Metabolic DiseaseiMACNCT03796000
Characterization of Human Intestinal Macrophages in Metabolic Disease
An observational study of Metabolic Disease, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolic Disease
- What is being tested?
- tissue samples, blood and stool sample
- Type of treatment
- Surgery or procedure
- How many people
- 54 participants
- Where
- 1 siteSwitzerland
- Study dates
- 14 May 2018to 14 May 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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)
Who cannot join
- 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)
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Basel
Basel, Canton of Basel-City, 4031
About this study
Official title: Characterization of Human Intestinal Macrophages in Metabolic Disease - iMAC (Pilot) Study
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.
Read the 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 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.
- Conditions
- Metabolic Disease
- Being tested
- tissue samples, blood and stool sample
- Medical subject headings
- Metabolic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tissue samples, blood and stool sampleProcedure or surgery
Tissue samples from gastroscopy/colonoscopy.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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. Receives: 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 Receives: Procedure: tissue samples, blood and stool sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 2 years
Secondary outcomes (3)
Number of other intestinal immune cells
In case the investigators do not find clear differences in frequency of intestinal macrophages, they will assess other intestinal immune cells (e.g. B-, T-lymphocytes), and enteroendocrine cells (e.g. L-cells) as a secondary endpoint in an explorative manner. Additionally, the investigators aim to correlate their findings from the biopsy samples with inflammation markers and immune cells in the blood, with microbiota and immune cells in the stool and with the eating habits of the patients.
Measured: 2 years
Type and rate of subpopulations of other intestinal immune cells
In case the investigators do not find clear differences in subpopulations of intestinal macrophages, they will assess other intestinal immune cells (e.g. B-, T-lymphocytes), and enteroendocrine cells (e.g. L-cells) as a secondary endpoint in an explorative manner. Additionally, the investigators aim to correlate their findings from the biopsy samples with inflammation markers and immune cells in the blood, with microbiota and immune cells in the stool and with the eating habits of the patients.
Measured: 2 years
Gene expression profile of intestinal macrophages
Gene expression of intestinal macrophages in biopsies from the colon in obese versus lean non-smokers by RNA sequencing.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2019
- Study start14 May 2018
- Primary completion14 Apr 2022
- Study completion14 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Claudia Cavelti, University Hospital, Basel, Switzerland
- Investigators
- Claudia Cavelti-Weder, PD Dr. med., Principal investigator, University Hospital, Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03796000
- Sponsor's protocol ID
- 2018-00712
- Other IDs
- 2018-00712, 2018
- Acronym
- iMAC
- Status last verified
- Jun 2022
- First submitted
- 21 Dec 2018
- Last updated
- 23 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of Human Intestinal Macrophages in Metabolic Disease - iMAC (Pilot) Study
- ClinicalTrials.gov ID
- NCT03796000
- Acronym / sponsor ID
- iMAC / 2018-00712
- Conditions
- Metabolic Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 14 May 2018 (actual)
- Primary completion
- 14 Apr 2022 (actual)
- Study completion
- 14 May 2022 (actual)
- First posted
- 8 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| colonoscopy: obese and smoker | – | Procedure: tissue samples, blood and stool sample* 10 small tissue samples of the Colon transversum * 3 EDTA blood samples and 1 Serum blood sample * in some cases 1 single stool sample |
| colonoscopy: obese and non-smoker | – | Procedure: tissue samples, blood and stool sample* 10 small tissue samples of the Colon transversum * 3 EDTA blood samples and 1 Serum blood sample * in some cases 1 single stool sample |
| colonoscopy: lean and smoker | – | Procedure: tissue samples, blood and stool sample* 10 small tissue samples of the Colon transversum * 3 EDTA blood samples and 1 Serum blood sample * in some cases 1 single stool sample |
| colonoscopy: lean and non-smoker | – | Procedure: tissue samples, blood and stool sample* 10 small tissue samples of the Colon transversum * 3 EDTA blood samples and 1 Serum blood sample * in some cases 1 single stool sample |
| gastroscopy: obese and non-smoker undergoing bariatric surgery | – | Procedure: tissue samples, blood and stool sample* 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. |
| gastroscopy: lean and non-smoker | – | Procedure: tissue samples, blood and stool sample* 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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (8 listed)
- 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)
- Obese (BMI > 35 kg/m2 ) and non-smoker planned for bariatric surgery
Key exclusion criteria (15 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tissue samples, blood and stool sampleTissue samples from gastroscopy/colonoscopy. | Procedure or surgery | 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 |
Primary outcome
Number of intestinal macrophages
Time frame: 2 years
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.
Type and rate of subpopulations of intestinal macrophages
Time frame: 2 years
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.
3 secondary outcomes
Number of other intestinal immune cells
Time frame: 2 years
Type and rate of subpopulations of other intestinal immune cells
Time frame: 2 years
Gene expression profile of intestinal macrophages
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2022.
- Individual participant dataSharing planned: No
Related trials for Metabolic Disease
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
Active, not recruiting
Shockwave™ vs Surgical Endarterectomy for Calcified Severe Common Femoral Artery Stenosis: Comparison of Efficacy, Safety and Long-Term Outcomes
Common Femoral Artery Stenosis, Calcification; Heart
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Not yet recruitingObservational study
Periodontal Status and Biomarkers in MASLD
Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claudia Cavelti-Weder, PD Dr. med. principal investigator
University Hospital, Basel, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metabolic Disease, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of intestinal macrophages (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2022.