Gastro-Intestinal Digestion and Physiology After Bariatric Surgery
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorUniversitaire Ziekenhuizen KU Leuven
About this trial
The goal of this clinical trial is to characterize gastrointestinal digestion and physiology in patients after bariatric surgery, or people living with obesity. The main question it aims to answer is: what is the status of gastrointestinal digestion and physiology after bariatric surgery? Participants will have two study visits: 1) participants will undergo collection of gastrointestinal samples and 2) participants will ingest an ingestible capsule that measures multiple physiological parameters along the gastrointestinal tract.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Voluntary written informed consent of the participant has been obtained prior to any screening procedures
Age: 18-65 years
Body Mass Index: > 30 kg/m2
Surgery: at least one year after Roux-en-Y gastric bypass or sleeve gastrectomy
Disqualifiers
Patient has history of more than one bariatric surgery
Patient has a waist circumference > 125.6 cm
Patient had gastrointestinal surgery in the past three months
Patient has a pacemaker, defibrillator, infusion pump, or other portable or implanted electromedical device
Trial population
Patients who have previously undergone a RYGB surgery, SG surgery, or people with obesity.
Trial design
Design model
Cohort
Time perspective
Cross-sectional
Treatments tested in this trial
Gastro-intestinal aspiration
Other interventionAspiration of fluids from the stomach and small intestine using a naso-intestinal catheter.
Telemetric
DeviceTelemetric ingestible capsule
Treatment groups
51 Participants
are divided into 3 treatment groupsGroup A: Roux-en-Y gastric bypass2 interventions
Group B: Sleeve gastrectomy2 interventions
Group C: Patients living with obesity2 interventions
Trial outcomes
Primary outcomes
1
Activity of gastric lipase
Gastric pouch and sleeve samples will be analysed for gastric lipase activity (described in U)
Time frame
2 hours2
Activity of pepsin
Gastric pouch and sleeve samples will be analysed for pepsin activity (described in U)
Time frame
2 hours3
Activity of trypsin
Samples collected in the duodenum and jejunum; or roux- and common-limb will be analysed for trypsin activity (described in U).
Time frame
2 hours4
Activity of chymotrypsin
Samples collected in the duodenum and jejunum; or roux- and common-limb will be analysed for chymotrypsin activity (described in U).
Time frame
2 hoursSecondary outcomes
1
Concentration of total bile acids
The total bile acid concentrations will be measured in all samples
Time frame
2 hours2
pH
pH will be measured in all gastro-intestinal samples
Time frame
2 hours3
Total transit time
Total transit time will be measured by the GISMO GEN I ingestible sensor (described in minutes).
Time frame
48 hours4
Gastric emptying time
Gastric emptying time will be measured by the GISMO GEN I ingestible sensor (described in minutes).
Time frame
48 hoursSponsors and contacts
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Source ClinicalTrials.gov