Clinical trials / NCT06752018
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Inflammation's Impact on 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: 1. To investigate if the therapeutic agents modulate the inflammatory response linked to obesity and cardiometabolic disease? 2. What underlying…

ClinicalTrials.gov IDNCT06752018
PhaseNot Applicable
Enrollment250
SponsorUniversity of Aarhus
Age18 Years
SexALL
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Conditions studied

Inflammation, Obesity and Type 2 Diabetes, Obesity, Metabolic Syndrome, Anti-Inflammatory Agents

About this study

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.

Interventions

Primary outcomes

Eligibility information

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.

Study locations

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.