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Atheroma Progression and Vulnerability Under Continuous Glucose Monitoring

NCT04559191 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2020-09-22

No results posted yet for this study

Summary

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.

Conditions

  • Coronary Atherosclerosis

Interventions

DEVICE

continuous glucose monitoring (CGM)

CGM (FreeStyle Libre Pro®, Abbott, Chicago, Illinoi, the United States)

Sponsors & Collaborators

  • National Cerebral and Cardiovascular Center, Japan

    lead OTHER

Principal Investigators

  • Yu Kataoka, MD · National Cerebral & Cardiovascular Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-01
Primary Completion
2021-12-31
Completion
2022-03-31
FDA Device
Yes

Countries

  • Japan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04559191 on ClinicalTrials.gov