Observation of Coronary Atheroma Progression under Glucose Control with ConTInuous Glucose Monitoring GuidAnce in Patients with Type 2 Diabetes MeLlitus: Near-infrared Spectroscopic Analaysis

Conditions

Coronary artery disease requiring percutaneous coronary intervention

Salib A, Kataoka Y, Nicholls SJ, Kitahara S, Funabashi S, Makino H, Matsubara M, Matsuo M, Omura-Ohata Y, Koezuka R, Tochiya M, Tamanaha T, Tomita T, Honda-Kohmo K, Noguchi M, Mitsui K, Murai K, Iwai T, Sawada K, Matama H, Honda S, Fujino M, Yoneda S, Nakao K, Takagi K, Otsuka F, Asaumi Y, Hosoda K, Yasuda S, Noguchi T.

2025-12-15

10.1016/j.jacl.2025.12.011

Apolipoprotein CIII in statin-treated type 2 diabetic patients: Its implications for plaque progression and instability: The pre-specified analysis from the OPTIMAL randomized controlled trial.

Kitahara S, Kataoka Y, Nicholls SJ, Funabashi S, Nakatsuka K, Nishimura K, Makino H, Matsubara M, Matsuo M, Omura-Ohata Y, Koezuka R, Tochiya M, Tamanaha T, Tomita T, Honda-Kohmo K, Noguchi M, Murai K, Iwai T, Sawada K, Matama H, Honda S, Fujino M, Yoneda S, Takagi K, Otsuka F, Asaumi Y, Hosoda K, Yasuda S, Noguchi T.

2025-08-07

10.1016/j.atherosclerosis.2025.120470

Circulating apolipoprotein B levels in statin-treated type 2 diabetic patients with coronary artery disease: Implications for coronary atheroma progression and instability.

Funabashi S, Kataoka Y, Nicholls SJ, Kitahara S, Makino H, Matsubara M, Matsuo M, Omura-Ohata Y, Koezuka R, Tochiya M, Tamanaha T, Tomita T, Honda-Kohmo K, Noguchi M, Murai K, Sawada K, Iwai T, Matama H, Honda S, Fujino M, Nakao K, Yoneda S, Takagi K, Otsuka F, Asaumi Y, Hosoda K, Yasuda S, Noguchi T.

2025-05-071 citations

10.1016/j.jacl.2025.04.204

Glucagon-like Peptide-1 analogues and delipidation of coronary atheroma in statin-treated type 2 diabetic patients with coronary artery disease: The prespecified sub-analysis of the OPTIMAL randomized clinical trial.

Kataoka Y, Kitahara S, Funabashi S, Makino H, Matsubara M, Matsuo M, Omura-Ohata Y, Koezuka R, Tochiya M, Tamanaha T, Tomita T, Honda-Kohmo K, Noguchi M, Murai K, Sawada K, Iwai T, Matama H, Honda S, Fujino M, Nakao K, Yoneda S, Takagi K, Otsuka F, Asaumi Y, Hosoda K, Nicholls SJ, Yasuda S, Noguchi T.

2024-04-044 citations

10.1016/j.athplu.2024.03.001

The efficacy of glycemic control with continuous glucose monitoring on atheroma progression: rationale and design of the Observation of Coronary Atheroma Progression under Continuous Glucose Monitoring Guidance in Patients with Type 2 Diabetes Mellitus (OPTIMAL).

Kataoka Y, Hosoda K, Makino H, Matsubara M, Matsuo M, Ohata Y, Koezuka R, Tamanaha T, Tomita T, Honda-Kohmo K, Noguchi M, Son C, Nishimura K, Asaumi Y, Miyamoto Y, Noguchi T, Yasuda S.

2019-10-015 citations

10.21037/cdt.2019.09.02

Interventions

CGM-guided glycemic control HbA1c-guided glycemic control

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Eligible subjects should have CAD requiring elective PCI. Mild stenosis needs to exist within non-culprit major coronary artery. Since the current study enroll subjects who need glucose lowering therapy to achieve HbA1c (NGSP/IFCC) < 7.0%/53 mmol/mol, HbA1c (NGSP/IFCC) at screening should be between 7.0/53 and 10.0%/86 mmol/mol. In T2DM subjects who already receive sulphonylurea, nateglinide and/or insulin at screening, baseline HbA1c (NGSP/IFCC) should be below 10.0%/86 mmol/mol and the lowest cut-off is not set. Due to an elevated risk of hypoglycemia under these anti-diabetic agents, subjects with HbA1c (NGSP/IFCC) <7.0%/53 mmol/mol may have hypoglycemic events which require adequate glycemic control.

Exclusion criteria

Exclusion criteria: The main exclusion criteria are listed in Table 3. Non-culprit vessel with its severe tortuousty and/or calcification will be excluded due to the risk of NIRS/IVUS imaging. Subjects with baseline estimated glomerular filtration rate <40 mL/min/1.73m2, those without any atherosclerotic lesions in their non-culprit vessels and patients who are taking or are scheduled to receive proprotein convertase subxilisin/kexin type 9 will not be eligible.

Design outcomes

Primary

Measure	Time frame
the absolute change in percent atheroma volume	—

Secondary

Measure	Time frame
change in percent atheroma volume the percent change in lipid core burden index the frequency of hypoglycemia	—

Countries

Japan

Contacts

Public ContactYu Kataoka

National Cerebral & Cardiovascular Center Department of Cardiovascular Medicine

yu.kataoka@ncvc.go.jp06-6833-5012

Outcome results

None listed