Gastroparesis, a syndrome in which patients experience delayed gastric emptying, is characterized by symptoms such as nausea, vomiting, bloating, abdominal pain, and early satiety. While gastroparesis can present as a complication of diabetes and gastric surgery, the underlying cause is unknown in many cases. Despite the significant morbidity of the condition, research and characterization of the clinical features of gastroparesis are limited, hindered by challenges such as single centers and small study populations. The Gastroparesis Registry is an observational study created by the Gastroparesis Clinical Research Consortium (GpCRC) to enroll a sufficiently large number of patients to elucidate the etiology and clinical features of the condition.
Individuals with symptoms of gastroparesis of at least 12 weeks duration, delayed gastric emptying on scintigraphy, and no abnormality causing obstruction on upper endoscopy were enrolled. Data was collected on medical history, physical examinations, upper endoscopy results, and 4 hour gastric emptying scintigraphy results. Symptoms of gastroparesis and psychological functioning were assessed using patient-completed questionnaires, including the Patient Assessment of Upper Gastrointestinal Disorders Symptoms Severity Index (PAGI-SYM), the Beck Depression Inventory (BDI), and the State-Trait Anxiety Inventory (STAI). Laboratory tests were obtained to measure complete blood count with erythrocyte sedimentation rate (ESR) and C reactive protein (CRP).
Analyses were done to examine such baseline characteristics as demographics, lifestyle, co-morbidities, laboratory values, psychological evaluation test scores, gastroparesis-specific medical history, gastric emptying scintigraphy results, and symptom severity among all patients and among various patient sub-groups. Comparisons were also done to evaluate the similarities and differences of the diabetic and idiopathic presentations of gastroparesis. Results showed that IG is a diverse syndrome that varies by sex, body mass, symptom onset, and delay in gastric emptying. Following conclusion of the GpR study, a follow-up study was initiated to expand the registry (GpR 2).
The primary objectives of the study included investigating the etiology of gastroparesis and elucidating the clinical features and outcomes of the condition.
Individuals of at least 18 years of age who met the following criteria were eligible for enrollment:
Exclusion criteria are documented in the study protocol.
Analyses were done to examine such baseline characteristics as demographics, lifestyle, co-morbidities, laboratory values, psychological evaluation test scores, gastroparesis-specific medical history, gastric emptying scintigraphy results, and symptom severity among all patients and among various patient sub-groups. Comparisons were also done to evaluate the similarities and differences of the diabetic and idiopathic presentations of gastroparesis. Results showed that IG is a diverse syndrome that varies by sex, body mass, symptom onset, and delay in gastric emptying. Following conclusion of the GpR study, a follow-up study was initiated to expand the registry (GpR 2).
Diabetes, Multidisciplinary Research, Digestive Diseases
Observational
7
2006-12
2011-03
Type 2 Diabetes Mellitus, Type 1 Diabetes Mellitus, Gastroparesis
Gastroparesis, erythrocyte sedimentation rate (ESR), Beck Depression Inventory (BDI), C Reactive Protein (CRP), Gastrointestinal Disease, Patient Assessment of Upper Gastrointestinal Disorders Symptoms Severity Index (PAGI-SYM), State-Trait Anxiety Inventory (STAI)
Division of Digestive Diseases and Nutrition
Document Name | Description | Document Type | File Format | Compliance | Download |
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Document Name | Description | Document Type | File Format |
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Dataset Name | Description | # of Records | # of Variables | File Format(s) |
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PAGI-QOL Form Dataset | This dataset is in the format of one record per subject visit, and contains information on mood and how gastroparesis affects daily life and feelings | 2964 | sas7bdat (256 KB); csv (400.8 KB) | |
Gastric Emptying Scintigraphy Documentation Form Dataset | This dataset is in the format of one record per subject visit, and reports the results of the gastric emptying scintigraphy test | 3045 | sas7bdat (576 KB); csv (343.6 KB) | |
Interim Event Report Form Dataset | This dataset is in the format of one record per subject’s interim event (defined as any event, such as an Emergency Room visit, that does not occur at a normal study visit and is not recorded on a different form. It includes description and severity of the event. | 99 | sas7bdat (128 KB); csv (18.91 KB) | |
Physical Examination Form Dataset | This dataset is in the format of one record per subject visit, and contains information such as height, weight, blood pressure, and any abnormal findings on the body | 2948 | sas7bdat (960 KB); csv (447.11 KB) | |
Registration Form Dataset | This dataset is in the format of one record per subject, and contains basic demographic information, such as age, gender, race, education level, and income | 572 | sas7bdat (128 KB); csv (52.86 KB) | |
Beck Depression Inventory Dataset | This dataset is in the format of one record per subject visit, and contains limited variables, such as overall score, from the Beck Depression Inventory | 1231 | sas7bdat (128 KB); csv (41.54 KB) | |
Death Report Form Dataset | This dataset is in the format of one record per subject, for each subject that died during the study. It includes cause and location of death, as well as any co-morbidities | 19 | sas7bdat (128 KB); csv (1.93 KB) | |
State-Trait Anxiety Inventory Form Dataset | This dataset is in the format of one record per subject visit, and contains the overall scores relating to the psychosocial aspects of gastroparesis | 1225 | sas7bdat (128 KB); csv (32.94 KB) | |
PAGI-SYM Form Dataset | This dataset is in the format of one record per subject visit, and reports on the severity of different gastroparesis symptoms | 2987 | sas7bdat (320 KB); csv (349.7 KB) | |
Follow-up Medical History Form Dataset | This dataset is in the format of one record per subject visit, and contains health history, such as gastroparesis history, medical history, alcohol and smoking use, and medication use at follow-up visits | 2522 | sas7bdat (3.5 MB); csv (3.18 MB) | |
Rome III Diagnostic Questionnaire Form Dataset | This dataset is in the format of one record per subject visit, and contains self-reported symptoms in the stomach and esophagus | 1231 | sas7bdat (192 KB); csv (250.94 KB) | |
Laboratory Results Dataset | This dataset is in the format of one record per subject visit, and contains the results of laboratory tests, such as the hepatic panel, chemistries and HbA1c, hematology, and antibodies | 3017 | sas7bdat (896 KB); csv (646.18 KB) | |
Brief Pain Inventory Form Dataset | This dataset is in the format of one record per subject visit, and contains information on types and severity of pain, and how it impacts daily life | 2983 | sas7bdat (576 KB); csv (290.33 KB) | |
QF1 Dataset | This dataset is in the format of one record per subject visit, and contains information on overall health, ability to perform certain activities, and general feelings toward health | 1229 | sas7bdat (192 KB); csv (194.19 KB) | |
Base Medical History Form Dataset | This dataset is in the format of one record per subject, and contains health history, such as gastroparesis history, medical history, alcohol and smoking use, and medication use at baseline | 572 | sas7bdat (1008 KB); csv (851.68 KB) | |
IDIOMS Form Dataset | This dataset is in the format of one record per subject visit, and records the severity of the illness, other significant illnesses, and intensity of services | 3017 | sas7bdat (192 KB); csv (113.15 KB) | |
Upper Endoscopy Documentation Form Dataset | This dataset is in the format of one record per subject visit, and contains the endoscopic findings | 3044 | sas7bdat (1.5 MB); csv (779.06 KB) |
Specimen | Count |
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Plasma | 7798 |
Serum | 6832 |