UMIN-CTR Clinical Trial

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, diets, physical activity, mental health, meal times, breakfast skipping, snacking, snacking after dinner, late dinner, having dinner just before bedtime, alcohol consumption, smoking status, combined lifestyle risk factors, classical risk factors and prognosis (cardiovascular diseases, malignancy), the progression of atherosclerosis,diabetic microangiopathy, 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	Incident of cardiovascular events(include below a+b+c) a:ischemic heart disease(cardiac sudden death,acute myocardial infarction, unstable angina pectoris ,coronary arterial revascularization) b:cerebrovascular disease(cerebral infarction,cerebral hemorrhage,subarachnoid hemorrhage) c:total death
Key secondary outcomes	atherosclerotic diseases(ischemic heart disease, cerebrovascular disease, peripheral arterial disease) total death atherosclerotic diseases andtotal death atherosclerotic diseases and cardiovasuclar death malignancy incidence and/or progression of diabetic retinopathy incidence and/or progression of diabetic nephropahty renal function decline 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	736
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	2013 Year 05 Month 27 Day
Anticipated trial start date	2013 Year 06 Month 15 Day
Last follow-up date	2022 Year 04 Month 30 Day
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	2022 Year 04 Month 25 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012771