Clinical trial
Inflammation's Impact on Heart Disease and Diabetes
Recruiting now · Not applicable · 1 countries · Registry ID NCT06752018
What this study is about
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.
Basic eligibility
Full registry criteria
Treatments and study arms
Gastric bypass
Roux-en-Y gastric bypass or sleeve gastrectomy
Primary outcomes
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).
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
Study locations
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