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NCT03376399 Clinical Trial

Potential Benefits of Sleeve Gastrectomy Surgery on Diabetic Gastroparesis Symptoms

Weight Loss Clinical Trial

Official title:
Do Sleeve Gastrectomies Result in Improved Gastric Emptying and Thus Improved Symptoms in Patients With Diabetic Gastroparesis?

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT03376399
Other study ID # IRB 017-370
Secondary ID
Status Withdrawn
Phase
First received
Last updated
Start date October 25, 2017
Est. completion date December 31, 2020

Study information
Verified date June 2020
Source Baylor Research Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date December 31, 2020
Est. primary completion date December 31, 2020
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Age 18 years and above

- BMI > 35

- Diagnosis of diabetic gastroparesis as confirmed via scintigraphy

- Subject opting to undergo sleeve gastrectomy

Exclusion Criteria:

- Any previous weight loss surgery or prior gastrectomies

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Gastroparesis Cardinal Symptom Index Questionnaire
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.

Locations
Country Name City State
United States Baylor Weight Loss Surgery Center Dallas Texas

Sponsors (1)
Lead Sponsor Collaborator
Baylor Research Institute

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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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