Gastro-Intestinal Digestion and Physiology After Bariatric Surgery
Overview
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 51
- Locations
- 1
- Primary Endpoint
- Activity of gastric lipase
Overview
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).
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Cross Sectional
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Participants eligible for inclusion in this Investigation have to meet all of the following criteria:
- •Voluntary written informed consent of the participant has been obtained prior to any screening procedures
- •Age: 18-65 years
- •Specific inclusion criteria for the different patient populations:
- •Patients with obesity:
- •Body Mass Index: \> 30 kg/m2
- •Patients after bariatric surgery:
- •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:
- •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
- •Patient had frequent exposure to X-rays in the past year
- •Patient has swallowing disorders, among others: dysphagia for food or pills, any oropharyngeal or oesophageal stricture, anxiety or functional abnormality
- •Patient has Crohn's disease or Diverticulitis
- •Patient has gastrointestinal strictures, fistulas or physiological/mechanical obstructions
- •Patient has gastric bezoar
Outcomes
Primary Outcomes
Activity of gastric lipase
Time Frame: 2 hours
Gastric pouch and sleeve samples will be analysed for gastric lipase activity (described in U)
Activity of pepsin
Time Frame: 2 hours
Gastric pouch and sleeve samples will be analysed for pepsin activity (described in U)
Activity of trypsin
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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 Outcomes
- Concentration of total bile acids(2 hours)
- pH(2 hours)
- Total transit time(48 hours)
- Gastric emptying time(48 hours)
- Small intestinal transit time(48 hours)
- Large intestinal transit time(48 hours)