Gastric and Autonomic Functions in Patients With Intragastric Balloon

Withdrawn

• Conditions: Obesity; Obesity, Morbid
• Interventions: Device: Intragastric balloon placement

• Registration Number: NCT03530410
• Lead Sponsor: Johns Hopkins University

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2018-05-08
• Study First Submitted QC: 2018-05-08
• Study First Posted: 2018-05-21
• Status Verified: 2020-03
• Study Start: 2021-03
• Last Update Submitted: 2021-03-25
• Last Update Posted: 2021-03-30
• Primary Completion: 2022-03
• Study Completion: 2022-03

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with intragastric balloon	Intragastric balloon placement	Patients who will receive an intragastric balloon placement for weight loss

Primary Outcome Measures

Name	Time	Method
Gastric slow waves	1 year	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
Gastric accommodation	1 year	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
Autonomic function	1 year	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

Secondary Outcome Measures

Name	Time	Method
Dyspepsia symptom severity index (DSSI) questionnaire	1 year	A tool for assessing the severity of symptoms commonly associated with dyspepsia. Score ranges from 0 to 4 based on severity.
Gastroparesis cardinal symptom index (GCSI) questionnaire	1 year	Gastroparesis symptoms questionnaire. Score ranges from 0 (none) to 45 (very severe)
Gastroesophageal reflux disease-health related quality of life (GERD-HRQL) questionnaire	1 year	A tool for measuring symptom severity in gastroesophageal reflux disease (GERD). Score ranges from 0 (no symptoms) to 75 (worst symptoms)
SF-36 Questionnaire	1 year	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).