Coronary Atherosclerosis in Type 1 Diabetes Mellitus

In type 1 diabetes mellitus (T1DM) patients, coronary heart disease (CHD) is a
leading cause of morbidity and mortality. However, coronary plaque burden in
younger T1DM patients remains inadequately explored and rationale regarding the
optimal age to initiate lipid-lowering therapy (LLT) in T1DM is lacking.
Furthermore, the impact of time spent above euglycemic range (TAR) is an
emerging marker of poor glycemic control, while its impact as a risk factor for
cardiovascular risk in T1DM remains to be established.

The primary objective of this study is to evaluate the coronary plaque burden
and plaque characteristics in young T1DM patients as compared with non-diabetic
healthy controls, using coronary computed tomography angiography (CCTA). The
secondary objective is to assess the association between chronic and
intermittent hyperglycemia, as measured through glycated hemoglobin and TAR
respectively, and captured by continuous glucose monitoring (CGM), on coronary
plaque burden and plaque characteristics in T1DM patients.

Single center, observational, matched-pairs study.

The results of this study contribute to the discussion surrounding the optimal
age to initiate lipid-lowering therapy (LLT) in T1DM. Moreover, the results
will enhance our understanding of the impact of excessive hyperglycemia on
coronary plaque burden and plaque characteristics in patients diagnosed with
T1DM prior to clinically established CVD.

Participating T1DM patients in this study may benefit from increased awareness
of their potentially elevated plaque burden, which can lead to the
implementation of optimal risk-reducing medications (such as statins) and
lifestyle interventions. Additionally, the utilization of CCTA imaging may
provide incidental benefits by enabling early detection and treatment of
extra-cardiac findings, including pulmonary malignancies. Decisions regarding
the management of cardiac findings, such as significant coronary lesions, will
be left to the discretion of the treating physician. Furthermore, the expected
risk for participants is low. The most important risk in this study is
radiation exposure. However, the maximum exposure related to CCTA imaging is
1.4 mSv. This is a low radiation exposure and even lower than the yearly dose
of background radiation in the Netherlands. Furthermore, ionized contrast
agents will be used during CCTA, which can be nephrotoxic and may elicit
allergic reactions. However, in the GUTDM1 the prevalence of pre-existing eGFR
<60ml/min is exceedingly rare, leading to a very low risk of nephrotoxicity.
The control group has previously undergone CCTA as part of a recent study
conducted at Amsterdam UMC. Consequently, no additional interventions will be
administered to this group.
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