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Impact of Bariatric Surgery on the Gut Environment (IMPORTUNE)

14 september 2021 bijgewerkt door: Kristin Verbeke, KU Leuven

Impact of the Bacterial Colonial Metabolism on Fecal Water Toxicity as Biomarkers of Future Colorectal Cancer Risk After Bariatric Surgery

The purpose of this study is to investigate the impact of bariatric surgery on the gut health. Patients operated with Roux-en-Y gastric bypass or sleeve gastrectomy and obese patients who want too loose weight with a traditional weight-loss program, will be followed up for 1 year. In these patients, the investigators will measure toxicity parameters to understand better the health status of their colon after surgery. In a next phase, the measured toxicity will be linked with certain players that might cause this toxicity. Protein metabolites, formed from undigested protein by microbiota in the colon, are expected to be toxic agents for the colon. Therefore, the investigators will investigate the fate of ingested protein once the surgery patients are metabolically stabilized.

Studie Overzicht

Toestand

Voltooid

Conditie

Kandidaat Bariatrische Chirurgie

Gedetailleerde beschrijving

To quantify protein assimilation after bariatric surgery, the investigators will perform in bariatric surgery patients (Roux-en- Y gastric bypass and Sleeve Gastrectomy) and in a control group a cross-sectional study with a single test day. On the test day, the study participants will consume a test meal that contains intrinsically labelled egg proteins and will take a capsule with 14C-glycocholic acid and a capsule with 3H-labelled polyethylene glycol. Participants will record a food diary 72h before and after the test day and during the test collect breath samples for 6h. Urine and stool will be collected respectively up to 24h and 72h after consumption of the test meal.

For the 1-year follow up study, the 3 patient groups (Roux-en-Y gastric bypass, Sleeve gastrectomy and control group with traditional weight loss therapy) will have 5 visits, a baseline visit and 4 visits after surgery or after starting traditional therapy. The time points after baseline include 2 weeks, 3 months, 6 months and 12 months. Each visit, a blood and stool sample will be collected, a 7-day food and stool diary will be registered and also weight loss will be recorded.

Studietype

Observationeel

Inschrijving (Werkelijk)

151

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

België
- Vlaams-Brabant
  - Leuven, Vlaams-Brabant, België, 3000
    - University Hospital Leuven

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar tot 80 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

NVT

Geslachten die in aanmerking komen voor studie

Allemaal

Bemonsteringsmethode

Kanssteekproef

Studie Bevolking

Surgery patient group was recruited at the University Hospital Leuven.
Obese control group was recruited at the Obesity Clinic of the University Hospital Leuven.
Normal and overweight control group was recruited among the employees and family members from employees of the University Hospital Leuven.

Beschrijving

Inclusion Criteria:

Surgery patients (toxicity and protein assimilation) : BMI > 40 kg/m² or > 35 kg/m² if combined with either obstructive sleep apnoea syndrome, high blood pressure not controllable with 3 different medications or type II diabetes, (3) exclusion of other underlying causes of obesity by an endocrinologist, (4) having tried to lose weight on a non-surgical way for at least 1 year without result and (5) a positive advice from a multidisciplinary team consisting of a surgeon, endocrinologist, psychologist and dietitian.
Obese control group in weight loss program (toxicity) : obese but otherwise healthy patients on a weight loss diet (BMI > 30 kg/m²) in the context of the weight-loss program organised at the Obesity Clinic of University Hospital Leuven.
Control group (protein assimilation) : normal weight (BMI 25-30 kg/m²) or overweight (BMI 25-30 kg/m²).

Exclusion Criteria:

Intake of antibiotics 1 months before the start of the study. Pre-and probiotics, laxatives and anti-diarrhea drugs 2 weeks before the start of the study.
Surgery patients and control group (toxicity) : Gastrointestinal disease or major abdominal surgery in the past (except from appendectomy and cholecystectomy).
Surgery patients and control group (protein assimilation) : Lung, liver, kidney and gastrointestinal disease or major abdominal surgery in the past (except from appendectomy, cholecystectomy and bariatric surgery). Vegan, vegetarian, lactose-or gluten-free diet. Pregnant or lactating women and subjects who participated in the last year in a study with irradiation exposure.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Aantal groepen / cohorten

Cohorten en interventies

Groep / Cohort
Roux-en-Y gastric bypass Patients who were planned for surgery with Roux-en-Y gastric bypass and were operated
Sleeve Gastrectomy Patients who were planned for surgery with Sleeve Gastrectomy and were operated
Control group Obese patients involved in a weight loss program that focuses on diet and lifestyle changes

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat	Maatregel Beschrijving	Tijdsspanne
Change from baseline in toxicity of faecal water up to 1 year after bariatric surgery Tijdsspanne: Baseline and 2 weeks, 3 months, 6 months and 1 year after surgery	Faecal water toxicity : measured with a cell viability test. Toxicity : expressed as the dilution of faecal water at which 50 percent of the cells survive.	Baseline and 2 weeks, 3 months, 6 months and 1 year after surgery
Degree of protein assimilation 6-24 months after bariatric surgery Tijdsspanne: 6-24 months after surgery	Protein digestion, malabsorption and fermentation : assessed with stable isotope technology. Digestion and malabsorption : expressed as percent of the administered isotope dose. Fermentation : expressed as percent of maximal dose of the fermentation product that can be formed.	6-24 months after surgery

Secundaire uitkomstmaten

Uitkomstmaat	Maatregel Beschrijving	Tijdsspanne
Degree of fat malabsorption 6-24 months after bariatric surgery Tijdsspanne: 6-24 months after surgery	Malabsorption of fat : calculated as ((fat intake- fat excretion)/fat intake)*100%, expressed as coefficient of fat absorption. Excretion : measured with the Van de Kamer method.	6-24 months after surgery

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

KU Leuven

Onderzoekers

Hoofdonderzoeker: Kristin Verbeke, PhD, KU Leuven

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

23 maart 2017

Primaire voltooiing (Werkelijk)

1 juni 2021

Studie voltooiing (Werkelijk)

1 september 2021

Studieregistratiedata

Eerst ingediend

10 april 2020

Eerst ingediend dat voldeed aan de QC-criteria