Gastrointestinal Physiological Conditions in Obesity and After Bariatric Surgery (GASTON)

Over the years, obesity has become a major public health concern. The increasing rates of obesity are associated with an enhanced demand for weight-loss with bariatric surgery as a treatment option. Bariatric surgery procedures alter the anatomical structure of the gastrointestinal tract, which contributes to the postoperative weight loss. However, it is not sure how obesity and the anatomical alterations of bariatric surgery affect the gastrointestinal physiology including gastrointestinal pH, gastric emptying, intestinal transit time and concentration of enzymes.

Study Overview

• Status: Completed
• Conditions: Obesity; Bariatric Surgery Candidate
• Intervention / Treatment: Device: SmartPill in fasted state; Device: SmartPill in fed state; Other: Aspiration; Other: Gastric emptying scintigraphy

Detailed Description

During the visit in the obesity clinic, eligible patients will be approached for participation by the sub-investigator. Interested patients will receive information regarding the study and receive the information sheet containing the informed consent form. After signing the informed consent form, volunteers will be invited to come to the clinical research center:

• Healthy volunteers: Gastrointestinal physiology will be analyzed during two visits using a telemetric capsule. During the first visit, the physiological conditions of interest will be analysed in fasted state using the telemetric capsule. During the second visit, the physiological conditions of interest will be analysed in fed state using the telemetric capsule.
• Obese volunteers: Gastrointestinal physiology will be analyzed during two visits using a telemetric capsule. During the first visit, the physiological conditions of interest will be analysed in fasted state using the telemetric capsule. During the second visit, the physiological conditions of interest will be analysed in fed state using the telemetric capsule.
• Obese volunteers: Gastrointestinal physiology will be analyzed during three visits using a telemetric capsule, scintigraphy and via the collection of gastrointestinal samples. During the first visit, the physiological conditions of interest will be analysed in fasted state using the telemetric capsule. During the second visit, gastrointestinal samples will be collected at the level of the stomach, the duodenum and jejunum via aspiration through multiple lumen catheters in fasted and fed state. During the third visit, gastric emptying will be observed via scintigraphy in fed state.
• Volunteers after Sleeve Gastrectomy: Gastrointestinal physiology will be analyzed during three visits using a telemetric capsule, scintigraphy and via the collection of gastrointestinal samples. During the first visit, the physiological conditions of interest will be analysed in fasted state using the telemetric capsule. During the second visit, gastrointestinal samples will be collected at the level of the sleeve, the duodenum and jejunum via aspiration through multiple lumen catheters in fasted and fed state. During the third visit, gastric emptying will be observed via scintigraphy in fed state.
• Volunteers after Roux-en-Y gastric Bypass: Gastrointestinal physiology will be analyzed during three visits using a telemetric capsule, scintigraphy and via the collection of gastrointestinal samples. During the first visit, the physiological conditions of interest will be analysed in fasted state using the telemetric capsule. During the second visit, gastrointestinal samples will be collected at the level of the pouch, the Roux limb and the common limb via aspiration through multiple lumen catheters in fasted and fed state. During the third visit, gastric emptying will be observed via scintigraphy in fed state.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Leuven, Belgium, 3000
    • UZ Leuven

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

- 18 years or older

Exclusion Criteria:

• History of gastric ulcers
• Disorders of swallowing
• Suspected strictures, fistulas or physiological GI obstruction.
• GI surgery within past three months
• Severe dysphagia to food or pills
• Crohns disease or diverticulitis
• Use of implanted or portable electro-mechanical medical devices
• Known intolerance to the SmartPill device
• Known food allergies to any component of the meal
• History of multiple bariatric surgeries
• Pregnant or lactating women

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Healthy volunteers; 11 Healthy volunteers	Device: SmartPill in fasted state; SmartPill administration in fasted state; Device: SmartPill in fed state; SmartPill administration in fed state
Other: Obese volunteers; 11 Obese Volunteers	Device: SmartPill in fasted state; SmartPill administration in fasted state; Device: SmartPill in fed state; SmartPill administration in fed state
Other: Roux-en-Y Gastric Bypass patients; 6 volunteers with a Roux-en-Y Gastric Bypass	Device: SmartPill in fasted state; SmartPill administration in fasted state; Other: Aspiration; Aspiration of gastrointestinal samples in fasted and fed state; Other: Gastric emptying scintigraphy; Gastric emptying scintigraphy in fed state
Other: Sleeve Gastrectomy patients; 6 volunteers with a Sleeve Gastrectomy	Device: SmartPill in fasted state; SmartPill administration in fasted state; Other: Aspiration; Aspiration of gastrointestinal samples in fasted and fed state; Other: Gastric emptying scintigraphy; Gastric emptying scintigraphy in fed state
Other: Volunteers with obesity; 6 obese volunteers	Device: SmartPill in fasted state; SmartPill administration in fasted state; Other: Aspiration; Aspiration of gastrointestinal samples in fasted and fed state; Other: Gastric emptying scintigraphy; Gastric emptying scintigraphy in fed state

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gastrointestinal Temperature	Gastrointestinal Temperature (°C)	0-7 days
Gastrointestinal pH	Gastrointestinal pH (pH values)	0-7 days
Gastrointestinal Pressure	Gastrointestinal Pressure (mmHg)	0-7 days
Concentration of bile acids	Concentration of bile acids	1 day
Gastric emptying time	Gastric emptying time	2 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gastrointestinal motility	Contractions per minute	0-7 days
Gastrointestinal transit times	Gastric Emptying Time (hours), Small Bowel Transit Time (hours), Colonic Transit Time (hours) and Whole Gut Transit Time (hours)	0-7 days

Collaborators and Investigators

• Sponsor: Universitaire Ziekenhuizen KU Leuven
• Investigators: Principal Investigator: Bart Van der Schueren, PhD, UZ Leuven, Department of Endocrinology

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2018
• Primary Completion (Actual): March 30, 2021
• Study Completion (Actual): March 30, 2021

Study Registration Dates

• First Submitted: August 10, 2018
• First Submitted That Met QC Criteria: December 18, 2018
• First Posted (Actual): December 20, 2018

Study Record Updates

• Last Update Posted (Actual): October 19, 2022
• Last Update Submitted That Met QC Criteria: October 18, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity
• Other Study ID Numbers: S60930

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes