Inflammation's Impact on Heart Disease and Diabetes
Inflammation: a Key Contributor to Heart Disease and Diabetes?
University of Aarhus
250 participants
Jan 30, 2025
OBSERVATIONAL
Conditions
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: 1. To investigate if the therapeutic agents modulate the inflammatory response linked to obesity and cardiometabolic disease? 2. 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.
Eligibility
Inclusion Criteria3
- 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)
Exclusion Criteria11
- 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.
Interventions
Roux-en-Y gastric bypass or sleeve gastrectomy
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06752018