Study Stopped
No participants enrolled. Study terminated at PI's discretion
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?
1 other identifier
observational
N/A
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Oct 2017
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 25, 2017
CompletedFirst Submitted
Initial submission to the registry
December 13, 2017
CompletedFirst Posted
Study publicly available on registry
December 18, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2020
CompletedJuly 2, 2020
June 1, 2020
3.2 years
December 13, 2017
June 30, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Interventions
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.
Eligibility Criteria
The study group will be patients with diabetic gastroparesis who qualify for bariatric weight loss surgery (BMI \>35, insurance/medicare bariatric coverage). These patients are referred by gastroenterologists and/or endocrinologists with established diagnosis of diabetic gastroparesis confirmed via delayed gastric emptying on scintigraphy. All available treatment options will be discussed with every qualifying patient. Patients opting for sleeve gastrectomy will be invited to participate in the registry.
You may qualify if:
- Age 18 years and above
- BMI \> 35
- Diagnosis of diabetic gastroparesis as confirmed via scintigraphy
- Subject opting to undergo sleeve gastrectomy
You may not qualify if:
- \- Any previous weight loss surgery or prior gastrectomies
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Baylor Weight Loss Surgery Center
Dallas, Texas, 75231, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Daniel Davis, DO
Baylor Scott & White, Baylor University Medical Center
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 13, 2017
First Posted
December 18, 2017
Study Start
October 25, 2017
Primary Completion
December 31, 2020
Study Completion
December 31, 2020
Last Updated
July 2, 2020
Record last verified: 2020-06