Gastrointestinal Physiological Conditions in Obesity and After Bariatric Surgery

Obesity Clinical Trial

— GASTON  

Official title:

Gastrointestinal Physiological Conditions in Obesity and After Bariatric Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03783052
• Other study ID #: S60930
• Status: Completed
• Phase: N/A
• Start date: February 1, 2018
• Est. completion date: March 30, 2021

Study information

• Verified date: October 2022
• Source: Universitaire Ziekenhuizen KU Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: March 30, 2021
• Est. primary completion date: March 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bariatric Surgery Candidate
• Obesity

Intervention

Device:
• SmartPill in fasted state
SmartPill administration in fasted state
• SmartPill in fed state
SmartPill administration in fed state

Other:
• Aspiration
Aspiration of gastrointestinal samples in fasted and fed state
• Gastric emptying scintigraphy
Gastric emptying scintigraphy in fed state

Locations

Country	Name	City	State
Belgium	UZ Leuven	Leuven

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen KU Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gastrointestinal Temperature	Gastrointestinal Temperature (°C)	0-7 days
Primary	Gastrointestinal pH	Gastrointestinal pH (pH values)	0-7 days
Primary	Gastrointestinal Pressure	Gastrointestinal Pressure (mmHg)	0-7 days
Primary	Concentration of bile acids	Concentration of bile acids	1 day
Primary	Gastric emptying time	Gastric emptying time	2 hours
Secondary	Gastrointestinal motility	Contractions per minute	0-7 days
Secondary	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