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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000032325
Receipt No. R000036396
Scientific Title A prospective observational study to investigate the relationship between glucose fluctuation and a subsequent incidence of cardiovascular events in patients with type 2 diabetes
Date of disclosure of the study information 2018/04/20
Last modified on 2018/04/20

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Basic information
Public title A prospective observational study to investigate the relationship between glucose fluctuation and a subsequent incidence of cardiovascular events in patients with type 2 diabetes
Acronym glucose fluctuation and cardiovascular events
Scientific Title A prospective observational study to investigate the relationship between glucose fluctuation and a subsequent incidence of cardiovascular events in patients with type 2 diabetes
Scientific Title:Acronym glucose fluctuation and cardiovascular events
Region
Japan

Condition
Condition type 2 diabetes
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We aim at investigating the relationship between glucose fluctuation evaluated by continous glucose monitering with use of FreeStyle Libre Pro and the incidence of composite cardiovascular events or the progression of atherosclerosis in T2DM patients who had no apparent history of CVD.
Basic objectives2 Others
Basic objectives -Others We aim at investigating the relationship between glucose fluctuation evaluated by continous glucose monitering with use of FreeStyle Libre Pro and clinical parameters including atherosclerosis markers in T2DM patients who had no apparent history of CVD in a cross-sectional study.
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes The primary study outcome is to investigate the relationships between fluctuations in glucose levels evaluated by continuous glucose monitoring and the incidence of composite cardiovascular events including cardiovascular death, acute myocardial infarction, unstable angina pectoris, revascularization for the treatment of coronary artery diseases, ischemic stroke, or revascularization for the treatment of arteriosclerosis obliterans.
Key secondary outcomes 1) the relationships between fluctuations in glucose levels evaluated by continuous glucose monitoring and the incidence of composite cardiovascular events (a, b or c, or each of a,b and c)
a)heart diseases (cardiovascular death, acute myocardial infarction, unstable angina pectoris, revascularization for the treatment of coronary artery diseases or hospitalization for heart failure)
b)cerebrovascular diseases (ischemic stroke, hemorrhagic stroke or subarachnoid haemorrhage)
c)artery diseases (arteriosclerosis obliterans, revascularization for the treatment of arteriosclerosis obliterans or lower limb amputation)
2) the relationships between fluctuations in glucose levels evaluated by continuous glucose monitoring and the incidence of malignant tumors,
3) the relationships between fluctuations in glucose levels evaluated by continuous glucose monitoring and all-cause mortality in addition to a) plus b) plus c) as described above.
4) the relationships between fluctuations in glucose levels evaluated by continuous glucose monitoring, and cardiovascular death, myocardial infarction or stroke.
5) the relationships between fluctuations in glucose levels evaluated by continuous glucose monitoring, and cardiovascular death, myocardial infarction, unstable angina, or stroke.
6) the relationships between fluctuations in glucose levels evaluated by continuous glucose monitoring, and development or progression of diabetic retinopathy or nephropathy.
7) the relationships between fluctuations in glucose levels evaluated by continuous glucose monitoring, and changes in mean carotid intima media thickness, max carotid intima media thickness, gray-scale median, or brachial-ankle pulse wave velocity.
8) the relationships between fluctuations in glucose levels evaluated by continuous glucose monitoring, and changes in Diabetes Therapy-Related QOL scores or Pittsburgh Sleep Quality Index scores.
etc.


Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
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

Eligibility
Age-lower limit
30 years-old <=
Age-upper limit
80 years-old >=
Gender Male and Female
Key inclusion criteria 1)30 years of age or older and 80 years of age or younger(regardless of gender)
2)T2DM patients treated at the outpatient clinic.
3)signing consent form for participation in the study.
4)No changes (including new prescriptions) in their antidiabetic medication for at least 4 weeks before FreeStyle Libre Pro sensors were applied at the back of the upper arm of each participant.
Key exclusion criteria 1)patients with type 1 or secondary diabetes
2)presence of severe infectious disease, before or after surgery, or severe trauma, 3)history of myocardial infarction, angina pectoris, cerebral stroke, or cerebral infarction, or arteriosclerosis obliterans4)patients undergoing artificial dialysis5)moderate liver dysfunction (aspartate aminotransferase 100 IU/l or more)
6)moderate or severe heart failure (NYHA/New York Heart Association stage III or severer)
7)patients with pregnant, lactating, or possibly pregnant women, or those planning to become pregnant during the study period
8) Present or past history of a malignant tumor (exception: those not on medication for malignant tumor and with no recurrence of the disease to date and without recurrence risks during this study were allowed to participate.)
9) patients with use of Sensor Augmented Pump
10) patients judged as ineligible by the clinical investigators.
Target sample size 1000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hirotaka Watada
Organization Juntendo University Graduate School of Medicine
Division name Department of Metabolism & Endocrinology
Zip code
Address Hongo 2-1-1, Bunkyo-ku, Tokyo
TEL 03-5802-1579
Email hwatada@juntendo.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tomoya Mita
Organization Juntendo University Graduate School of Medicine
Division name Department of Metabolism & Endocrinology
Zip code
Address Hongo 2-1-1, Bunkyo-ku, Tokyo
TEL 03-5802-1579
Homepage URL
Email tom-m@juntendo.ac.jp

Sponsor
Institute Juntendo University Graduate School of Medicine
Institute
Department

Funding Source
Organization Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2018 Year 04 Month 20 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
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

Progress
Recruitment status Preinitiation
Date of protocol fixation
2018 Year 04 Month 16 Day
Date of IRB
Anticipated trial start date
2018 Year 04 Month 21 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information This is as observational study.

Management information
Registered date
2018 Year 04 Month 20 Day
Last modified on
2018 Year 04 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036396

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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