Impact of Bariatric Surgery on the Gut Environment (IMPORTUNE)
14 de septiembre de 2021 actualizado por: 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.
Descripción general del estudio
Estado
Terminado
Condiciones
Descripción detallada
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.
Tipo de estudio
De observación
Inscripción (Actual)
151
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
-
-
Vlaams-Brabant
-
Leuven, Vlaams-Brabant, Bélgica, 3000
- University Hospital Leuven
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años a 80 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
N/A
Géneros elegibles para el estudio
Todos
Método de muestreo
Muestra de probabilidad
Población de estudio
- 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.
Descripción
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.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
|---|
|
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
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change from baseline in toxicity of faecal water up to 1 year after bariatric surgery
Periodo de tiempo: 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
Periodo de tiempo: 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
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Degree of fat malabsorption 6-24 months after bariatric surgery
Periodo de tiempo: 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
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Kristin Verbeke, PhD, KU Leuven
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
23 de marzo de 2017
Finalización primaria (Actual)
1 de junio de 2021
Finalización del estudio (Actual)
1 de septiembre de 2021
Fechas de registro del estudio
Enviado por primera vez
10 de abril de 2020
Primero enviado que cumplió con los criterios de control de calidad
10 de abril de 2020
Publicado por primera vez (Actual)
14 de abril de 2020
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
20 de septiembre de 2021
Última actualización enviada que cumplió con los criterios de control de calidad
14 de septiembre de 2021
Última verificación
1 de septiembre de 2021
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- s59836
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .