Atheroma Progression and Vulnerability Under Continuous Glucose Monitoring
OPTIMAL
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
1 other identifier
interventional
90
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Mar 2019
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2019
CompletedFirst Submitted
Initial submission to the registry
September 2, 2020
CompletedFirst Posted
Study publicly available on registry
September 22, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2022
CompletedSeptember 22, 2020
September 1, 2020
2.8 years
September 2, 2020
September 19, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
the normalized absolute change in total atheroma volume on serial intravascular ultrasound imaging.
This measure is analyzed by serial intravascular ultrasound imaging.
from baseline to 12 months
Secondary Outcomes (6)
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
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
- +1 more secondary outcomes
Study Arms (2)
HbA1c-guided group
NO INTERVENTIONGlycemic control is controlled by guideline-recommended HbA1c control.
CGM-guided group
ACTIVE COMPARATORGlycemic control is controlled by CGM-guided control.
Interventions
CGM (FreeStyle Libre Pro®, Abbott, Chicago, Illinoi, the United States)
Eligibility Criteria
You may qualify if:
- 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%)
- ≤ 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Cerebral & Cardiovascular Center
Suita, 5648565, Japan
Related Publications (1)
Kataoka Y, Hosoda K, Makino H, Matsubara M, Matsuo M, Ohata Y, Koezuka R, Tamanaha T, Tomita T, Honda-Kohmo K, Noguchi M, Son C, Nishimura K, Asaumi Y, Miyamoto Y, Noguchi T, Yasuda S. 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 (OPTIMAL). Cardiovasc Diagn Ther. 2019 Oct;9(5):431-438. doi: 10.21037/cdt.2019.09.02.
PMID: 31737515RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yu Kataoka, MD
National Cerebral & Cardiovascular Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chief consultant
Study Record Dates
First Submitted
September 2, 2020
First Posted
September 22, 2020
Study Start
March 1, 2019
Primary Completion
December 31, 2021
Study Completion
March 31, 2022
Last Updated
September 22, 2020
Record last verified: 2020-09