Fat Around Heart Arteries as a Measure of Inflammation in Patients With Glycometabolic Disease
NCT ID: NCT07144670
Last Updated: 2025-08-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
747 participants
OBSERVATIONAL
2016-03-31
2027-03-01
Brief Summary
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This study aims to answer the following questions:
• Is inflammation in the surrounding fat tissue of the heart arteries associated with the following glycometabolic conditions: I) Obesity ii) Prediabetes iii) Type 2 diabetes
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Detailed Description
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Inflammation in the coronary arteries is a key driver of cardiovascular (CV) disease, particularly in individuals with glycometabolic conditions such as obesity and diabetes. However, traditional biomarkers have limited accuracy in detecting coronary inflammation.
Coronary CT angiography (CCTA) allows for the non-invasive measurement of pericoronary adipose tissue (PCAT) attenuation - the fat surrounding coronary arteries. PCAT and the underlying vessels engage in bidirectional communication, and inflammation alters the structure of PCAT, which can be detected by CCTA.
Glycometabolic diseases promote atherosclerosis through endothelial dysfunction and accumulation of inflammatory cells. Obesity and diabetes are both associated with enlarged adipocytes, which may influence PCAT attenuation by lowering its Hounsfield Unit values, potentially masking underlying inflammation. To date, no studies have thoroughly addressed the possibility that PCAT attenuation may be underestimated in this high-risk CV population.
The PCAT-GMD study is a post-hoc analysis of two trials - CARPE-DM (NCT03016910) and DANCAP (NCT04525508) - aiming to evaluate the relationship between PCAT attenuation and the following glycometabolic conditions:
* Obesity (BMI)
* Prediabetes (HbA1c)
* Type 2 diabetes mellitus
Setting and study population:
A single-center cross-sectional, observational study at Odense University Hospital, Svendborg, Denmark. The study enrollment began in March 2016 and ended in July 2019. The study population included 747 cardiovascularly asymptomatic men with and without diabetes.
Examinations:
All participants underwent CCTA.
Additional assessments included:
* Blood pressure and heart rate
* Anthropometrics: height, weight, waist-to-hip ratio
* Blood and urine sampling
* Medical history
Conditions
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Study Design
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COHORT
CROSS_SECTIONAL
Study Groups
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Obesity (BMI)
Categorical: Normal (25-30), overweight (\>25-30), obesity 1 (\>30-35), obesity 2+ (\>35)
No interventions assigned to this group
Prediabetes
Categorical: Normal (\<39), Prediabtes (39-47 mmol/mol)
No interventions assigned to this group
Type 2 Diabetes Mellitus
Categorical: Without diabetes, with diabetes
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Capable of giving written informed consent
Exclusion Criteria
* Symtoms of CAD (angina)
* Any tachyarrhythmias making CCTA impossible
* Estimated glomerular filtration rate (eGFR) under 45 ml/min
* Allergy to iodine contrast
* Critical illness with life expectancy less than 1 year
* Documented heart failure
18 Years
MALE
No
Sponsors
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Odense University Hospital
OTHER
Responsible Party
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Katrine Schultz Overgaard
Dr. Med.
Principal Investigators
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Kenneth Egstrup, Professor
Role: PRINCIPAL_INVESTIGATOR
Cardiovascular Research Unit, OUH Svendborg Hospital.
Locations
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Cardiovascular Research Unit
Svendborg, , Denmark
Countries
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Other Identifiers
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PCAT-GMD
Identifier Type: -
Identifier Source: org_study_id
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