Gastroparesis Registry 2

Trial ID or NCT#

NCT01696747

Status

not recruiting iconNOT RECRUITING

Purpose

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

Official Title

GpR 2: Continuation of the NIDDK Gastroparesis Registry for the Characterization and Clinical Course of Gastroparesis Patients

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. * 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:
  2. * 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
Exclusion Criteria:
  1. * 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
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Investigator(s)

Linda Nguyen
Linda Nguyen
Gastroenterologist, Motility specialist
Clinical Professor, Medicine - Gastroenterology & Hepatology

Contact us to find out if this trial is right for you.

Contact

Linda Nguyen, MD
650-725-3362

View on ClinicalTrials.gov