Atheroma Progression and Vulnerability Under Continuous Glucose Monitoring (OPTIMAL)

September 19, 2020 updated by: Yu Kataoka, National Cerebral and Cardiovascular Center

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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..

With regard to the use of anti-diabetic drugs, in the CGM-guided glycemic control group, endocrinologist will select glucose lowering drugs to fulfill the following CGM-derived goals: (a) the frequency of hypoglycemia=0%, (b) the coefficient of variation <36% and (c) averaged glucose level between 70-180 mg/dl.6 If the frequency of hypoglycemia is over 10% and/or the averaged glucose level is more than 400 mg/dl, patients will be asked to visit within 1 month after CGM measurement. In the HbA1c-guided therapy group, the selection of glucose lowering agents will be made according to the discretion of each endocrinologist to achieve HbA1c <7.0%.

At 12 months following PCI, patients will be hospitalized to take follow-up coronary angiography and intravascular imaging study. NIRS/IVUS imaging in the non-culprit vessel will be conducted again in a similar fashion.

Study Type

Interventional

Enrollment (Anticipated)

90

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Japan
      • Suita, Japan, 5648565
        • Recruiting
        • National Cerebral & Cardiovascular Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: HbA1c-guided group
Glycemic control is controlled by guideline-recommended HbA1c control.
Active Comparator: CGM-guided group
Glycemic control is controlled by CGM-guided control.
Device: continuous glucose monitoring (CGM)
CGM (FreeStyle Libre Pro®, Abbott, Chicago, Illinoi, the United States)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the normalized absolute change in total atheroma volume on serial intravascular ultrasound imaging.
Time Frame: from baseline to 12 months
This measure is analyzed by serial intravascular ultrasound imaging.
from baseline to 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the absolute change in percent atheroma volume on serial intravascular ultrasound imaging.
Time Frame: from baseline to 12 months
This measure is analyzed by serial intravascular ultrasound imaging.
from baseline to 12 months
the percent change in lipid core burden index on serial near-infrared spectroscopy imaging.
Time Frame: from baseline to 12 months
This measure is analyzed by serial near-infrared spectroscopy imaging.
from baseline to 12 months
the change in coefficient variance evaluated by CGM
Time Frame: from baseline to 12 months
This measure is analyzed 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
Time Frame: from baseline to 12 months
The correlation of IVUS measure with concentration of serum proprotein convertase subxilisin/kexin type 9 is analyzed.
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)
Time Frame: from baseline to 12 months
This measure is analyzed by serial intravascular ultrasound imaging.
from baseline to 12 months
the frequency of hypoglycemia
Time Frame: from baseline to 12 months
This event is collected through each clinical visit.
from baseline to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cerebral and Cardiovascular Center

Investigators

  • Principal Investigator: Yu Kataoka, MD, National Cerebral & Cardiovascular Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2019

Primary Completion (Anticipated)

December 31, 2021

Study Completion (Anticipated)

March 31, 2022

Study Registration Dates

First Submitted

September 2, 2020

First Submitted That Met QC Criteria

September 19, 2020

First Posted (Actual)

September 22, 2020

Study Record Updates

Last Update Posted (Actual)

September 22, 2020

Last Update Submitted That Met QC Criteria

September 19, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M30-152-2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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