Gastroparesis Registry 2

NCT01696747 | Completed DMC

• 7 other identifiers: GpCRC-GpR 2-5U01DK073974U01DK073975U01DK073983U01DK073985U01DK074007U01DK074008
• Study Type: observational
• Target: 506
• Locations: 1 country
• Sites: 6

Brief Summary

To expand a registry of patients for the study of the epidemiology, etiology, and degree of morbidity associated with gastroparesis.

Conditions

Gastroparesis; Diabetic Gastroparesis; Idiopathic Gastroparesis

Keywords

gastroparesis; idiopathic gastroparesis; diabetic gastroparesis; post-Nissen gastroparesis

Study Arms (3)

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

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

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins Bloomberg School of Public Health: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): 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 Sciences Center

El Paso, Texas, 79905, United States

Location

Related Publications (13)

• Parkman HP, Van Natta ML, Maurer AH, Koch KL, Grover M, Malik Z, Sarosiek I, Abell TL, Bulat R, Kuo B, Shulman RJ, Farrugia G, Miriel L, Tonascia J, Hamilton F, Pasricha PJ, McCallum RW. Postprandial symptoms in patients with symptoms of gastroparesis: roles of gastric emptying and accommodation. Am J Physiol Gastrointest Liver Physiol. 2022 Jul 1;323(1):G44-G59. doi: 10.1152/ajpgi.00278.2021. Epub 2022 May 3.

  PMID: 35502871 DERIVED

• Parkman HP, Van Natta ML, Makol A, Grover M, McCallum RW, Malik Z, Koch KL, Sarosiek I, Kuo B, Shulman RJ, Farrugia G, Miriel L, Tonascia J, Hamilton F, Pasricha PJ, Abell TL; NIDDK Gastroparesis Clinical Research Consortium. Prevalence and clinical correlates of antinuclear antibody in patients with gastroparesis. Neurogastroenterol Motil. 2022 May;34(5):e14270. doi: 10.1111/nmo.14270. Epub 2021 Oct 1.

  PMID: 34595805 DERIVED

• 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.

  PMID: 34089855 DERIVED

• 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.

  PMID: 33548234 DERIVED

• 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.

  PMID: 33493377 DERIVED

• Parkman HP, Sharkey E, McCallum RW, Hasler WL, Koch KL, Sarosiek I, Abell TL, Kuo B, Shulman RJ, Grover M, Farrugia G, Schey R, Tonascia J, Hamilton F, Pasricha PJ; NIH/NIDDK Gastroparesis Consortium. Constipation in Patients With Symptoms of Gastroparesis: Analysis of Symptoms and Gastrointestinal Transit. Clin Gastroenterol Hepatol. 2022 Mar;20(3):546-558.e5. doi: 10.1016/j.cgh.2020.10.045. Epub 2020 Oct 28.

  PMID: 33130007 DERIVED

• Parkman HP, Van Natta M, Yamada G, Grover M, McCallum RW, Sarosiek I, Farrugia G, Koch KL, Abell TL, Kuo B, Miriel L, Tonascia J, Hamilton F, Pasricha PJ. Body weight in patients with idiopathic gastroparesis. Neurogastroenterol Motil. 2021 Feb;33(2):e13974. doi: 10.1111/nmo.13974. Epub 2020 Sep 15.

  PMID: 32930463 DERIVED

• Parkman HP, Sharkey EP, Nguyen LA, Yates KP, Abell TL, Hasler WL, Snape W, Clarke J, Schey R, Koch KL, Kuo B, McCallum RW, Sarosiek I, Grover M, Farrugia G, Tonascia J, Pasricha PJ; Frank A. Hamilton for the NIH Gastroparesis Consortium. Marijuana Use in Patients with Symptoms of Gastroparesis: Prevalence, Patient Characteristics, and Perceived Benefit. Dig Dis Sci. 2020 Aug;65(8):2311-2320. doi: 10.1007/s10620-019-05963-2. Epub 2019 Nov 22.

