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
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- the normalized absolute change in total atheroma volume on serial intravascular ultrasound imaging.
研究概览
简要总结
The OPTIMAL is a single-center, randomized trial to evaluate the efficacy of CGM-based glycemic control on atheroma progression in T2DM patients with CAD by using serial intravascular ultrasound (IVUS) and near-infrared spectroscopy (NIRS) imaging. A total of 90 eligible subjects will be randomized 1:1 into 2 groups to receive either CGM-based glycemic control or HbA1c-baded glycemic management. Coronary angiography and NIRS/IVUS imaging is repeated at the end of the assigned treatment period.
Results: The primary endpoint is the normalized absolute change in total atheroma volume from baseline to 12 months. The secondary endpoints include (1) the absolute change in percent atheroma volume, (2) the percent change in lipid core burden index, (3) the change in coefficient variance measured by CGM, (4) the change in atherogenic markers (high-density lipoprotein functionality, proprotein convertase subxilisin/kexin type 9 and fatty-acid binding proteins), and (5) the frequency of hypoglycemia. Safety will also be evaluated.
详细描述
Enrollment of 90 patients is planned at National Cerebral & Cardiovascular Center in Japan. Study participants are randomly assigned to either CGM-based glucose management or HbA1c-based glucose management.
Eligible subjects should have CAD requiring elective PCI. HbA1c at screening should be between 7.0 and 10.0%.
Non-culprit vessel with its severe tortuousty and/or calcification will be excluded. Subjects with baseline estimated glomerular filtration rate <40 mL/min/1.73m2 will not be eligible.
After informed consent has been obtained, elective PCI will be conducted to treat culprit lesion. NIRS/IVUS imaging will be conducted to evaluate coronary atheroma.
In the CGM-based glucose management group, CGM (FreeStyle Libre Pro®, Abbott, Chicago, Illinoi, the United States) and HbA1c measurement will be undertaken at baseline and 3, 6, 9 and 12 months following PCI. In the HbA1c-based glucose management group, HbA1c will be measured at baseline and 3, 6, 9 and 12 months after PCI, and CGM will be used at baseline and 12 months in a similar fashion..
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male of female between 20 and 85 years of age
- •Type 2 diabetic patients with coronary artery disease who require PCI
- •The presence of mild stenosis in the non-target vessel (% diameter stenosis between 10-50%)
- •7.0 ≤ HbA1c ≤ 10.0%
- •HbA1c ≤ 10.0% in subjects who receive insulin, sulfonylurea or nateglinide
- •Ability to understand the requirements of the study and to provide informed consent
排除标准
- •very tortuous coronary artery and/or severe calcification which is unsuitable for intravascular imaging
- •Subjects with severe renal dysfunction (estimated glomerular filtration rate < 40 mL/min/1.73m2)
- •the absence of any atherosclerotic lesions in the non-target vessel those who take PCSK9 inhibitor
- •current enrolment in another investing device or drug study pregnancy
结局指标
主要结局
the normalized absolute change in total atheroma volume on serial intravascular ultrasound imaging.
时间窗: from baseline to 12 months
This measure is analyzed by serial intravascular ultrasound imaging.
次要结局
- the change in coefficient variance evaluated by CGM(from baseline to 12 months)
- the correlation of change in concentration of serum proprotein convertase subxilisin/kexin type 9 with the normalized absolute change in total atheroma volume(from baseline to 12 months)
- change in TAV under the use of specific anti-diabetic agents (dipeptidyl peptidase-4 inhibitors, sodium-glucose transport protein 2 inhibitors and glucagon-like peptide-1 agonists)(from baseline to 12 months)
- the frequency of hypoglycemia(from baseline to 12 months)
- the absolute change in percent atheroma volume on serial intravascular ultrasound imaging.(from baseline to 12 months)
- the percent change in lipid core burden index on serial near-infrared spectroscopy imaging.(from baseline to 12 months)
研究者
Yu Kataoka
Chief consultant
National Cerebral and Cardiovascular Center, Japan