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Gastroparesis, a syndrome in which patients experience delayed emptying of the stomach, is characterized by symptoms such as nausea, vomiting, bloating, abdominal pain, and early satiety. While the incidence and prevalence of gastroparesis are not well-defined, the condition is estimated to affect up to 5 million individuals in the US. Research progress on this syndrome has been hindered by challenges such as single centers, small population base, and limited range of clinical and research techniques available to study. In response to these limitations, the Gastroparesis Clinical Research Consortium (GpCRC) was established by the NIDDK to advance research on the etiology, natural history, and therapy of gastroparesis. Specific aims of the consortium include providing an infrastructure for the efficient design and conduct of multicenter clinical studies; performing clinical trials to investigate clinical, diagnostic, and therapeutic interventions for gastroparesis; and creating a collection of patient samples that may be used for ancillary studies of etiology and pathogenesis.
Clinical trials conducted by the GpCRC include Aprepitant for the Relief of Nausea in Patients with Chronic Nausea and Vomiting of Presumed Gastric Origin (APRON), Continuous Glucose Monitoring and Insulin Pump Therapy in Diabetic Gastroparesis (GLUMIT), and Nortriptyline for Idiopathic Gastroparesis (NORIG). The NORIG and GLUMIT studies have now been completed. The GpCRC has also successfully established a registry of individuals with gastroparesis to study to clarify the epidemiology, natural history, clinical course, and other outcomes of the condition (GpR) and to provide a resource for ancillary studies. Expansion of the registry is currently ongoing. More details about these studies, including information on enrollment, methods, and outcomes, are available on the individual study pages on the NIDDK Repository site.
The overall objectives of the GpCRC include providing an infrastructure for the efficient design and conduct of multicenter clinical studies; performing clinical trials to investigate clinical, diagnostic, and therapeutic interventions for gastroparesis; and creating a collection of patient samples that may be used for ancillary studies of etiology and pathogenesis. Ultimately, it is hoped that this research will improve the diagnosis and treatment of patients with gastroparesis.
The GpCRC has successfully created a registry of patients with gastroparesis (GpR) and has established clinical trials to investigate therapies for this condition (APRON, GLUMIT, NORIG). The NORIG and GLUMIT studies have been completed. More details about these studies, including information on enrollment, methods, and outcomes, are available on the individual study pages on the NIDDK Repository site.
