ClinicalTrials.gg
WithdrawnNCT03376399Updated Jul 2, 2020

Potential Benefits of Sleeve Gastrectomy Surgery on Diabetic Gastroparesis Symptoms

An observational study in Weight Loss, Diabetic Gastroparesis and Bariatric Surgery Candidate, sponsored by Baylor Research Institute. Withdrawn at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-07-02.

Sponsored by Baylor Research Institute · Observational

Why this study was withdrawn
No participants enrolled. Study terminated at PI's discretion
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
0
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 995 studies in Weight Loss with a site in United States — 114 open to participants now, 169 under way, 6 of them phase 3. Weight Loss · United States.

Enrollment
76th of 76
0 · median 99
Started
2017
with 61 others
Observational
77 of 995
18 open now
Registered
570th of 995
by date

Among the 995 studies in Weight Loss with a site in United States, this one is the 76th largest by enrollment of the 76 observational ones that give a count, is one of 62 that started in 2017, is one of 77 observational ones, and was the 570th registered.

Weight Loss

1,815 studies on the registry are indexed under Weight Loss; 294 are open to participants now.

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Open to participants now

114 of the 995 studies in Weight Loss with a site in United States are open now. Recruiting first, the newest first:

109 more — sign in →

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A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 196 Weight Loss studies recruiting now, 71 (36%) set no upper age limit and 108 (55%) stop at 75 or younger; 21 take children under 18; 58 take healthy volunteers.

This study: 18 Years and older · all sexes.

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02

Study 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.

Read the 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.

03

Conditions studied

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

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Keywords

  • Sleeve Gastrectomy
  • Gastric Emptying
  • Diabetic Gastroparesis
  • Bariatric Surgery Candidate
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age 18 years and above
  • > 35
  • Diagnosis of diabetic gastroparesis as confirmed via scintigraphy
  • Subject opting to undergo sleeve gastrectomy

Exclusion criteria

Exclusion Criteria:

  • Any previous weight loss surgery or prior gastrectomies
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
0 participants (actual)
Patient registry
No

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.

06

What researchers measure

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.

    Time frame: 1 year

07

Study locations

1 site
  • Baylor Weight Loss Surgery Center
    Dallas, Texas 75231, United States
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Oct 2017 (actual). Primary completion is estimated for Dec 2020, 38 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 13, 2017
First posted
Dec 18, 2017
StartActual
Oct 25, 2017
Primary completionEst.
Dec 31, 2020
CompletionEst.
Dec 31, 2020
Last update
Jul 2, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 2, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03376399
Responsible party
Sponsor
First posted
Dec 18, 2017
Start date
Oct 25, 2017
Primary completion
Dec 31, 2020 (estimated)
Completion
Dec 31, 2020 (estimated)
Last update
Jul 2, 2020

Study contacts

Daniel Davis, DO
principal investigator · Baylor Scott & White, Baylor University Medical Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.

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