Ignite Creation Date:
2025-12-25 @ 5:03 AM
Ignite Modification Date:
2025-12-26 @ 4:06 AM
Study NCT ID:
NCT06752018
Status:
RECRUITING
Last Update Posted:
2025-02-03
First Post:
2024-12-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Inflammation's Impact on Heart Disease and Diabetes
Sponsor:
University of Aarhus
Organization:
Study Overview
Official Title:
Inflammation: a Key Contributor to Heart Disease and Diabetes?
Status:
RECRUITING
Status Verified Date:
2024-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
INFO
Brief 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.
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.
Detailed Description:
The goal of this observational study is to investigate the relationship between treatment responsiveness and inflammation both systemically in blood, and peripherally in tissue biopsies, focusing on its relevance to cardiometabolic disease and associated conditions. The study aims to develop a predictive model to identify individuals most likely to benefit from anti-inflammatory treatments, thus supporting personalized therapeutic strategies.
Main research questions:
1. To investigate if the therapeutic agents modulate the inflammatory response linked to obesity and cardiometabolic disease
2. To determine the underlying factors that contribute to variations in individual responses to anti-inflammatory drugs
Study design:
The study will involve two participant groups:
* Healthy control group, composedrised of normal weight individuals
* Obese adult patients, scheduled to undergo bariatric surgery.
Participant procedures:
* Baseline testing: An initial test will evaluate treatment responsiveness.
* Tissue sampling: Tissue biopsies are obtained during surgery and undergo detailed analyses, including ex vivo treatments
* Follow-up assessments: Participants will be reassessed a year after surgery to evaluate long-term outcomes.
Methods:
* Molecular studies: Whole blood and peripheral tissue biopsies (adipose tissue, liver, muscle and intestinal biopsies) will be analyzed to identify cellular and molecular pathways associated with treatment responsiveness.
* Predictive modeling: Clinical, molecular, and biochemical data will be integrated to create a model predicting individual responsiveness.
* Insulin sensitivity analysis: Advanced imaging techniques will measure tissue-specific glucose uptake.
Hypotheses: Impaired ability to regulate the inflammatory response correlates with cardiometabolic disease.
Anticipated Outcomes:
The study seeks to support precision medicine approaches for addressing cardiometabolic disease.
This research builds on previous findings about the role of inflammation in cardiometabolic dysfunction. By differentiating responders from non-responders, the study aims to support targeted therapeutic strategies for inflammation and cardiometabolic health.
Main research questions:
1. To investigate if the therapeutic agents modulate the inflammatory response linked to obesity and cardiometabolic disease
2. To determine the underlying factors that contribute to variations in individual responses to anti-inflammatory drugs
Study design:
The study will involve two participant groups:
* Healthy control group, composedrised of normal weight individuals
* Obese adult patients, scheduled to undergo bariatric surgery.
Participant procedures:
* Baseline testing: An initial test will evaluate treatment responsiveness.
* Tissue sampling: Tissue biopsies are obtained during surgery and undergo detailed analyses, including ex vivo treatments
* Follow-up assessments: Participants will be reassessed a year after surgery to evaluate long-term outcomes.
Methods:
* Molecular studies: Whole blood and peripheral tissue biopsies (adipose tissue, liver, muscle and intestinal biopsies) will be analyzed to identify cellular and molecular pathways associated with treatment responsiveness.
* Predictive modeling: Clinical, molecular, and biochemical data will be integrated to create a model predicting individual responsiveness.
* Insulin sensitivity analysis: Advanced imaging techniques will measure tissue-specific glucose uptake.
Hypotheses: Impaired ability to regulate the inflammatory response correlates with cardiometabolic disease.
Anticipated Outcomes:
The study seeks to support precision medicine approaches for addressing cardiometabolic disease.
This research builds on previous findings about the role of inflammation in cardiometabolic dysfunction. By differentiating responders from non-responders, the study aims to support targeted therapeutic strategies for inflammation and cardiometabolic health.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: