UMIN-CTR Clinical Trial

Public title

Establishment of screening system for identifying ng high-risk individuals for developing diabetic macroangiopathy using carotid ultrasound

Acronym

Establishment of diabetic macroangiopathy screening system using carotid ultrasound

Scientific Title

Establishment of screening system for identifying ng high-risk individuals for developing diabetic macroangiopathy using carotid ultrasound

Scientific Title:Acronym

Establishment of diabetic macroangiopathy screening system using carotid ultrasound

Region

Japan

Condition

diabetes

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

The aim of this study is as follows:
(1) To evaluate whether carotid ultrasound can add prognostic information beyond conventional cardiovascular risk markers in patients with diabetes.
(2) To determine the cut-off value of carotid IMT to identify high-risk individuals for developing cardiovascular events.
(3) To determine the optimal inspection interval.
(4) To evaluate whether the progression of carotid IMT can be used as a surrogate endpoint of cardiovascular events.

Basic objectives2

Others

Basic objectives -Others

Usefulness of the clinical test

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Whether carotid ultrasound can add prognostic information beyond conventional cardiovascular risk markers in patients with diabetes.

Key secondary outcomes

Study type

Others,meta-analysis etc

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

Purpose of intervention

Type of intervention

Interventions/Control_1

Interventions/Control_2

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

Not applicable

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

N/A
(Recruitment of new subjects for this study is not considered. The present study was an integration analysis and based on the fixed data obtained from 3 prospective observational studies and 2 clinical trials in Japanese diabetic patients, where carotid IMT was measured at baseline and the occurrence of a cardiovascular event during the follow-up period was recorded.)

Key exclusion criteria

N/A

Target sample size

3707

Name of lead principal investigator

1st name
Middle name
Last name	Naoto Katakami

Organization

Osaka University Graduate School of Medicine

Division name

Department of Metabolic Medicine

Zip code

Address

2-2, Yamadaoka, Suita, Osaka

TEL

06-6879-3743

Email

katakami@endmet.med.osaka-u.ac.jp

Name of contact person

1st name
Middle name
Last name	Naoto Katakami

Organization

Osaka University Graduate School of Medicine

Division name

Department of Metabolic Medicine

Zip code

Address

2-2, Yamadaoka, Suita, Osaka

TEL

06-6879-3743

Homepage URL

Email

katakami@endmet.med.osaka-u.ac.jp

Institute

Osaka University Graduate School of Medicine, Department of Metabolic Medicine

Institute

Department

Personal name

Organization

Non

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2015

Year

12

Month

07

Day

URL releasing protocol

Publication of results

Published

URL related to results and publications

Number of participants that the trial has enrolled

Results

Based on a combined analysis of data obtained in five longitudinal studies including a total of 3263 patients with diabetes, we found addition of carotid ultrasonography measures to conventional risk factors significantly improved stratification of patients by cardiovascular risk. Notably, increment of carotid IMT and GSM during the observation period were also prognostic factors for CVD even after adjusting for the baseline value of the respective measure.

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

Date of protocol fixation

2015

Year

12

Month

07

Day

Date of IRB

Anticipated trial start date

2016

Year

02

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

2017

Year

12

Month

31

Day

Other related information

The present study was an integration analysis and based on the fixed data obtained from 3 prospective observational studies and 2 clinical trials in Japanese diabetic patients, where carotid IMT was measured at baseline and the occurrence of a cardiovascular event during the follow-up period was recorded.

Registered date

2015

Year

12

Month

07

Day

Last modified on

2018

Year

12

Month

09

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023228