Potential Benefits of Sleeve Gastrectomy Surgery on Diabetic Gastroparesis Symptoms

NCT ID: NCT03376399

Last Updated: 2020-07-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2017-10-25

Study Completion Date

2020-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Weight Loss Diabetic Gastroparesis Bariatric Surgery Candidate Sleeve Gastrectomy Gastric Emptying

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Baylor Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Daniel Davis, DO

Role: PRINCIPAL_INVESTIGATOR

Baylor Scott & White, Baylor University Medical Center

Locations

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Baylor Weight Loss Surgery Center

Dallas, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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IRB 017-370

Identifier Type: -

Identifier Source: org_study_id

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