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No participants enrolled. Study terminated at PI's discretion
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The purpose of this registry is to evaluate if sleeve gastrectomy surgery will help with symptoms of delayed gastric emptying for patients suffering from diabetic gastroparesis.
This is a prospective registry enrolling patients with an established diagnosis of diabetic gastroparesis and interested in receiving a sleeve gastrectomy for weight loss. An often intentional outcome of sleeve gastrectomy is an increase in gastric emptying. The relationship between how beneficial this outcome could be for diabetic gastroparesis patients suffering from delayed gastric emptying is not very well established. The purpose of this study is to find out if sleeve gastrectomy surgery will also help with symptoms of delayed gastric emptying. This study involves completing the Gastroparesis Cardinal Symptom Index questionnaire before your weight loss surgery and after surgery at the following time points; 30 days, 3 months, 6 months, and 12 months.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gastroparesis Cardinal Symptom Index Questionnaire | Other | Patients with an established diagnosis of Diabetic Gastroparesis that are interested in a sleeve gastrectomy for weight loss will be asked to participate in the registry. Once the consent process is complete the patient will be asked to complete the Gastroparesis Cardinal Symptom Index Questionnaire prior to weight loss surgery and 30 days, 3 months, 6 months and 12 months after surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| Examine gastroparesis symptoms | Administer the Gastroparesis Cardinal Symptom Index (GCSI). The GCSI consists of three subscales: (1) Nausea/vomiting, (2) Fullness/early satiety, and (3) Bloating/distention. The average score is calculated from these three subscales with higher scores indicating greater symptom severity. The symptoms are rated on a scale from 0-5 with zero reflecting no symptoms and 5 indicating very severe symptoms. | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
- Any previous weight loss surgery or prior gastrectomies
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The study group will be patients with diabetic gastroparesis who qualify for bariatric weight loss surgery (BMI >35, insurance/medicare bariatric coverage). These patients are referred by gastroenterologists and/or endocrinologists with established diagnosis of diabetic gastroparesis confirmed via delayed gastric emptying on scintigraphy. All available treatment options will be discussed with every qualifying patient. Patients opting for sleeve gastrectomy will be invited to participate in the registry.
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| Name | Affiliation | Role |
|---|---|---|
| Daniel Davis, DO | Baylor Scott & White, Baylor University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baylor Weight Loss Surgery Center | Dallas | Texas | 75231 | United States |
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| ID | Term |
|---|---|
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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