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Fat Around Heart Arteries as a Measure of Inflammation in Patients With Glycometabolic Disease

Evaluating Pericoronary Adipose Tissue Attenuation in Glycometabolic Diseases

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07144670
Acronym
PCAT-GMD
Enrollment
747
Registered
2025-08-27
Start date
2016-03-31
Completion date
2027-03-01
Last updated
2025-08-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adipose Tissue, Adipose Tissue Inflammation, Inflammation, Obesity &Amp; Overweight, Obesity Type 2 Diabetes Mellitus, Prediabetes, Type 2 Diabetes (T2DM)

Keywords

inflammation, type 2 diabetes mellitus, diabetes, prediabetes, obesity, pericoronary adipose tissue, PCAT

Brief summary

In this study, the objective is to investigate inflammation in the arteries of the heart. A heart CT scan (CCTA) will be used to measure inflammation by assessing the fat tissue surrounding the arteries of the heart. Participants with and without type 2 diabetes who have no heart symptoms have been examined and had a CCTA scan performed. 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

Detailed description

Background and significance: 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

Interventions

None listed

Sponsors

Odense University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Above 18 years * Capable of giving written informed consent

Exclusion criteria

* History of CAD * 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

Design outcomes

Primary

MeasureTime frameDescription
PCAT Attenuation [Hounsfield Units (HU)] measured by coronary CT angiographyBaselinePCAT attenuation \[HU\] will be assessed for correlation with the following variables: * BMI \[kg/m²\] \[Continously, and categorized as normal (ref), overweight, obesity class 1, obesity class 2+\]. * Prediabetes, defined as HbA1c: 39-47 mmol/mol \[Categorical: no(ref)/yes\]. * Type 2 diabetes mellitus, defined by WHO criteria \[Categorical: no(ref)/yes\].

Secondary

MeasureTime frameDescription
PCAT Attenuation [HU] measured by coronary CT angiographyBaselineAnalyses will assess whether BMI (kg/m²) mediates the correlation between glycemic status (prediabetes \[HbA1c 39-47 mmol/mol, categorical: no/yes\] or type 2 diabetes mellitus \[WHO criteria\], categorical: no/yes\] and PCAT attenuation.

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026