Characterization of Human Intestinal Macrophages in Metabolic Disease

NCT03796000 | Completed

• 1 other identifier: 2018-00712
• Study Type: observational
• Target: 54
• Locations: 1 country
• Sites: 1

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 disease but its starting point is still unknown, the investigators' aim is to characterize intestinal macrophages from human gut biopsies taken in diagnostic endoscopies of the gastrointestinal tract or in bariatric surgeries for clinical reasons.

Conditions

Metabolic Disease

Outcome Measures

Primary Outcomes (2)

• Number of intestinal macrophages

  Quantity (absolute and relative numbers) of intestinal macrophages in biopsies from the gastrointestinal tract in obese versus lean subjects and smokers versus non-smokers measured with flow cytometry.

  2 years

• Type and rate of subpopulations of intestinal macrophages

  Quality (inflammatory versus non-inflammatory subpopulations) of intestinal macrophages in biopsies from the gastrointestinal tract in obese versus lean subjects and smokers versus non-smokers measured with flow cytometry.

  2 years

Secondary Outcomes (3)

• Number of other intestinal immune cells

  2 years

• Type and rate of subpopulations of other intestinal immune cells

  2 years

• Gene expression profile of intestinal macrophages

  2 years

Study Arms (6)

colonoscopy: obese and smoker

* 10 small tissue samples of the Colon transversum * 3 EDTA blood samples and 1 Serum blood sample * in some cases 1 single stool sample

Procedure: tissue samples, blood and stool sample

colonoscopy: obese and non-smoker

* 10 small tissue samples of the Colon transversum * 3 EDTA blood samples and 1 Serum blood sample * in some cases 1 single stool sample

Procedure: tissue samples, blood and stool sample

colonoscopy: lean and smoker

* 10 small tissue samples of the Colon transversum * 3 EDTA blood samples and 1 Serum blood sample * in some cases 1 single stool sample

Procedure: tissue samples, blood and stool sample

colonoscopy: lean and non-smoker

* 10 small tissue samples of the Colon transversum * 3 EDTA blood samples and 1 Serum blood sample * in some cases 1 single stool sample

Procedure: tissue samples, blood and stool sample

gastroscopy: obese and non-smoker undergoing bariatric surgery

* 6 small tissue samples of the gastric corpus and 6 of the Duodenum * 3 EDTA blood samples and 1 Serum blood sample * in some cases 1 single stool sample * 1cm long piece of the jejunum, which is usually disposed during bariatric surgery.

Procedure: tissue samples, blood and stool sample

gastroscopy: lean and non-smoker

* 6 small tissue samples of the gastric corpus and 6 of the Duodenum * 3 EDTA blood samples and 1 Serum blood sample * in some cases 1 single stool sample

Procedure: tissue samples, blood and stool sample

Interventions

tissue samples, blood and stool sample PROCEDURE

Tissue samples from gastroscopy/colonoscopy.

colonoscopy: lean and non-smoker; colonoscopy: lean and smoker; colonoscopy: obese and non-smoker; colonoscopy: obese and smoker; gastroscopy: lean and non-smoker; gastroscopy: obese and non-smoker undergoing bariatric surgery

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All patients planned for diagnostic endoscopy of the gastrointestinal tract or bariatric surgery at the University Hospital of Basel, the doctor's Office MagenDarm Basel or the Department of Visceral Surgery, Hospital Lindenhof of Bern will be screened for study participation, contacted and informed about the study if suitable to all inclusion and exclusion criterias.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

University Hospital Basel

Basel, Canton of Basel-City, 4031, Switzerland

Location

MeSH Terms

Conditions

Metabolic Diseases

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Claudia Cavelti-Weder, PD Dr. med.

  University Hospital, Basel, Switzerland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: private lecturer

Study Record Dates

• First Submitted: December 21, 2018
• First Posted: January 8, 2019
• Study Start: May 14, 2018
• Primary Completion: April 14, 2022
• Study Completion: May 14, 2022
• Last Updated: June 23, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)