UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000022363
Receipt number R000025751
Scientific Title Analysis of the impact of positive psychology and occupation on glycemic control and diabetic complications of diabetics
Date of disclosure of the study information 2016/05/20
Last modified on 2022/05/31 14:10:48

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Basic information

Public title

Analysis of the impact of positive psychology and occupation on glycemic control and diabetic complications of diabetics

Acronym

Analysis of the impact of positive psychology and occupation on glycemic control and diabetic complications of diabetics

Scientific Title

Analysis of the impact of positive psychology and occupation on glycemic control and diabetic complications of diabetics

Scientific Title:Acronym

Analysis of the impact of positive psychology and occupation on glycemic control and diabetic complications of diabetics

Region

Japan


Condition

Condition

type 2 diabetes

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

This study is aimed to research for the effect of positive psychology and occupation to diabetic complications and glycemic control in type 2 diabetic patients.

Basic objectives2

Others

Basic objectives -Others

This study is a prospective observation study to research for the effect of positive psychology and occupation to the progression of diabetic complications and glycemic control in type 2 diabetic patients.

Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

the relation between positive psychology,occupation and the below.

1 diabetic nephropathy
2 diabetic retinopathy
3 diabetic neuropathy
4 ischemic heart diseases and stroke
5 glycemic control

Key secondary outcomes

the relation between positive psychology,occupation and the below.

1 baPWV,ABI
2 the plaque or IMT of carotid artery with ultrasonography examination
3 coefficient of variation of R-R interval , nerve conduction study


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

40 years-old <=

Age-upper limit

80 years-old >

Gender

Male and Female

Key inclusion criteria

Type 2 diabetics at Osaka University Hospital in Japan

Key exclusion criteria

Patients who decline to be enrolled in this study

Target sample size

350


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Ninomiya Hiroyo

Organization

Graduate School of Medicine, Osaka University

Division name

Metabolic Medicine

Zip code


Address

2-2-B5, Yamada-oka, Suita, Osaka, Japan

TEL

06-6879-3737

Email

hiro-n@endmet.med.osaka-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Ninomiya Hiroyo

Organization

Graduate School of Medicine, Osaka University

Division name

Metablic Medicine

Zip code


Address

2-2-B5, Yamada-oka, Suita, Osaka, Japan

TEL

06-6879-3737

Homepage URL


Email

hiro-n@endmet.med.osaka-u.ac.jp


Sponsor or person

Institute

Department of Metabolic Medicine, Graduate School of Medicine, Osaka University

Institute

Department

Personal name



Funding Source

Organization

Ministry of Health, Labour and Welfare

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

2016 Year 05 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

Completed

Date of protocol fixation

2014 Year 08 Month 22 Day

Date of IRB

2014 Year 08 Month 22 Day

Anticipated trial start date

2014 Year 08 Month 28 Day

Last follow-up date

2019 Year 12 Month 13 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded

2022 Year 02 Month 28 Day


Other

Other related information

This study is a prospective observation study,and the observation period is designed for 4 years. we analysis the relation among the positive psychology,diabetic complications,and glycemic control.


Management information

Registered date

2016 Year 05 Month 19 Day

Last modified on

2022 Year 05 Month 31 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025751


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name