Characterization of Human Intestinal Macrophages in Metabolic Disease

Status Completed

Clinical Trial 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.

Clinical Trial 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 pollution have also emerged as unexpected risk factors for type 2 Diabetes. Inflammation has been reported as key characteristic of metabolic disease and is predictive of future cardiovascular events. However, the starting point of chronic low-grade inflammation is not known. As the gastrointestinal tract first comes into contact with dietary components, but potentially also air pollution/ smoke particles ingested upon mucociliary clearance from the lung, the gut could be the starting point of inflammation in metabolic disease. The aim of this study is to characterize intestinal macrophages in obese versus lean subjects and smokers versus non-smokers to translate the principal investigator's preclinical findings to human disease and assess whether an inflammatory shift prevails in human intestinal macrophages in metabolic disease. Additionally, to assess whether intestinal macrophage subpopulations can be altered deliberately by nutritional intervention, the investigators will assess intestinal macrophages from subjects scheduled for bariatric surgery that will be on a calorie-restricted diet during the last 2 to 4 weeks prior to surgery. The macrophages originate from human gut samples. As patients will undergo diagnostic endoscopy of the gastrointestinal tract or bariatric surgery for clinical reasons and the standard of care will not be changed by the study, there will be no additional interventions to patients by their participation in the study. Additionally, three EDTA and one serum blood tube for the analysis of inflammatory cells and markers in the blood will be taken as well as a single stool sample. The investigators' goal is to recruit in total 150 patients as it will be a pilot study in a first step. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03796000
Study type	Observational
Source	University Hospital, Basel, Switzerland
Contact
Status	Completed
Phase
Start date	May 14, 2018
Completion date	May 14, 2022

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Characterization of Human Intestinal Macrophages in Metabolic Disease — iMAC

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms