Investigating inflammation's role in heart disease and diabetes
Inflammation: a Key Contributor to Heart Disease and Diabetes?
This study is testing how inflammation affects heart disease and diabetes in people who are healthy compared to those who are severely obese, to see if it can help identify who might benefit from new treatments.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 250 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Aarhus Academic / other |
| Locations | 1 site (Aarhus) |
| Trial ID | NCT06752018 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the inflammatory response associated with cardiometabolic diseases, particularly focusing on obesity and type 2 diabetes. It involves two groups: healthy volunteers and severely obese patients undergoing weight-loss surgery. Participants will undergo baseline testing, provide tissue samples during surgery, and participate in follow-up assessments to track changes over time. The study seeks to develop a predictive model to identify individuals most likely to benefit from anti-inflammatory treatments, thereby supporting personalized therapeutic strategies.
Who should consider this trial
Good fit: Ideal candidates include men and women over 18 years old with a BMI of 35-50 kg/m2 who are scheduled for gastric bypass surgery, as well as healthy individuals with a BMI of 18.5-24.9 kg/m2.
Not a fit: Patients with active cancer, significant gastrointestinal problems, or underlying inflammatory diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to personalized treatments that effectively reduce inflammation and improve outcomes for patients with obesity and cardiometabolic diseases.
How similar studies have performed: Other studies have shown promise in understanding the relationship between inflammation and cardiometabolic diseases, but this specific approach is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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/m2. 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.
Where this trial is running
Aarhus
- Steno Diabetes Center Aarhus — Aarhus, Denmark (Recruiting)
Study contacts
- Principal investigator: Emma Börgeson, Dr., PhD, MSc — University of Aarhus
- Study coordinator: Emma Börgeson, MSc
- Email: emma.borgeson@biomed.au.dk
- Phone: +45 9352 2984
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.