Gastric and Autonomic Functions in Patients With Intragastric Balloon

Johns Hopkins University

Status: Withdrawn

Conditions: Obesity; Obesity, Morbid

Treatments: Device: Intragastric balloon placement

Study type: Observational

Funder types: Other

Identifiers

NCT03530410

IRB00154036

Details and patient eligibility

About

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

Full 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.

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

0 participants in 1 patient group

Patients with intragastric balloon

Description:

Patients who will receive an intragastric balloon placement for weight loss

Treatment:

Device: Intragastric balloon placement