The NIDDK Disorders of Gastrointestinal Interoception Consortium Clinical Centers (DGIC)
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The contract involves the continuation and expansion of research efforts by the National Institute of Diabetes and Digestive Diseases and Nutrition (NIDDK) related to gastrointestinal (GI) disorders. Building upon the NIDDK Gastroparesis Consortium (GpCRC), which established a comprehensive patient registry and advanced understanding of gastroparesis, this initiative seeks to broaden its focus to include a wider range of adult and pediatric GI conditions linked to impaired interoceptive processing—the nervous system's ability to interpret internal bodily signals. This expanded program, known as the Disorders of Gastrointestinal Interoception Consortium (DGIC), aims to form a collaborative network consisting of up to six Clinical Research Centers and a Scientific Data Research Center (SDRC). The consortium will emphasize multidisciplinary research designed to elucidate the mechanisms connecting GI function to symptoms, identify biomarkers for disease and treatment response, and utilize advanced technologies to uncover new therapeutic targets. The SDRC will play a central role in managing collaboration among the research centers, overseeing participant enrollment, handling biospecimen collection and processing, and coordinating data and sample submissions to centralized repositories. The overall goal is to enhance the scientific understanding of GI disorders through coordinated clinical studies and data integration, ultimately facilitating the development of improved therapeutic approaches. This effort underscores a commitment to addressing the complex clinical burden of GI disorders beyond gastroparesis, reflecting recent findings that indicate a broader and more intricate pathophysiology involving interoception.
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The National Institute of Diabetes and Digestive Diseases and Nutrition (NIDDK) seeks to advance its mission by continuing the work of the NIDDK Gastroparesis Consortium (GpCRC) but also to expand its scope. The collaborative efforts of the GpCRC provided a large database, the Gastroparesis Registry, which is located in the NIDDK central repository and contains information on patients with symptoms of either delayed or normal gastric emptying. It also houses the first U.S. registry of children and adolescents with gastroparesis. The GpCRC provided clarity and insight that set the stage for transforming our understanding of gastroparesis and laid out a road map for approaching other disorders of gastrointestinal (GI) motility. The findings from clinical studies and trials clearly demonstrated that the clinical burden of gastroparesis is significantly greater than previously realized and involves much more than the stomach. Importantly, the underlying mechanisms remain unclear.
Interoception is the ability of the nervous system to sense, interpret and coordinate signals from various bodily systems including the GI tract. Many functional GI disorders are associated with a spectrum of overlapping symptoms including nausea, vomiting, and altered bowel habits all of which involve altered interoceptive signaling. This initiative would broaden the scope beyond gastroparesis to include other adult and pediatric GI conditions associated with impaired interoceptive processing to form a Disorders of Gastrointestinal Interoception Consortium (DGIC). The consortium may include up to 6 Clinical Research Centers (described in a companion notice) and a Scientific Data Research Center (SDRC). There would be an emphasis on multidisciplinary approaches that would reveal the underlying mechanisms that connect GI function more directly to symptoms, identify disease or response biomarkers that assess treatment efficacy, and leverage state-of-the-art technologies to identify novel therapeutic targets that could be assessed in future clinical trials. The SDRC will coordinate collaboration among the Clinical Research Centers, participant enrollment, biospecimen collections and processing, and manage the submission of data and samples to central databases and repositories.