UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000010932
Receipt No. R000012771
Scientific Title The relationships between lifestyle and prognosis, organ damage,metabolism in patients with type 2 diabetes mellitus(Cohort study)
Date of disclosure of the study information 2013/06/15
Last modified on 2018/06/15

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title The relationships between lifestyle and prognosis, organ damage,metabolism in patients with type 2 diabetes mellitus(Cohort study)
Acronym The relationships between lifestyle and prognosis, organ damage,metabolism in patients with type 2 diabetes mellitus(Cohort study)
Scientific Title The relationships between lifestyle and prognosis, organ damage,metabolism in patients with type 2 diabetes mellitus(Cohort study)
Scientific Title:Acronym The relationships between lifestyle and prognosis, organ damage,metabolism in patients with type 2 diabetes mellitus(Cohort study)
Region
Japan

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

Objectives
Narrative objectives1 We investigated the relationships between lifestyle pattern such as morningness-eveningness, sleep, total intake calories, physical activity, mental health, and the progression of atherosclerosis, renal damage, metabolic parameters in type 2 diabetes patients.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes To evaluate the incident of cardiovascular event(include below a+b+c)
a:ischemic heart disease(cardiac sudden death,acute myocardial infarction,unstable angina pectoris,undergo CABG)
b:cerebrovascular disease(cerebral infarction,cerebral hemorrhage,subarachnoid hemorrhage)
c:total death
Key secondary outcomes baPWV
albuminuria
metabolic parameters
life styles

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
25 years-old <=
Age-upper limit
70 years-old >
Gender Male and Female
Key inclusion criteria Type 2 diabetes outpatient hospital
Key exclusion criteria patient meeting one of the following conditions will be excluded
1) type 1 and secondariy diabetes
2) severe infectious disease, before or after surgery, and sever trauma
3) events of myocardial infarction,angina pectoris, cerebral stroke,and cerebral infarction
4)receiving dialysis
5)cirrhosis
6)moderate or severe heart failure (NYHA/New York Heart Association stage3 or severe)
7)pregnant,lactating,and possibly pregnant women
8)malignancy
9)judged as ineligible by clinical investigators
Target sample size 736

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yusuke OSONOI
Organization Juntendo University Graduate School of Medicine
Division name Department of Medicine, Metabolism and Endocrinology
Zip code
Address 2-1-1 Hongo, Bunkyo-KU, Tokyo
TEL 03-3813-3111
Email y-osonoi@juntendo.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yusuke OSONOI
Organization Juntendo University Graduate School of Medicine
Division name Department of Medicine, Metabolism and Endocrinology
Zip code
Address 2-1-1 Hongo, Bunkyo-KU, Tokyo
TEL 03-3813-3111
Homepage URL
Email y-osonoi@juntendo.ac.jp

Sponsor
Institute Juntendo University Graduate School of Medicine
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
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
2013 Year 06 Month 15 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 No longer recruiting
Date of protocol fixation
2013 Year 05 Month 27 Day
Date of IRB
Anticipated trial start date
2013 Year 06 Month 15 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information We investgiated the relationships between characteristics of study subjects and the incident of events (ischemic heart disease, cerebrovascular disease,and total death)

Management information
Registered date
2013 Year 06 Month 11 Day
Last modified on
2018 Year 06 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012771

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.