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| ID | Type | Description | Link |
|---|---|---|---|
| CIV-25-08-054154 | Other Identifier | AFMPS - FAGG |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Roux-en-Y gastric bypass | Patients who had undergone Roux-en-Y gastric bypass surgery |
| |
| Sleeve gastrectomy | Patients who had undergone sleeve gastrectomy surgery |
| |
| Patients living with obesity | Patients without previous bariatric surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gastro-intestinal aspiration | Other | Aspiration of fluids from the stomach and small intestine using a naso-intestinal catheter. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Activity of gastric lipase | Gastric pouch and sleeve samples will be analysed for gastric lipase activity (described in U) | 2 hours |
| Activity of pepsin | Gastric pouch and sleeve samples will be analysed for pepsin activity (described in U) | 2 hours |
| Activity of trypsin | Samples collected in the duodenum and jejunum; or roux- and common-limb will be analysed for trypsin activity (described in U). | 2 hours |
| Activity of chymotrypsin | Samples collected in the duodenum and jejunum; or roux- and common-limb will be analysed for chymotrypsin activity (described in U). | 2 hours |
| Activity of α-amylase | Samples collected in the duodenum and jejunum; or roux- and common-limb will be analysed for α-amylase activity (described in U). | 2 hours |
| Activity of pancreatic lipase | Samples collected in the duodenum and jejunum; or roux- and common-limb will be analysed for pancreatic lipase activity (described in U). | 2 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Concentration of total bile acids | The total bile acid concentrations will be measured in all samples | 2 hours |
| pH | pH will be measured in all gastro-intestinal samples |
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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:
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Patients who have previously undergone a RYGB surgery, SG surgery, or people with obesity.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Maaike De Kreek, MSc | Contact | +32 16 34 72 89 | maaike.dekreek@kuleuven.be | |
| Bart Van der Schueren, Prof. Dr. | Contact |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitaire Ziekenhuizen KU Leuven | Recruiting | Leuven | 3000 | Netherlands |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| Telemetric | Device | Telemetric ingestible capsule |
|
| 2 hours |
| Total transit time | Total transit time will be measured by the GISMO GEN I ingestible sensor (described in minutes). | 48 hours |
| Gastric emptying time | Gastric emptying time will be measured by the GISMO GEN I ingestible sensor (described in minutes). | 48 hours |
| Small intestinal transit time | Small intestinal transit time will be measured by the GISMO GEN I ingestible sensor (described in minutes). | 48 hours |
| Large intestinal transit time | Large intestinal transit time will be measured by the GISMO GEN I ingestible sensor (described in minutes). | 48 hours |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |