InflammationINFONCT06752018
Inflammation's Impact on Heart Disease and Diabetes
An observational study of Inflammation and Obesity and Type 2 Diabetes, run by University of Aarhus at 1 site in Denmark.
Trial summary
The goal of this observational study is to evaluate the inflammatory response associated with cardiometabolic diseases, and whether these can be reduced by ex vivo treatment with therapeutic agents. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Inflammation, Obesity and Type 2 Diabetes, Obesity
- What is being tested?
- Gastric bypass
- Type of treatment
- Surgery or procedure
- How many people
- 250 participants
- Where
- 1 siteDenmark
- Study dates
- 30 Jan 2025to Dec 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy controls and obese patients, scheduled to undergo bariatric surgery without a pre-surgical diet
Who may be able to join
- Individuals willing and able to give appropriate oral and written informed consent
- Men and women over 18 years of age.
- Correct body mass index (BMI) (Lean controls: 18.5-24.9 kg/m2. Obese gastric bypass patients: 35-50 kg/m2)
Who cannot join
- The individual does not follow instructions given in the research study.
- Pregnancy.
- Significant gastrointestinal problems.
- Use of tobacco.
- The individual consumed alcohol within two days prior to the study visit
- Active cancer within 5 years.
Show all 11Show fewer
- Use of dietary supplements that impact the inflammatory resolution process (e.g., fish oils), and the person is not willing to discontinue the use of the supplements 1 week prior to the visits.
- Underlying cardiometabolic disease, or medication related to such disease (e.g., blood pressure medication, insulin to treat diabetes, etc.).
- Underlying inflammatory disease, or medication related to such disease.
- The individual states that they have increased bleeding tendency or are using anti-coagulant (blood-thinning) medication.
- For obese patients only: The individual has lost more than 8% of his/her body weight since their clinical referral for surgery or has lost more than 3% of his/her body weight in the 4 months leading up to surgery.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Steno Diabetes Center Aarhus
Aarhus, 8200
Emma Börgeson, PhD, associate professor, +45 9352 2984, emma.borgeson@biomed.au.dk
About this study
Official title: Inflammation: a Key Contributor to Heart Disease and Diabetes?
The goal of this observational study is to evaluate the inflammatory response associated with cardiometabolic diseases, and whether these can be reduced by ex vivo treatment with therapeutic agents. Briefly, the study involves two populations: healthy volunteers and severely obese patients undergoing weight-loss surgery. The main questions the study seeks to address are:
- To investigate if the therapeutic agents modulate the inflammatory response linked to obesity and cardiometabolic disease?
- What underlying factors contribute to variations in individual responses?
Read more
Researchers will examine differences between healthy participants and those undergoing weight-loss surgery to assess the potential impact of weight loss on responsiveness and overall outcomes.
Participants will:
- Undergo initial testing to evaluate their baseline response.
- Provide samples during surgery for further analysis.
- Participate in follow-up assessments to track changes over time.
Read the detailed description
The goal of this observational study is to investigate the relationship between treatment responsiveness and inflammation both systemically in blood, and peripherally in tissue biopsies, focusing on its relevance to cardiometabolic disease and associated conditions. The study aims to develop a predictive model to identify individuals most likely to benefit from anti-inflammatory treatments, thus supporting personalized therapeutic strategies.
Main research questions:
- To investigate if the therapeutic agents modulate the inflammatory response linked to obesity and cardiometabolic disease
- To determine the underlying factors that contribute to variations in individual responses to anti-inflammatory drugs
Study design:
The study will involve two participant groups:
- Healthy control group, composedrised of normal weight individuals
- Obese adult patients, scheduled to undergo bariatric surgery.
Participant procedures:
- Baseline testing: An initial test will evaluate treatment responsiveness.
- Tissue sampling: Tissue biopsies are obtained during surgery and undergo detailed analyses, including ex vivo treatments
- Follow-up assessments: Participants will be reassessed a year after surgery to evaluate long-term outcomes.
