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Impact of Bariatric Surgery on the Gut Environment (IMPORTUNE)

14 de setembro de 2021 atualizado 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.

Visão geral do estudo

Status

Concluído

Condições

Candidato à Cirurgia Bariátrica

Descrição detalhada

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 estudo

Observacional

Inscrição (Real)

151

Contactos e Locais

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Locais de estudo

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

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos a 80 anos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

N/D

Gêneros Elegíveis para o Estudo

Tudo

Método de amostragem

Amostra de Probabilidade

População do estudo

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.

Descrição

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.

Plano de estudo

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Como o estudo é projetado?

Detalhes do projeto

Número de grupos/coortes

Coortes e Intervenções

Grupo / Coorte
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

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado	Descrição da medida	Prazo
Change from baseline in toxicity of faecal water up to 1 year after bariatric surgery Prazo: 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 Prazo: 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 resultados secundários

Medida de resultado	Descrição da medida	Prazo
Degree of fat malabsorption 6-24 months after bariatric surgery Prazo: 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

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

KU Leuven

Investigadores

Investigador principal: Kristin Verbeke, PhD, KU Leuven

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

23 de março de 2017

Conclusão Primária (Real)

1 de junho de 2021

Conclusão do estudo (Real)

1 de setembro de 2021

Datas de inscrição no estudo

Enviado pela primeira vez

10 de abril de 2020

Enviado pela primeira vez que atendeu aos critérios de CQ