Gastroparesis Registry

NCT00398801 | Completed DMC

• 2 other identifiers: U01DK074008 GpRU01DK074008
• Study Type: observational
• Target: 591
• Locations: 1 country
• Sites: 7

Brief Summary

The Gastroparesis Registry (GpR) is an observational study to clarify the epidemiology, natural history, clinical course, and other outcomes of gastroparesis.

Conditions

Gastroparesis

Keywords

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

Tertiary care centers for patients with symptoms of gastroparesis

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, abdominal pain, early satiety, post-prandial fullness,
• 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

You may not qualify if:

• Inability to comply with or complete the gastric emptying scintigraphy
• 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

Sponsors & Collaborators

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

Study Sites (7)

California Pacific Medical Center

San Francisco, California, 94115, United States

Location

Stanford University

Stanford, California, 94305-5187, United States

Location

University of Michigan Medical Center

Ann Arbor, Michigan, 48109, United States

Location

University of Mississippi Medical Center

Jackson, Mississippi, 39216, 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 Publications (6)

• 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.

  PMID: 23456496 RESULT

• 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

• 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.

  PMID: 26299414 DERIVED

• 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.

  PMID: 20965184 DERIVED

Related Links

• National Institute of Diabetes and Digestive and Kidney Diseases
• Gastroparesis Clinical Research Consortium

Biospecimen

Retention: SAMPLES WITH DNA

Plasma and serum

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

• James Tonascia, PhD

  Johns Hopkins University Bloomberg School of Public Health

  PRINCIPAL INVESTIGATOR

• Henry P Parkman, MD

  Temple University Hospital

  PRINCIPAL INVESTIGATOR

• William L Hasler, MD

  University of Michigan

  PRINCIPAL INVESTIGATOR

• Thomas L Abell, MD

  University of Mississippi Medical Center

  PRINCIPAL INVESTIGATOR

• Pankaj J Pasricha, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

• Kenneth L Koch, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

• Richard W McCallum, MD

  Texas Tech University Health Science Center

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: November 13, 2006
• First Posted: November 14, 2006
• Study Start: December 1, 2006
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2011
• Last Updated: February 23, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Data deposited 05Jul2016
• Access Criteria: Registered user of NIDDK Central Repository

Locations

US (7)