Gastric and Autonomic Functions in Patients With Intragastric Balloon

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

Study Overview

• Status: Withdrawn
• Conditions: Obesity; Obesity, Morbid
• Intervention / Treatment: Device: Intragastric balloon placement

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 Type: Observational

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients scheduled to undergo intragastric balloon implantation

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with intragastric balloon; Patients who will receive an intragastric balloon placement for weight loss	Device: Intragastric balloon placement; Patients will have endoscopic placement of intragastric balloon that will be removed endoscopically after 6 months

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Johns Hopkins University

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): March 1, 2021
• Primary Completion (ANTICIPATED): March 1, 2022
• Study Completion (ANTICIPATED): March 1, 2022

Study Registration Dates

• First Submitted: May 8, 2018
• First Submitted That Met QC Criteria: May 8, 2018
• First Posted (ACTUAL): May 21, 2018

Study Record Updates

• Last Update Posted (ACTUAL): March 30, 2021
• Last Update Submitted That Met QC Criteria: March 25, 2021
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Obesity, Morbid
• Other Study ID Numbers: IRB00154036

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes