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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
90

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National Cerebral and Cardiovascular Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2019

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2021

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 2, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 19, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 22, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 22, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 19, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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Conditions

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Drug Interventions

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