Actively Recruiting
Inflammation's Impact on Heart Disease and Diabetes
Led by University of Aarhus · Updated on 2025-02-03
250
Participants Needed
1
Research Sites
304 weeks
Total Duration
On this page
AI-Summary
What this Trial 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.
CONDITIONS
Official Title
Inflammation's Impact on Heart Disease and Diabetes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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): 18.5-24.9 kg/m2 for lean controls, 35-50 kg/m2 for obese gastric bypass patients
You will not qualify if you...
- Individuals not following instructions given in the research study
- Pregnancy
- Significant gastrointestinal problems
- Use of tobacco
- Consumption of alcohol within two days prior to the study visit
- Active cancer within 5 years
- Use of dietary supplements affecting inflammatory resolution (e.g., fish oils) without willingness to discontinue 1 week before visits
- Underlying cardiometabolic disease or related medication
- Underlying inflammatory disease or related medication
- Increased bleeding tendency or use of blood-thinning medication
- For obese patients: weight loss greater than 8% since referral or greater than 3% in the 4 months before surgery
AI-Screening
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Trial Site Locations
Total: 1 location
1
Steno Diabetes Center Aarhus
Aarhus, Denmark, 8200
Actively Recruiting
Research Team
E
Emma Börgeson, MSc
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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