RecruitingNCT06752018

Inflammation's Impact on Heart Disease and Diabetes

Inflammation: a Key Contributor to Heart Disease and Diabetes?


Sponsor

University of Aarhus

Enrollment

250 participants

Start Date

Jan 30, 2025

Study Type

OBSERVATIONAL

Conditions

Summary

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study examines how inflammation affects the development of heart disease and diabetes, specifically comparing lean healthy adults to people with obesity who are scheduled for gastric bypass (weight-loss) surgery. **You may be eligible if...** - You are over 18 years old - You are either lean (BMI 18.5–24.9) or obese (BMI 35–50) and scheduled for gastric bypass surgery - You are willing and able to give informed consent and follow study instructions **You may NOT be eligible if...** - You are pregnant - You use tobacco - You consumed alcohol within 2 days before the study visit - You have significant digestive problems - You have had an active cancer in the past 5 years - You have an underlying heart, metabolic, or inflammatory condition (or take medications for one) - You take fish oil or other anti-inflammatory supplements and are unwilling to stop them 1 week before visits - You are on blood-thinning medication Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREGastric bypass

Roux-en-Y gastric bypass or sleeve gastrectomy


Locations(1)

Steno Diabetes Center Aarhus

Aarhus, Denmark

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NCT06752018


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