Status:
COMPLETED
Characterization of Human Intestinal Macrophages in Metabolic Disease
Lead Sponsor:
University Hospital, Basel, Switzerland
Conditions:
Metabolic Disease
Eligibility:
All Genders
18-80 years
Brief Summary
This is a prospective, observational study aiming at improving the understanding of the pathophysiology of metabolic disease. As inflammation has been recognized as a key characteristic of metabolic d...
Detailed Description
Metabolic disease including obesity and diabetes has reached epidemic proportions in the past years. Besides classical risk factors such as unhealthy diet and physical inactivity, smoking and air poll...
Eligibility Criteria
Inclusion
- Patient undergoing colonoscopy:
- Obese (BMI \> 32 kg/m2 ) and smoker (≥ 1 pack cigarettes/d)
- Obese (BMI \> 32 kg/m2 ) and non-smoker (control group)
- Lean (BMI \< 27 kg/m2 ) and smoker (≥ 1 pack cigarettes/d)
- Lean (BMI \< 27 kg/m2 ) and non-smoker (control group)
- Patient undergoing gastroscopy:
- Obese (BMI \> 35 kg/m2 ) and non-smoker planned for bariatric surgery
- Lean (BMI \< 27 kg/m2 ) and non-smoker (control group)
Exclusion
- Inability to provide informed consent, e.g. mental impairment or insufficient knowledge of project language
- Intake of corticosteroids
- Anti-inflammatory/ immunosuppressive drugs
- Clinical signs of current infection
- Known anemia (e.g. hemoglobin \< 110 g/L for males, \< 100 g/L for females)
- Known neutropenia (e.g. leukocyte count \< 1.5 × 10\^9/L or ANC \< 0.5 × 10\^9/L)
- Known immunodeficiency, e.g. HIV
- Known vasculitis, collagenosis
- Known inflammatory bowel disease
- Known adrenal insufficiency and/or substitution with glucocorticoids
- Known clinically significant kidney or liver disease (e.g. creatinine \> 1.5 mg/dL, AST/ALT \> 2 × ULN, alkaline phosphatase \> 2 × ULN, or total bilirubin \[tBili\] \> 1.5 × ULN)
- Risky daily alcohol consumption (\> 24g/d for males, \> 12g for females), known liver cirrhosis Child B or C
- Known uncontrolled congestive heart failure
- Known uncontrolled malignant disease
- Currently pregnant or breastfeeding
Key Trial Info
Start Date :
May 14 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 14 2022
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT03796000
Start Date
May 14 2018
End Date
May 14 2022
Last Update
June 23 2022
Active Locations (1)
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1
University Hospital Basel
Basel, Canton of Basel-City, Switzerland, 4031