UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000010932
Receipt number 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 2022/04/25 14:49:18

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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 or person

Institute

Juntendo University Graduate School of Medicine

Institute

Department

Personal name



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

Value
https://center6.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