Coronary Atherosclerosis in Type 1 Diabetes Mellitus

Coronary Atherosclerosis in Type 1 Diabetes Mellitus - COALA

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON56585

Enrollment

Registered

2023-10-05

Start date

2023-10-01

Completion date

Unknown

Last updated

2024-04-09

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

Conditions

atheroma Atherosclerosis

Interventions

None listed

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: - Adult patients aged between 25 and 55 years old - Received diagnosis of T1DM > 5 years ago - > 2 years of available CGM data

Exclusion criteria

Exclusion criteria: - Renal insufficiency, defined as eGFR

Design outcomes

Primary

Measure	Time frame
The main parameter to study will be total coronary plaque volume.	—

Secondary

Measure	Time frame
- Calcified plaque volume - Non-calcified plaque volume - Low-density non-calcified plaque volume - Number and presence of high-risk plaque features, i.e.: • Positive remodeling (RI>1.1) • Low attenuation plaque (	—

Countries

Netherlands

Outcome results