  PMID: 31758430 DERIVED

• Parkman HP, Wilson LA, Hasler WL, McCallum RW, Sarosiek I, Koch KL, Abell TL, Schey R, Kuo B, Snape WJ, Nguyen L, Farrugia G, Grover M, Clarke J, Miriel L, Tonascia J, Hamilton F, Pasricha PJ. Abdominal Pain in Patients with Gastroparesis: Associations with Gastroparesis Symptoms, Etiology of Gastroparesis, Gastric Emptying, Somatization, and Quality of Life. Dig Dis Sci. 2019 Aug;64(8):2242-2255. doi: 10.1007/s10620-019-05522-9. Epub 2019 Mar 9.

  PMID: 30852767 DERIVED

• Parkman HP, Yamada G, Van Natta ML, Yates K, Hasler WL, Sarosiek I, Grover M, Schey R, Abell TL, Koch KL, Kuo B, Clarke J, Farrugia G, Nguyen L, Snape WJ, Miriel L, Tonascia J, Hamilton F, Pasricha PJ, McCallum RW. Ethnic, Racial, and Sex Differences in Etiology, Symptoms, Treatment, and Symptom Outcomes of Patients With Gastroparesis. Clin Gastroenterol Hepatol. 2019 Jul;17(8):1489-1499.e8. doi: 10.1016/j.cgh.2018.10.050. Epub 2018 Nov 4.

  PMID: 30404035 DERIVED

• Siraj ES, Homko C, Wilson LA, May P, Rao AD, Calles J, Farrugia G, Hasler WL, Koch KL, Nguyen L, Snape WJ, Abell TL, Sarosiek I, McCallum RW, Pasricha PJ, Clarke J, Tonascia J, Hamilton F, Parkman HP. Islet Cell Associated Autoantibodies and C-Peptide Levels in Patients with Diabetes and Symptoms of Gastroparesis. Front Endocrinol (Lausanne). 2018 Feb 13;9:32. doi: 10.3389/fendo.2018.00032. eCollection 2018.

  PMID: 29487566 DERIVED

• Orthey P, Yu D, Van Natta ML, Ramsey FV, Diaz JR, Bennett PA, Iagaru AH, Fragomeni RS, McCallum RW, Sarosiek I, Hasler WL, Farrugia G, Grover M, Koch KL, Nguyen L, Snape WJ, Abell TL, Pasricha PJ, Tonascia J, Hamilton F, Parkman HP, Maurer AH; NIH Gastroparesis Consortium. Intragastric Meal Distribution During Gastric Emptying Scintigraphy for Assessment of Fundic Accommodation: Correlation with Symptoms of Gastroparesis. J Nucl Med. 2018 Apr;59(4):691-697. doi: 10.2967/jnumed.117.197053. Epub 2017 Sep 28.

  PMID: 28970332 DERIVED

• Parkman HP, Hallinan EK, Hasler WL, Farrugia G, Koch KL, Nguyen L, Snape WJ, Abell TL, McCallum RW, Sarosiek I, Pasricha PJ, Clarke J, Miriel L, Tonascia J, Hamilton F; NIDDK Gastroparesis Clinical Research Consortium (GpCRC). Early satiety and postprandial fullness in gastroparesis correlate with gastroparesis severity, gastric emptying, and water load testing. Neurogastroenterol Motil. 2017 Apr;29(4):10.1111/nmo.12981. doi: 10.1111/nmo.12981. Epub 2016 Oct 25.

  PMID: 27781342 DERIVED

Related Links

• Gastroparesis Clinical Research Consortium

Biospecimen

Retention: SAMPLES WITH DNA

plasma serum DNA

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

• Frank Hamilton, MD, MPH

  National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: September 27, 2012
• First Posted: October 1, 2012
• Study Start: July 1, 2012
• Primary Completion: April 30, 2019
• Study Completion: April 30, 2019
• Last Updated: February 23, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will share

Locations

US (6)