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Potential Benefits of Sleeve Gastrectomy Surgery on Diabetic Gastroparesis Symptoms

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03376399
Recruitment Status : Withdrawn (No participants enrolled. Study terminated at PI's discretion)
First Posted : December 18, 2017
Last Update Posted : July 2, 2020
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
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.

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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 : October 25, 2017
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine



Intervention Details:
  • Other: 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.


Primary Outcome Measures :
  1. Examine gastroparesis symptoms [ Time Frame: 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
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.
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03376399


Locations
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United States, Texas
Baylor Weight Loss Surgery Center
Dallas, Texas, United States, 75231
Sponsors and Collaborators
Baylor Research Institute
Investigators
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Principal Investigator: Daniel Davis, DO Baylor Scott & White, Baylor University Medical Center
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Responsible Party: Baylor Research Institute
ClinicalTrials.gov Identifier: NCT03376399    
Other Study ID Numbers: IRB 017-370
First Posted: December 18, 2017    Key Record Dates
Last Update Posted: July 2, 2020
Last Verified: June 2020

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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:
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Gastroparesis
Weight Loss
Body Weight Changes
Body Weight
Signs and Symptoms
Stomach Diseases
Gastrointestinal Diseases
Digestive System Diseases
Paralysis
Neurologic Manifestations