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Potential Benefits of Sleeve Gastrectomy Surgery on Diabetic Gastroparesis Symptoms

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

Status
Withdrawn
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03376399
Enrollment
0
Registered
2017-12-18
Start date
2017-10-25
Completion date
2020-12-31
Last updated
2020-07-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bariatric Surgery Candidate, Diabetic Gastroparesis, Gastric Emptying, Sleeve Gastrectomy, Weight Loss

Keywords

Sleeve Gastrectomy, Gastric Emptying, Diabetic Gastroparesis, Bariatric Surgery Candidate

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.

Interventions

OTHERGastroparesis 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.

Sponsors

Baylor Research Institute
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

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

Design outcomes

Primary

MeasureTime frameDescription
Examine gastroparesis symptoms1 yearAdminister 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026