Microbiota inhabiting the small intestine in relation to glycaemic and inflammatory status of morbidly obese subjects.

Completed

• Conditions: obesity; 10018424; 10003018; 10017998; diabetes mellitus

• Registration Number: NL-OMON38923
• Lead Sponsor: Sint Antonius Ziekenhuis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 50

Inclusion Criteria

- BMI> 40 or BMI> 35 kg/m2 with or without co-morbidities
- undergoing hastric bypass surgery
- Age 18-60 years (in line with the indication criteria for bariatric surgery)
- Caucasian race (previous research showed that people of different ethnicity vary in intestinal microbiota composition)

Exclusion Criteria

- Age <18 or> 60 years
- Alcohol abuse (>10 standard international units/week) or any drug use (Cannabis, cocaine, etc)
- Auto-immune and / or inflammatory diseases (eg sarcoidosis, diabetes mellitus type I, liver disease, or intestinal diseases such as inflammatory bowel disease)
- Antibiotics usage <6mnd prior to inclusion (because of their effect on the intestinal microbiota)

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Microbiota composition:<br /><br>- adherent microbiota at site of ileum<br /><br>- luminary small intestinal microbiota composition<br /><br>- faecal microbiota composition<br /><br><br /><br>Insulin resistance (plasma):<br /><br>- Glucose<br /><br>- Insulin<br /><br>- HbA1C<br /><br><br /><br>Inflammation:<br /><br>- CRP (plasma)<br /><br>- histological staining</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- BMI<br /><br>- Diet</p><br>