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

Primary Purpose

Obesity, Bariatric Surgery Candidate

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
SmartPill in fasted state
SmartPill in fed state
Aspiration
Gastric emptying scintigraphy
Sponsored by
Universitaire Ziekenhuizen KU Leuven
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Obesity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • UZ Leuven

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Other

Other

Other

Other

Other

Arm Label

Healthy volunteers

Obese volunteers

Roux-en-Y Gastric Bypass patients

Sleeve Gastrectomy patients

Volunteers with obesity

Arm Description

11 Healthy volunteers

11 Obese Volunteers

6 volunteers with a Roux-en-Y Gastric Bypass

6 volunteers with a Sleeve Gastrectomy

6 obese volunteers

Outcomes

Primary Outcome Measures

Gastrointestinal Temperature
Gastrointestinal Temperature (°C)
Gastrointestinal pH
Gastrointestinal pH (pH values)
Gastrointestinal Pressure
Gastrointestinal Pressure (mmHg)
Concentration of bile acids
Concentration of bile acids
Gastric emptying time
Gastric emptying time

Secondary Outcome Measures

Gastrointestinal motility
Contractions per minute
Gastrointestinal transit times
Gastric Emptying Time (hours), Small Bowel Transit Time (hours), Colonic Transit Time (hours) and Whole Gut Transit Time (hours)

Full Information

First Posted
August 10, 2018
Last Updated
October 18, 2022
Sponsor
Universitaire Ziekenhuizen KU Leuven
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1. Study Identification

Unique Protocol Identification Number
NCT03783052
Brief Title
Gastrointestinal Physiological Conditions in Obesity and After Bariatric Surgery
Acronym
GASTON
Official Title
Gastrointestinal Physiological Conditions in Obesity and After Bariatric Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
February 1, 2018 (Actual)
Primary Completion Date
March 30, 2021 (Actual)
Study Completion Date
March 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universitaire Ziekenhuizen KU Leuven

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Bariatric Surgery Candidate

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Healthy volunteers
Arm Type
Other
Arm Description
11 Healthy volunteers
Arm Title
Obese volunteers
Arm Type
Other
Arm Description
11 Obese Volunteers
Arm Title
Roux-en-Y Gastric Bypass patients
Arm Type
Other
Arm Description
6 volunteers with a Roux-en-Y Gastric Bypass
Arm Title
Sleeve Gastrectomy patients
Arm Type
Other
Arm Description
6 volunteers with a Sleeve Gastrectomy
Arm Title
Volunteers with obesity
Arm Type
Other
Arm Description
6 obese volunteers
Intervention Type
Device
Intervention Name(s)
SmartPill in fasted state
Intervention Description
SmartPill administration in fasted state
Intervention Type
Device
Intervention Name(s)
SmartPill in fed state
Intervention Description
SmartPill administration in fed state
Intervention Type
Other
Intervention Name(s)
Aspiration
Intervention Description
Aspiration of gastrointestinal samples in fasted and fed state
Intervention Type
Other
Intervention Name(s)
Gastric emptying scintigraphy
Intervention Description
Gastric emptying scintigraphy in fed state
Primary Outcome Measure Information:
Title
Gastrointestinal Temperature
Description
Gastrointestinal Temperature (°C)
Time Frame
0-7 days
Title
Gastrointestinal pH
Description
Gastrointestinal pH (pH values)
Time Frame
0-7 days
Title
Gastrointestinal Pressure
Description
Gastrointestinal Pressure (mmHg)
Time Frame
0-7 days
Title
Concentration of bile acids
Description
Concentration of bile acids
Time Frame
1 day
Title
Gastric emptying time
Description
Gastric emptying time
Time Frame
2 hours
Secondary Outcome Measure Information:
Title
Gastrointestinal motility
Description
Contractions per minute
Time Frame
0-7 days
Title
Gastrointestinal transit times
Description
Gastric Emptying Time (hours), Small Bowel Transit Time (hours), Colonic Transit Time (hours) and Whole Gut Transit Time (hours)
Time Frame
0-7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bart Van der Schueren, PhD
Organizational Affiliation
UZ Leuven, Department of Endocrinology
Official's Role
Principal Investigator
Facility Information:
Facility Name
UZ Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Gastrointestinal Physiological Conditions in Obesity and After Bariatric Surgery

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