Bariatric Surgery, Obesity & Overweight, Roux-en Y Gastric Bypass, Sleeve Gastrectomy
Conditions
Keywords
Gastro-intestinal aspiration, ingestible telemetric capsule
Brief summary
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.
Detailed description
This clinical trial aims to characterize gastric and pancreatic enzyme activity in adults aged 18 to 65 who have previously (at least 1 year ago) undergone Roux-en-Y gastric bypass (RYGB) or sleeve gastrectomy (SG), as well as in individuals with obesity. In addition, the study seeks to quantify bile acid concentrations and pH at various locations within the gastrointestinal tract and to assess gastrointestinal transit time. During the study, aspirates will be collected from multiple regions of the gastrointestinal tract using a naso-intestinal catheter (study visit 1). An ingestible capsule will also be used to obtain continuous in vivo measurements of physiological conditions along the entire gastrointestinal tract (study visit 2).
Interventions
OTHERGastro-intestinal aspiration
Aspiration of fluids from the stomach and small intestine using a naso-intestinal catheter.
DEVICETelemetric
Telemetric ingestible capsule
Sponsors
Universitaire Ziekenhuizen KU Leuven
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
Participants eligible for inclusion in this Investigation have to meet all of the following criteria: 1. Voluntary written informed consent of the participant has been obtained prior to any screening procedures 2. Age: 18-65 years Specific inclusion criteria for the different patient populations: Patients with obesity: 3. Body Mass Index: \> 30 kg/m2 Patients after bariatric surgery: 4. Surgery: at least one year after Roux-en-Y gastric bypass or sleeve gastrectomy
Exclusion criteria
Participants eligible for this Investigation must not meet any of the following criteria: 1. Patient has history of more than one bariatric surgery 2. Patient has a waist circumference \> 125.6 cm 3. Patient had gastrointestinal surgery in the past three months 4. Patient has a pacemaker, defibrillator, infusion pump, or other portable or implanted electromedical device 5. Patient had frequent exposure to X-rays in the past year 6. Patient has swallowing disorders, among others: dysphagia for food or pills, any oropharyngeal or oesophageal stricture, anxiety or functional abnormality 7. Patient has Crohn's disease or Diverticulitis 8. Patient has gastrointestinal strictures, fistulas or physiological/mechanical obstructions 9. Patient has gastric bezoar 10. Patient has a history of complex bowel resection or known abdominal adhesions 11. Patient has short bowel syndrome or ostomy 12. Patient has currently ongoing infections 13. Patient is planned to undergo usage of rectal foam/enema or treatment with adjuvant chemotherapy or radiotherapy 14. Patient is currently on parenteral diet 15. Patient is planned to undergo MRI procedure during usage of the wireless capsule 16. Patient is working in a professional healthcare facility (e.g. hospital, dental office, emergency room), military area (e.g. submarine, near radar installation), or heavy industrial area (e.g. power plants, automotive, mining, refineries) during the duration of the clinical investigation 17. Patient is pregnant, breastfeeding, actively trying to get pregnant or had recent childbirth in last 6 months 18. Patient cannot discontinue medication that affects gastrointestinal transit time and/or pH for at least 3 days before and during the study (and 4 weeks for weekly/long-acting GLP-1 analogues such as Saxenda, Ozempic, Wegovy, Mounjaro). This includes opioids (e.g., morphine, codeine), proton pump inhibitors (e.g., omeprazole, esomeprazole, pantoprazole), H2-receptor antagonists (e.g., cimetidine, famotidine), antacids, sucralfate, prokinetics (e.g., domperidone, metoclopramide), antidiarrheal agents (e.g., loperamide), antibiotics, probiotics and prebiotics. 19. Any disorder, which in the investigator's opinion might jeopardise participant's safety or compliance with the CIP.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Activity of gastric lipase | 2 hours | Gastric pouch and sleeve samples will be analysed for gastric lipase activity (described in U) |
| Activity of pepsin | 2 hours | Gastric pouch and sleeve samples will be analysed for pepsin activity (described in U) |
| Activity of trypsin | 2 hours | Samples collected in the duodenum and jejunum; or roux- and common-limb will be analysed for trypsin activity (described in U). |
| Activity of chymotrypsin | 2 hours | Samples collected in the duodenum and jejunum; or roux- and common-limb will be analysed for chymotrypsin activity (described in U). |
| Activity of α-amylase | 2 hours | Samples collected in the duodenum and jejunum; or roux- and common-limb will be analysed for α-amylase activity (described in U). |
| Activity of pancreatic lipase | 2 hours | Samples collected in the duodenum and jejunum; or roux- and common-limb will be analysed for pancreatic lipase activity (described in U). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Concentration of total bile acids | 2 hours | The total bile acid concentrations will be measured in all samples |
| pH | 2 hours | pH will be measured in all gastro-intestinal samples |
| Total transit time | 48 hours | Total transit time will be measured by the GISMO GEN I ingestible sensor (described in minutes). |
| Gastric emptying time | 48 hours | Gastric emptying time will be measured by the GISMO GEN I ingestible sensor (described in minutes). |
| Small intestinal transit time | 48 hours | Small intestinal transit time will be measured by the GISMO GEN I ingestible sensor (described in minutes). |
| Large intestinal transit time | 48 hours | Large intestinal transit time will be measured by the GISMO GEN I ingestible sensor (described in minutes). |
Countries
Netherlands
Contacts
CONTACTMaaike De Kreek, MSc
CONTACTBart Van der Schueren, Prof. Dr.
Outcome results
None listed