Actively Recruiting
Inflammation: a Key Contributor to Heart Disease and Diabetes?
Led by University of Aarhus · Updated on 2025-02-03
250
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to understand how inflammation is linked to heart disease, diabetes, and related metabolic conditions, focusing on both healthy individuals and severely obese patients scheduled for weight-loss surgery. It seeks to find out if certain treatments can change the inflammatory response related to obesity and cardiometabolic diseases and what factors influence individual differences in treatment responses. The study is observational and aims to support personalized treatment approaches by identifying who may benefit most from anti-inflammatory therapies. The study includes two groups: healthy adults with normal weight and obese adults undergoing bariatric surgery such as Roux-en-Y gastric bypass or sleeve gastrectomy. Participants will have baseline tests to assess their inflammatory response, tissue biopsies taken during surgery for detailed analysis including treatment exposure outside the body, and follow-up visits about one year after surgery to monitor long-term changes. Advanced molecular and imaging methods will be used to study blood and tissue samples, including fat, liver, muscle, and intestinal tissues. Participants will be involved through initial testing, providing tissue samples during surgery, and follow-up assessments a year later to track changes in inflammation and metabolism. Researchers will measure outcomes such as reactive oxygen species production in whole blood at enrollment and one year post-surgery. Data from clinical, molecular, and biochemical tests will be combined to predict how individuals respond to therapy. The study is designed to improve understanding of inflammation's role in cardiometabolic disease and to help develop more targeted treatments.
CONDITIONS
Brief 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): Lean controls 18.5-24.9 kg/m2, Obese gastric bypass patients 35-50 kg/m2
You will not qualify if you...
- Individuals who do not follow instructions given in the research study
- Pregnancy
- Significant gastrointestinal problems
- Use of tobacco
- Alcohol consumption 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 prior to 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 of more than 8% since referral or more than 3% in the 4 months before surgery
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo initial tests to evaluate treatment responsiveness, including blood sample collection and clinical assessments.
1 baseline visit (in-person)
Duration - Surgery day plus immediate recovery
Obese participants undergo bariatric surgery (Roux-en-Y gastric bypass or sleeve gastrectomy) during which tissue biopsies are collected for molecular analyses.
1 surgery visit (in-person)
Duration - 1 day, one year post surgery
Participants are reassessed one year after surgery to evaluate long-term outcomes, including blood tests and imaging for insulin sensitivity.
1 follow-up visit (in-person)
Trial Site Locations
Total: 1 location
1
Steno Diabetes Center Aarhus
Aarhus, Denmark, 8200
Actively Recruiting
Research Team
E
Emma Börgeson, MSc
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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