Coronary Atheroma Progression under Glucose Control with ConTInuous Glucose Monitoring

JRCT ID: jRCT1052180152

Registered date:25/03/2019

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Coronary artery disease in patients with type 2 diabetes mellitus
• Date of first enrollment: 06/03/2019
• Target sample size: 90
• Study type: Interventional

Intervention(s)

A. glycemic management under CGM use
B. glycemic management under HbA1c measurement

Outcome(s)

• Primary Outcome: Absolute change in plaque volume

Secondary Outcome

Absolute change in percent atheroma volume
Absolute change in lipid core burden index
the frequency of hypoglycemia

Key inclusion & exclusion criteria

• Age minimum: 20age
• Age maximum: 80age
• Gender: Both

Include criteria

1. Male of female between 20 and 80 years of age
2. Type 2 diabetic patients with coronary artery disease
3. Subjects requiring PCI
4. The presence of mild stenosis in the non-target vessel (percent diameter
stenosis between 10-50%) identified by coronary angiography within 12 weeks prior to PCI
5. HbA1c betweeen 7.0% and 10.0%
6. HbA1c less than 10.0% in subjects who receive insulin, sulfonylurea or
nateglinide
7. Ability to understand the requirements of the study and to provide
informed consent

Exclude criteria

1. very tortuous coronary artery and/or severe calcification which is unsuitable for
intravascular imaging
2. Subjects with severe renal dysfunction (estimated glomerular filtration rate < 40 mL/min/1.73m2)
3. the absence of any atherosclerotic lesions in the non-target vessel
4. those who take PCSK9 inhibitor
5. Pregnancy
6. Current enrolment in another investing device or drug study
7. unsuitable subject according to the investigator's discretion

Related Information

• Primary Sponsor: Kataoka Yu
• Source(s) of Monetary Support: Japan Agency for Medical Research and Development
• Secondary ID(s): Nil known