Methods:
- Molecular studies: Whole blood and peripheral tissue biopsies (adipose tissue, liver, muscle and intestinal biopsies) will be analyzed to identify cellular and molecular pathways associated with treatment responsiveness.
- Predictive modeling: Clinical, molecular, and biochemical data will be integrated to create a model predicting individual responsiveness.
- Insulin sensitivity analysis: Advanced imaging techniques will measure tissue-specific glucose uptake.
Hypotheses: Impaired ability to regulate the inflammatory response correlates with cardiometabolic disease.
Anticipated Outcomes:
The study seeks to support precision medicine approaches for addressing cardiometabolic disease.
This research builds on previous findings about the role of inflammation in cardiometabolic dysfunction. By differentiating responders from non-responders, the study aims to support targeted therapeutic strategies for inflammation and cardiometabolic health.
- Conditions
- Inflammation, Obesity and Type 2 Diabetes, Obesity, Metabolic Syndrome, Anti-Inflammatory Agents
- Being tested
- Gastric bypass
- Keywords
- Disease, Overweight, overnutrition, body weight, Insulin resistance, Inflammation, Anti-Inflammatory Agents
- Medical subject headings
- Inflammation, Obesity, Diabetes Mellitus, Type 2, Metabolic Syndrome, Disease, Overweight, Overnutrition, Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gastric bypassProcedure or surgery
Roux-en-Y gastric bypass or sleeve gastrectomy
| Study group | Role | What they receive |
|---|---|---|
| Obese gastric bypass patients | Not described Receives: Procedure: Gastric bypass | |
| Lean healthy controls | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Whole blood ROS prooduction
The primary endpoint of the study is the therapeutic agent-induced reduction in reactive oxygen species (ROS) production in whole blood, following stimulation with N-Formylmethionyl-leucyl-phenylalanine (fMLP), escherichia coli (E. coli), and phorbol myristate acetate (PMA).
Measured: At baseline and 1 year post surgery
Whole blood ROS production
The primary endpoint of the study is the therapeutic agent-induced reduction in ROS production in whole blood, following stimulation with fMPL, E. coli, or PMA
Measured: At the time of enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2024
- Study start30 Jan 2025
- Primary completionDec 2030 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InflammationStudies of the same condition, open and under way.
- More trials run by University of AarhusThe 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
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emma Börgeson, Dr., PhD, MSc, Principal investigator, University of Aarhus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06752018
- Sponsor's protocol ID
- 1-10-72-91-24
- Acronym
- INFO
- Status last verified
- Dec 2024
- First submitted
- 20 Dec 2024
- Last updated
- 3 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inflammation: a Key Contributor to Heart Disease and Diabetes?
- ClinicalTrials.gov ID
- NCT06752018
- Acronym / sponsor ID
- INFO / 1-10-72-91-24
- Conditions
- Inflammation, Obesity and Type 2 Diabetes, Obesity, Metabolic Syndrome, Anti-Inflammatory Agents
- Keywords
- Disease, Overweight, overnutrition, body weight, Insulin resistance, Inflammation, Anti-Inflammatory Agents
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- 30 Jan 2025 (actual)
- Primary completion
- Dec 2030 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 30 Dec 2024 (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.
The goal of this observational study is to evaluate the inflammatory response associated with cardiometabolic diseases, and whether these can be reduced by ex vivo treatment with therapeutic agents. Briefly, the study involves two populations: healthy volunteers and severely obese patients undergoing weight-loss surgery. The main questions the study seeks to address are:
- To investigate if the therapeutic agents modulate the inflammatory response linked to obesity and cardiometabolic disease?
- What underlying factors contribute to variations in individual responses?
Researchers will examine differences between healthy participants and those undergoing weight-loss surgery to assess the potential impact of weight loss on responsiveness and overall outcomes.
Participants will:
- Undergo initial testing to evaluate their baseline response.
