Inflammation: a Key Contributor to Heart Disease and Diabetes?
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- University of Aarhus
- Enrollment
- 250
- Locations
- 1
- Primary Endpoint
- Whole blood ROS prooduction
Study Overview
Brief 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. 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:
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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/m
- •Obese gastric bypass patients: 35-50 kg/m2)
Exclusion Criteria
- •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.
- •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.
Outcomes
Primary Outcomes
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
Secondary Outcomes
No secondary outcomes reported