Obesity, Bariatric Surgery, Gut Microbiome and Immunity Changes

Recruiting

Conditions: Immuunsysteem : veroudering
gut microbiome
Immune system changes
10003018

Registration Number: NL-OMON52532

Lead Sponsor: Maasstadziekenhuis

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 420

Inclusion Criteria

- Age 18 - 65 years
- Body Mass Index >= 35 with the presence of severe comorbidity related to
morbid obesity (diabetes mellitus type 2, obstructive sleep apnoea syndrome
(OSAS), hypertension, etc.) or a BMI >= 40 with or without the presence of
severe comorbidity related to morbid obesity

Exclusion Criteria

- Morbid obesity caused by genetic defects or syndromes
- Perioperative conversion to an open approach

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main endpoint of this study is to determine whether morbid obesity induces<br /><br>premature T cell aging in circulation T cells and whether bariatric surgery<br /><br>halts or reverses obesity-induced effects on T cells (longitudinal setup with<br /><br>follow-up at 3, 6,12 and 18 months postoperative). </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- To determine whether obesity-induced premature T cell aging is also present<br /><br>in adipose tissue, muscle tissue and liver tissue obtained during bariatric<br /><br>surgery.<br /><br><br /><br>- To determine whether the function of the immune system changes after<br /><br>bariatric surgery.<br /><br><br /><br>- To determine whether the gut microbiome changes after bariatric surgery and<br /><br>to compare the change in the gut microbiome to obese individuals not undergoing<br /><br>bariatric surgery but participating in compared lifestyle intervention. </p><br>