An official website of the United States government

Citation
Tonascia, James (2019). Gastroparesis Registry (GpR) (Version 1) [Dataset] NIDDK Central Repository. https://doi.org/10.58020/na8s-5602
Data Availability Statement
Data from the Gastroparesis Registry (GpR) [(Version 1) https://doi.org/10.58020/na8s-5602] reported here are available for request at the NIDDK Central Repository (NIDDK-CR) website, Resources for Research (R4R), https://repository.niddk.nih.gov/.
Acknowledgement Statement
The GpR study was conducted by the study investigators and supported by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The resources from the GpR (https://doi.org/10.58020/na8s-5602) study reported here were supplied by NIDDK Central Repository (NIDDK-CR) and are available for request at https://repository.niddk.nih.gov. This manuscript was not prepared under the auspices of the GpR study and does not necessarily reflect the opinions or views of the GpR study, NIDDK-CR, or NIDDK.
Data Package Version
Version 1 (Updated on: Feb 28, 2019)
Resource Availability
  • Data Available for Request
  • Specimens Available for Request
Publications
Explore publications resulting from the use of study resources
View publications (1)

General Description

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).

Objectives

The primary objectives of the study included investigating the etiology of gastroparesis and elucidating the clinical features and outcomes of the condition.

Eligibility Criteria

Individuals of at least 18 years of age who met the following criteria were eligible for enrollment:

  • Symptoms of gastroparesis of at least 12 weeks duration (do not have to be contiguous) with varying degrees of nausea, vomiting, abdominal pain, early satiety, and post-prandial fullness
  • Completion of a 4-hour scintigraphic gastric emptying study (for classification of definite gastroparesis or gastroparesis-like with normal gastric emptying)
  • No abnormality causing obstruction on upper endoscopy

Exclusion criteria are documented in the study protocol.

Outcome

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).

Research Area

Diabetes, Multidisciplinary Research, Digestive Diseases

Study Type

Observational

Study Sites

7

Study Start Date

2006-12

Study End Date

2011-03

Condition

Type 2 Diabetes Mellitus, Type 1 Diabetes Mellitus, Gastroparesis

Keywords

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)

NIDDK Division

Division of Digestive Diseases and Nutrition

572
Participants

Target Population
Adults

Public Documents Table
Document Name
Description
Document Type
File Format
Compliance
Download

Non-Public Documents (3)
Non-Public Documents Table
Document Name
Description
Document Type
File Format
Datasets (17)
Datasets Table
Dataset Name
Description
# of Records
# of Variables
File Format(s)
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 feelings2964sas7bdat (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 test3045sas7bdat (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.99sas7bdat (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 body2948sas7bdat (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 income572sas7bdat (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 Inventory1231sas7bdat (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-morbidities19sas7bdat (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 gastroparesis1225sas7bdat (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 symptoms2987sas7bdat (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 visits2522sas7bdat (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 esophagus1231sas7bdat (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 antibodies3017sas7bdat (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 life2983sas7bdat (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 health1229sas7bdat (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 baseline572sas7bdat (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 services3017sas7bdat (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 findings3044sas7bdat (1.5 MB); csv (779.06 KB)
Specimens (14,630)
Specimens Table
Specimen
Count
Plasma7798
Serum6832