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Impact of Bariatric Surgery on the Gut Environment (IMPORTUNE)

14. September 2021 aktualisiert von: 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.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Kandidat für bariatrische Chirurgie

Detaillierte Beschreibung

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.

Studientyp

Beobachtungs

Einschreibung (Tatsächlich)

151

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre bis 80 Jahre (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

N/A

Studienberechtigte Geschlechter

Alle

Probenahmeverfahren

Wahrscheinlichkeitsstichprobe

Studienpopulation

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.

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

Anzahl der Gruppen / Kohorten

Kohorten und Interventionen

Gruppe / Kohorte
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

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme	Maßnahmenbeschreibung	Zeitfenster
Change from baseline in toxicity of faecal water up to 1 year after bariatric surgery Zeitfenster: 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 Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme	Maßnahmenbeschreibung	Zeitfenster
Degree of fat malabsorption 6-24 months after bariatric surgery Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

KU Leuven

Ermittler

Hauptermittler: Kristin Verbeke, PhD, KU Leuven

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

23. März 2017

Primärer Abschluss (Tatsächlich)

1. Juni 2021

Studienabschluss (Tatsächlich)

1. September 2021

Studienanmeldedaten

Zuerst eingereicht

10. April 2020

Zuerst eingereicht, das die QC-Kriterien erfüllt hat