Gastric and Autonomic Functions in Patients With Intragastric Balloon

Obesity Clinical Trial

Official title:

Gastric and Autonomic Functions in Patients With Intragastric Balloon

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03530410
• Other study ID #: IRB00154036
• Status: Withdrawn
• Start date: March 2021
• Est. completion date: March 2022

Study information

• Verified date: March 2020
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 2022
• Est. primary completion date: March 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Obesity
• Obesity, Morbid

Intervention

Device:
• Intragastric balloon placement
Patients will have endoscopic placement of intragastric balloon that will be removed endoscopically after 6 months

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Gastroparesis cardinal symptom index (GCSI) questionnaire	Gastroparesis symptoms questionnaire. Score ranges from 0 (none) to 45 (very severe)	1 year
Secondary	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
Secondary	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
Secondary	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