Gastric and Autonomic Functions in Patients With Intragastric Balloon

Study Overview
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Brief Summary
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The study aims to measure the effect of intragastric balloon on gastric function, particularly gastric accommodation and pace making, and the possible underlying changes in autonomic function

Detailed Description
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The intragastric balloon is a space-occupying device that is hypothesized to function by inducing early satiety. Additionally, insertion of an intragastric balloon causes delayed gastric emptying; longer gastric emptying times after balloon insertion are correlated with more weight loss. The exact mechanism of function, however, is not clear and likely multifactorial. The investigators hypothesize that the intragastric balloon causes weight loss by affecting gastric and autonomic function, including pace-making and accommodation, and that the difference in responsiveness among patients may be mediated by differences in gastric function.

Official Title
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Gastric and Autonomic Functions in Patients With Intragastric Balloon

Conditions
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Obesity, Obesity, Morbid

Intervention / Treatment
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* Device: Intragastric balloon placement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients scheduled to undergo intragastric balloon implantation Ability to comply to study schedule. Exclusion Criteria: Unable to give informed consent Currently taking prokinetic, anticholinergic or dopaminergic agents which could potentially modify gastric motility Have a history of bariatric or gastrointestinal surgery Pregnant or preparing to conceive a child.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with intragastric balloon<br>Patients who will receive an intragastric balloon placement for weight loss | Device: Intragastric balloon placement<br>* Patients will have endoscopic placement of intragastric balloon that will be removed endoscopically after 6 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gastric slow waves | A noninvasive method similar to electrocardiography, called electrogastrography, will be used in this study to assess the effects of intragastric balloon on gastric slow waves | 1 year | 
| Gastric accommodation | A noninvasive nutrient drink test will be performed and accommodation will be assessed using a symptom (fullness, nausea, belching of air, cramps in the abdomen, bloating, and pain) scale 0 to 3 points with higher values indicating more and/or greater symptoms | 1 year | 
| Autonomic function | The ECG will be recorded simultaneously with the Electrogastrograph (EGG) and will be used to noninvasively assess the vagal and sympathetic activities as well as the sympathovagal ratio | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gastroparesis cardinal symptom index (GCSI) questionnaire | Gastroparesis symptoms questionnaire. Score ranges from 0 (none) to 45 (very severe) | 1 year | 
| Gastroesophageal reflux disease-health related quality of life (GERD-HRQL) questionnaire | A tool for measuring symptom severity in gastroesophageal reflux disease (GERD). Score ranges from 0 (no symptoms) to 75 (worst symptoms) | 1 year | 
| Dyspepsia symptom severity index (DSSI) questionnaire | A tool for assessing the severity of symptoms commonly associated with dyspepsia. Score ranges from 0 to 4 based on severity. | 1 year | 
| SF-36 Questionnaire | 36 item questionnaire which measures Quality of Life (QoL) across eight domains. Scores range from 0% (lowest level of functioning) to 100% (highest level of functioning). | 1 year |