Inflammation's Impact on Heart Disease and Diabetes
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Aarhus
About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
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)
Disqualifiers
The individual does not follow instructions given in the research study.
Pregnancy.
Significant gastrointestinal problems.
Use of tobacco.
Trial population
Healthy controls and obese patients, scheduled to undergo bariatric surgery without a pre-surgical diet
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Gastric bypass
Procedure/SurgeryRoux-en-Y gastric bypass or sleeve gastrectomy
Treatment groups
250 Participants
are divided into 2 treatment groupsGroup A: Obese gastric bypass patients1 intervention
Group B: Lean healthy controls0 interventions
Trial outcomes
Primary outcomes
1
Whole blood ROS prooduction
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).
Time frame
At baseline and 1 year post surgery2
Whole blood ROS production
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
Time frame
At the time of enrollmentSponsors and contacts
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Source ClinicalTrials.gov