- Provide samples during surgery for further analysis.
- Participate in follow-up assessments to track changes over time.
Detailed description
The goal of this observational study is to investigate the relationship between treatment responsiveness and inflammation both systemically in blood, and peripherally in tissue biopsies, focusing on its relevance to cardiometabolic disease and associated conditions. The study aims to develop a predictive model to identify individuals most likely to benefit from anti-inflammatory treatments, thus supporting personalized therapeutic strategies.
Main research questions:
- To investigate if the therapeutic agents modulate the inflammatory response linked to obesity and cardiometabolic disease
- To determine the underlying factors that contribute to variations in individual responses to anti-inflammatory drugs
Study design:
The study will involve two participant groups:
- Healthy control group, composedrised of normal weight individuals
- Obese adult patients, scheduled to undergo bariatric surgery.
Participant procedures:
- Baseline testing: An initial test will evaluate treatment responsiveness.
- Tissue sampling: Tissue biopsies are obtained during surgery and undergo detailed analyses, including ex vivo treatments
- Follow-up assessments: Participants will be reassessed a year after surgery to evaluate long-term outcomes.
Methods:
- Molecular studies: Whole blood and peripheral tissue biopsies (adipose tissue, liver, muscle and intestinal biopsies) will be analyzed to identify cellular and molecular pathways associated with treatment responsiveness.
- Predictive modeling: Clinical, molecular, and biochemical data will be integrated to create a model predicting individual responsiveness.
- Insulin sensitivity analysis: Advanced imaging techniques will measure tissue-specific glucose uptake.
Hypotheses: Impaired ability to regulate the inflammatory response correlates with cardiometabolic disease.
Anticipated Outcomes:
The study seeks to support precision medicine approaches for addressing cardiometabolic disease.
This research builds on previous findings about the role of inflammation in cardiometabolic dysfunction. By differentiating responders from non-responders, the study aims to support targeted therapeutic strategies for inflammation and cardiometabolic health.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Obese gastric bypass patients | – | Procedure: Gastric bypass |
| Lean healthy controls | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy controls and obese patients, scheduled to undergo bariatric surgery without a pre-surgical diet
Key inclusion criteria (3 listed)
- Individuals willing and able to give appropriate oral and written informed consent
- Men and women over 18 years of age.
- Correct body mass index (BMI) (Lean controls: 18.5-24.9 kg/m2. Obese gastric bypass patients: 35-50 kg/m2)
Key exclusion criteria (11 listed)
- The individual does not follow instructions given in the research study.
- Pregnancy.
- Significant gastrointestinal problems.
- Use of tobacco.
- The individual consumed alcohol within two days prior to the study visit
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 |
|---|---|---|
| Gastric bypassRoux-en-Y gastric bypass or sleeve gastrectomy | Procedure or surgery | Obese gastric bypass patients |
Primary outcome
Whole blood ROS prooduction
Time frame: At baseline and 1 year post surgery
The primary endpoint of the study is the therapeutic agent-induced reduction in reactive oxygen species (ROS) production in whole blood, following stimulation with N-Formylmethionyl-leucyl-phenylalanine (fMLP), escherichia coli (E. coli), and phorbol myristate acetate (PMA).
Whole blood ROS production
Time frame: At the time of enrollment
The primary endpoint of the study is the therapeutic agent-induced reduction in ROS production in whole blood, following stimulation with fMPL, E. coli, or PMA
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2025.
- Individual participant dataSharing planned: Undecided
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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.
Emma Börgeson, Dr., PhD, MSc principal investigator
University of Aarhus
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 Inflammation and Obesity and Type 2 Diabetes, run by University of Aarhus at 1 site in Denmark.
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 3 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 3 Feb 2025. 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 Denmark. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emma Börgeson, MSc (+45 9352 2984, emma.borgeson@biomed.au.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Whole blood ROS prooduction (time frame: At baseline and 1 year post surgery). 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 3 Feb 2025.