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NCT Number: NCT07144670

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

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Obesity &Amp; Overweight Adipose Tissue Adipose Tissue Inflammation Body Weight Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Inflammation Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity Type 2 Diabetes Mellitus Overnutrition Overweight Pathologic Processes Pathological Conditions, Signs and Symptoms PreDiabetes Prediabetic State Signs and Symptoms Type 2 Diabetes (T2DM)

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Cardiovascular Research Unit

Svendborg, 5700, Denmark

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. PCAT Attenuation [Hounsfield Units (HU)] measured by coronary CT angiography

    Time frame: Baseline

    PCAT 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 outcomes

  1. PCAT Attenuation [HU] measured by coronary CT angiography

    Time frame: Baseline

    Analyses 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.

Sponsors and collaborators

Lead sponsor

Odense University Hospital

Other

Registry information

Official study title

Evaluating Pericoronary Adipose Tissue Attenuation in Glycometabolic Diseases

Acronym: PCAT-GMD

Important dates

Study start
2016
Primary completion
2019
Study completion
2027
First posted
Aug 27, 2025
Registry last updated
Aug 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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