Gastric and Autonomic Functions in Patients With Intragastric Balloon

NCT ID: NCT03530410

Last Updated: 2021-03-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2021-03-31

Study Completion Date

2022-03-31

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.

Conditions

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Obesity Obesity, Morbid

Study Design

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Observational Model Type

CASE_CROSSOVER

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with intragastric balloon

Patients who will receive an intragastric balloon placement for weight loss

Intragastric balloon placement

Intervention Type DEVICE

Patients will have endoscopic placement of intragastric balloon that will be removed endoscopically after 6 months

Interventions

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Intragastric balloon placement

Patients will have endoscopic placement of intragastric balloon that will be removed endoscopically after 6 months

Intervention Type DEVICE

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Johns Hopkins University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Vivek Kumbhari, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Other Identifiers

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IRB00154036

Identifier Type: -

Identifier Source: org_study_id

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