The role of intestinal integrity and inflammation in the pathogenesis of insulin resistance and non-alcoholic steatohepatitis in morbid obesity.
Completed
- Conditions
- fatty liver diseaseNAFLDnon-alcoholic steatohepatitis100184241001965410013317
- Registration Number
- NL-OMON33407
- Lead Sponsor
- Medisch Universitair Ziekenhuis Maastricht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 190
Inclusion Criteria
Researchpopulation:
• BMI >40 or BMI>35 kg/m2 with co-morbidities
• planned for bariatric surgery
• Age 18-60 years (to prevent inclusion of patients who are unable to give informed consent and to have inclusion criteria adjusted to the criteria for surgical intervention)
Control population:
• BMI 20-25
• planned for Nissen fundoplication or cholecystectomy
• Age 18-60 years old
Exclusion Criteria
For all patients:
• Age <18 or >60 years
• Diabetes Mellitus type I
• Inflammatory diseases such as auto-immune diseases (due to a higher inflammatory profile)
• Degenerative disase
• Alcohol or drug abuse
• use of corticosteroids and / or prednisolone (confounding effect on inflammatory status)
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary study parameters:<br /><br>•Intestinal permeability, by measurement of excretion of orally administered<br /><br>sugars in urine after intake of ibuprofen (2x400mg)<br /><br>•Plasma endotoxin levels, measured by LAL and ENDOCAB assay<br /><br>•IR/Diabetes type II prevalence, measured by fasted glucose/insulin plasma<br /><br>levels and HbA1c<br /><br>•The extent of NAFLD/ NASH by histopathological stainings of the liver biopsies</p><br>
- Secondary Outcome Measures
Name Time Method