Actively Recruiting

Age: 18Years +
All Genders
Healthy Volunteers
NCT06752018

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

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

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
Not Eligible

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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Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Steno Diabetes Center Aarhus

Aarhus, Denmark, 8200

Actively Recruiting

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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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