Investigating inflammation's role in heart disease and diabetes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.