple University Hospital
William L Hasler, MD
Role: PRINCIPAL_INVESTIGATOR
University of Michigan
Thomas L Abell, MD
Role: PRINCIPAL_INVESTIGATOR
University of Mississippi Medical Center
Pankaj J Pasricha, MD
Role: PRINCIPAL_INVESTIGATOR
Stanford University
Kenneth L Koch, MD
Role: PRINCIPAL_INVESTIGATOR
Wake Forest University Health Sciences
Richard W McCallum, MD
Role: PRINCIPAL_INVESTIGATOR
Texas Tech University Health Science Center
Locations
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California Pacific Medical Center
San Francisco, California, United States
Stanford University
Stanford, California, United States
University of Michigan Medical Center
Ann Arbor, Michigan, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
Temple University Hospital
Philadelphia, Pennsylvania, United States
Texas Tech University Health Science Center (TTUHSC)
El Paso, Texas, United States
Countries
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References
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Parkman HP, Yates K, Hasler WL, Nguyen L, Pasricha PJ, Snape WJ, Farrugia G, Koch KL, Calles J, Abell TL, Sarosiek I, McCallum RW, Lee L, Unalp-Arida A, Tonascia J, Hamilton F. Cholecystectomy and clinical presentations of gastroparesis. Dig Dis Sci. 2013 Apr;58(4):1062-73. doi: 10.1007/s10620-013-2596-y. Epub 2013 Mar 2.
Sarosiek I, Van Natta M, Parkman HP, Abell T, Koch KL, Kuo B, Shulman RJ, Farrugia G, Grover M, Hamilton FA, Pasricha PJ, Yates KP, Miriel L, Wilson L, Yamada G, Tonascia J, McCallum RW; National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Gastroparesis Clinical Research Consortium (GpCRC). Effect of Domperidone Therapy on Gastroparesis Symptoms: Results of a Dynamic Cohort Study by NIDDK Gastroparesis Consortium. Clin Gastroenterol Hepatol. 2022 Mar;20(3):e452-e464. doi: 10.1016/j.cgh.2021.05.063. Epub 2021 Jun 2.
Pasricha PJ, Grover M, Yates KP, Abell TL, Bernard CE, Koch KL, McCallum RW, Sarosiek I, Kuo B, Bulat R, Chen J, Shulman RJ, Lee L, Tonascia J, Miriel LA, Hamilton F, Farrugia G, Parkman HP; National Institute of Diabetes and Digestive and Kidney Diseases/National Institutes of Health Gastroparesis Clinical Research Consortium. Functional Dyspepsia and Gastroparesis in Tertiary Care are Interchangeable Syndromes With Common Clinical and Pathologic Features. Gastroenterology. 2021 May;160(6):2006-2017. doi: 10.1053/j.gastro.2021.01.230. Epub 2021 Feb 3.
Parkman HP, Wilson LA, Yates KP, Koch KL, Abell TL, McCallum RW, Sarosiek I, Kuo B, Malik Z, Schey R, Shulman RJ, Grover M, Farrugia G, Miriel L, Tonascia J, Hamilton F, Pasricha PJ; NIDDK/NIH Clinical Gastroparesis Consortium. Factors that contribute to the impairment of quality of life in gastroparesis. Neurogastroenterol Motil. 2021 Aug;33(8):e14087. doi: 10.1111/nmo.14087. Epub 2021 Jan 25.
Pasricha PJ, Yates KP, Nguyen L, Clarke J, Abell TL, Farrugia G, Hasler WL, Koch KL, Snape WJ, McCallum RW, Sarosiek I, Tonascia J, Miriel LA, Lee L, Hamilton F, Parkman HP. Outcomes and Factors Associated With Reduced Symptoms in Patients With Gastroparesis. Gastroenterology. 2015 Dec;149(7):1762-1774.e4. doi: 10.1053/j.gastro.2015.08.008. Epub 2015 Aug 21.
Parkman HP, Yates K, Hasler WL, Nguyen L, Pasricha PJ, Snape WJ, Farrugia G, Koch KL, Abell TL, McCallum RW, Lee L, Unalp-Arida A, Tonascia J, Hamilton F; National Institute of Diabetes and Digestive and Kidney Diseases Gastroparesis Clinical Research Consortium. Clinical features of idiopathic gastroparesis vary with sex, body mass, symptom onset, delay in gastric emptying, and gastroparesis severity. Gastroenterology. 2011 Jan;140(1):101-15. doi: 10.1053/j.gastro.2010.10.015. Epub 2010 Oct 20.
Related Links
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National Institute of Diabetes and Digestive and Kidney Diseases
Gastroparesis Clinical Research Consortium
Other Identifiers
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U01DK074008 GpR
Identifier Type: -
Identifier Source: org_study_id
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