UMIN-CTR Clinical Trial

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

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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025751