Two hundred ninety-nine patients with diabetic or idiopathic gastroparesis were recruited by the six centers of the NIH Gastroparesis Clinical Research Consortium into a multicenter Gastroparesis Registry from January 2007 through August 2009 (ClinicalTrials.gov Identifier: NCT00398801). To be eligible for Registry enrollment, subjects at least 18 years of age must have experienced symptoms of gastroparesis for ≥12 weeks that were not necessarily contiguous, with varying degrees of nausea, vomiting, abdominal pain, early satiety, and postprandial fullness. All subjects completed a 4-h gastric scintiscan using a standardized low fat meal within 6 months of Registry enrollment (16 (link)). For this investigation, all patients exhibited delayed emptying with >10% meal retention at 4h and/or >60% retention at 2h. Exclusion criteria included the presence of other conditions potentially explanatory of symptoms (e.g., mechanical obstruction, active inflammatory bowel disease, eosinophilic gastroenteritis, neurologic disease, acute liver or kidney disease); and prior fundoplication, gastric resection or pyloroplasty; and normal gastric scintigraphy values at 2 and 4 h.
The Gastroparesis Registry protocol and consent statements were approved by the institutional review board at each clinical center and at the data coordinating center. Written informed consent statements were obtained from all Registry participants before enrollment in the study.
The Gastroparesis Registry protocol and consent statements were approved by the institutional review board at each clinical center and at the data coordinating center. Written informed consent statements were obtained from all Registry participants before enrollment in the study.
