NCT06752018Recruiting
Inflammation's Impact on Heart Disease and Diabetes
Inflammation: a Key Contributor to Heart Disease and Diabetes?
Source: ClinicalTrials.gov · Last updated 3 Feb 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 250 (estimated)
- First submitted
- 20 Dec 2024
- Start date
- 30 Jan 2025
- Primary completion date
- 31 Dec 2030
- Lead sponsor
- University of Aarhus
- Diseases
- Obesity, Type 2 diabetes
- NCT number
- NCT06752018
What you commit to
- Study type: Observational
- Planned participants: 250
- From 30 Jan 2025 to the primary completion date, 31 Dec 2030
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- The individual consumed alcohol within two days prior to the study visit
- Use of dietary supplements that impact the inflammatory resolution process (e.g., fish oils), and the person is not willing to discontinue the use of the supplements 1 week prior to the visits.
- For obese patients only: The individual has lost more than 8% of his/her body weight since their clinical referral for surgery or has lost more than 3% of his/her body weight in the 4 months leading up to surgery.
Other illness
- Active cancer within 5 years.
- Underlying cardiometabolic disease, or medication related to such disease (e.g., blood pressure medication, insulin to treat diabetes, etc.).
- Underlying inflammatory disease, or medication related to such disease.
- The individual states that they have increased bleeding tendency or are using anti-coagulant (blood-thinning) medication.
Other
- The individual does not follow instructions given in the research study.
- Pregnancy.
- Significant gastrointestinal problems.
- Use of tobacco.
Who the study is looking for
- 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)
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| steno diabetes center Aarhus Coordinator of this site? Confirm its status | Aarhus | Denmark | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.