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Trial record 32 of 43 for:    Recruiting, Not yet recruiting, Available Studies | "Gastroparesis"

Potential Benefits of Sleeve Gastrectomy Surgery on Diabetic Gastroparesis Symptoms

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ClinicalTrials.gov Identifier: NCT03376399
Recruitment Status : Recruiting
First Posted : December 18, 2017
Last Update Posted : December 26, 2017
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.

Study Type : Observational
Estimated Enrollment : 30 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, 2019
Estimated Study Completion Date : December 31, 2019

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.



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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


Contacts
Contact: Estrellita Ontiveros, MA 214-820-5283 estrellita.ontiveros@bswhealth.org

Locations
United States, Texas
Baylor Weight Loss Surgery Center Recruiting
Dallas, Texas, United States, 75231
Contact: Estrellita Ontiveros, MA    214-820-5283    estrellita.ontiveros@bswhealth.org   
Principal Investigator: Daniel Davis, DO         
Sponsors and Collaborators
Baylor Research Institute
Investigators
Principal Investigator: Daniel Davis, DO Baylor Scott & White, Baylor University Medical Center

Responsible Party: Baylor Research Institute
ClinicalTrials.gov Identifier: NCT03376399     History of Changes
Other Study ID Numbers: IRB 017-370
First Posted: December 18, 2017    Key Record Dates
Last Update Posted: December 26, 2017
Last Verified: December 2017

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