Potential Benefits of Sleeve Gastrectomy Surgery on Diabetic Gastroparesis Symptoms

Withdrawn

• Conditions: Gastric Emptying; Sleeve Gastrectomy; Weight Loss; Bariatric Surgery Candidate; Diabetic Gastroparesis

• Registration Number: NCT03376399
• Lead Sponsor: Baylor Research Institute

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.

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 Timeline

• Study Start: 2017-10-25
• Study First Submitted: 2017-12-13
• Study First Submitted QC: 2017-12-13
• Study First Posted: 2017-12-18
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-30
• Last Update Posted: 2020-07-02
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Baylor Weight Loss Surgery Center; 🇺🇸 Dallas, Texas, United States