Gastroparesis Registry - Full Text View

Sponsor:	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by:	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:	NCT00398801

Purpose

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

Condition
Gastroparesis

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	Gastroparesis Registry

Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Biospecimen Retention: Samples With DNA

Plasma and serum

Estimated Enrollment:	500
Study Start Date:	December 2006
Estimated Study Completion Date:	March 2011
Estimated Primary Completion Date:	March 2010 (Final data collection date for primary outcome measure)

Detailed Description:

The Gastroparesis Registry (GpR) is an observational study to clarify the epidemiology, natural history, clinical course, and other outcomes of gastroparesis. The Gastroparesis Registry will also provide a resource to inform the development of clinical trials and ancillary studies of the epidemiology, etiology, pathophysiology, and impact of gastroparesis.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Tertiary care centers for patients with symptoms of gastroparesis

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00398801

Locations

United States, California
California Pacific Medical Center
San Francisco, California, United States, 94115
Stanford University
Stanford, California, United States, 94305-5187
United States, Michigan
University of Michigan Medical Center
Ann Arbor, Michigan, United States, 48109
United States, Mississippi
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216
United States, North Carolina
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
United States, Pennsylvania
Temple University Hospital
Philadelphia, Pennsylvania, United States, 19140
United States, Texas
Texas Tech University Health Science Center (TTUHSC)
El Paso, Texas, United States, 79905

Sponsors and Collaborators

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

Investigators

Principal Investigator:	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
Principal Investigator:	Richard W McCallum, MD	Texas Tech University Health Science Center

More Information

Additional Information:

National Institute of Diabetes and Digestive and Kidney Diseases This link exits the ClinicalTrials.gov site

Gastroparesis Clinical Research Consortium This link exits the ClinicalTrials.gov site

No publications provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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. Epub 2010 Oct 20.

Responsible Party:	Frank Hamilton, PhD, National Institute of Diabetes and Digestive and Kidney Diseases
ClinicalTrials.gov Identifier:	NCT00398801 History of Changes
Other Study ID Numbers:	IND - DK74008
Study First Received:	November 13, 2006
Last Updated:	February 3, 2011
Health Authority:	United States: Federal Government

Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

gastroparesis

Additional relevant MeSH terms:

Gastroparesis
Stomach Diseases
Gastrointestinal Diseases
Digestive System Diseases

Paralysis
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on May 24, 2012