Potential Benefits of Sleeve Gastrectomy Surgery on Diabetic Gastroparesis Symptoms

• Sponsor: Baylor Research Institute (Other)
• Overall Status: Withdrawn
• CT.gov ID: NCT03376399
• Collaborator: (none)
• Enrollment: 0
• Location: 1
• Anticipated Duration (Months): 38.2
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Weight Loss; Diabetic Gastroparesis; Bariatric Surgery Candidate; Sleeve Gastrectomy; Gastric Emptying	Other: Gastroparesis Cardinal Symptom Index Questionnaire

Detailed 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.

Study Design

• Study Type: Observational
• Actual Enrollment: 0 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Do Sleeve Gastrectomies Result in Improved Gastric Emptying and Thus Improved Symptoms in Patients With Diabetic Gastroparesis?
• Actual Study Start Date: Oct 25, 2017
• Anticipated Primary Completion Date: Dec 31, 2020
• Anticipated Study Completion Date: Dec 31, 2020

Outcome Measures

Primary Outcome Measures

1. Examine gastroparesis symptoms [1 year]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Baylor Weight Loss Surgery Center	Dallas	Texas	United States	75231

Sponsors and Collaborators

• Baylor Research Institute

Investigators

• Principal Investigator: Daniel Davis, DO, Baylor Scott & White, Baylor University Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Baylor Research Institute
• ClinicalTrials.gov Identifier: NCT03376399
• Other Study ID Numbers: IRB 017-370
• First Posted: Dec 18, 2017
• Last Update Posted: Jul 2, 2020
• Last Verified: Jun 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Baylor Research Institute: Sleeve Gastrectomy; Gastric Emptying; Diabetic Gastroparesis; Bariatric Surgery Candidate
• Additional relevant MeSH terms: Gastroparesis; Weight Loss

Study Results

No Results Posted as of Jul 2, 2020