NCT07144670

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

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
747

participants targeted

Target at P75+ for all trials

Timeline
10mo left

Started Mar 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress93%
Mar 2016Mar 2027

Study Start

First participant enrolled

March 1, 2016

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2019

Completed
6.1 years until next milestone

First Submitted

Initial submission to the registry

August 13, 2025

Completed
14 days until next milestone

First Posted

Study publicly available on registry

August 27, 2025

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2027

Expected
Last Updated

August 27, 2025

Status Verified

August 1, 2025

Enrollment Period

3.3 years

First QC Date

August 13, 2025

Last Update Submit

August 20, 2025

Conditions

Obesity &Amp; OverweightObesity Type 2 Diabetes MellitusType 2 Diabetes (T2DM)PrediabetesInflammationAdipose TissueAdipose Tissue Inflammation

Keywords

inflammationtype 2 diabetes mellitusdiabetesprediabetesobesitypericoronary adipose tissuePCAT

Outcome Measures

Primary Outcomes (1)

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

    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 \[Categorical: no(ref)/yes\].

    Baseline

Secondary Outcomes (1)

  • PCAT Attenuation [HU] measured by coronary CT angiography

    Baseline

Study Arms (3)

Obesity (BMI)

Categorical: Normal (25-30), overweight (\>25-30), obesity 1 (\>30-35), obesity 2+ (\>35)

Prediabetes

Categorical: Normal (\<39), Prediabtes (39-47 mmol/mol)

Type 2 Diabetes Mellitus

Categorical: Without diabetes, with diabetes

Eligibility Criteria

Age18 Years+
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsMen
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

CARPE-DM: Participants with type 2 diabetes who were cardiac asymptomatic and had no history of CAD. Participants were recruited from the Endocrinology Outpatient Clinic and the Retina Photographhy Clinic at Odense University Hospital, Svendborg, Denmark. DANCAP: Participants in the age range 65-75 years were recruitted from the large Danish Cardiovascular Screening (DANCAVAS) at Odense University Hospital (OUH), Svendborg Hospital, Denmark. Participants were cardiac asymptomatic and had no history of CAD.

You may qualify if:

  • Above 18 years
  • Capable of giving written informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cardiovascular Research Unit

Svendborg, 5700, Denmark

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Fasting blood samples included; HbA1c, low-density lipoprotein (LDL), high-density lipoprotein HDL, triglycerides (TG), creatinine, high-sensitivity C-reactive peptide (hs-CRP).

MeSH Terms

Conditions

ObesityOverweightDiabetes Mellitus, Type 2Prediabetic StateInflammationDiabetes Mellitus

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsGlucose Metabolism DisordersMetabolic DiseasesEndocrine System DiseasesPathologic Processes

Study Officials

  • Kenneth Egstrup, Professor

    Cardiovascular Research Unit, OUH Svendborg Hospital.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Med.

Study Record Dates

First Submitted

August 13, 2025

First Posted

August 27, 2025

Study Start

March 1, 2016

Primary Completion

July 1, 2019

Study Completion (Estimated)

March 1, 2027

Last Updated

August 27, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)