UMIN-CTR Clinical Trial

Basic information
Public title	Medication adherence and continuity of care (Observational study of impact of medication adherence on renal function in comorbid patients with type 2 diabetes and depression)
Acronym	Observational study on diabetes and depression
Scientific Title	Medication adherence and continuity of care (Observational study of impact of medication adherence on renal function in comorbid patients with type 2 diabetes and depression)
Scientific Title:Acronym	Observational study on diabetes and depression
Region	Japan

Condition
Condition	Diabetes and depression
Classification by specialty	Endocrinology and Metabolism Psychiatry
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine depression as a predictor of renal function decline, and how adherence to hypoglycemic medication relates to depression and renal function decline in patients with type 2 diabetes
Basic objectives2	Others
Basic objectives -Others	Decline of renal function in subtypes categorized according to depression and adherence
Trial characteristics_1	Exploratory
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	Decline of renal function in subtypes categorized according to depression and adherence
Key secondary outcomes	Clinical variables, quality of life, and attitude of physicians toward depression

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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Outpatients with type 2 diabetes receiving hypoglycemic medications who can complete a questionnaire in Japanese.
Key exclusion criteria	Patients pregnant, with cognitive impairment, severe disease of the adrenal glands, liver dysfunction, or severe renal impairment (serum creatinine > 2.0 mg/dL)
Target sample size	550

Research contact person
Name of lead principal investigator	1st name Megumi Middle name Last name Hazumi
Organization	National Center of Neurology and Psychiatry
Division name	Department of Mental Health Policy and Evaluation, National Institute of Mental Health
Zip code	187-0031
Address	4-1-1 Ogawa-Higashi, Kodaira, Tokyo
TEL	042-341-2711
Email	ItoHiroto@ncnp.go.jp

Public contact
Name of contact person	1st name Megumi Middle name Last name Hazumi
Organization	National Center of Neurology and Psychiatry
Division name	Department of Mental Health Policy and Evaluation, National Institute of Mental Health
Zip code	187-0031
Address	4-1-1 Ogawa-Higashi, Kodaira, Tokyo
TEL	042-341-2711
Homepage URL
Email	mhazumi@ncnp.go.jp

Sponsor
Institute	National Center of Neurology and Psychiatry
Institute
Department

Funding Source
Organization	National Center of Neurology and Psychiatry
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	National Center of Neurology and Psychiatry
Address	4-1-1 Ogawa-Higashi, Kodaira, Tokyo
Tel	042-341-2711
Email	mhazumi@ncnp.go.jp

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	国立精神・神経医療研究センター病院（東京都）、京都医療センター（京都府）、医療法人社団シマダ嶋田病院（福岡県）、自治医科大学病院（栃木県）、大阪赤十字病院（大阪府）、松原病院（福井県）、不知火病院（福岡県）、草津病院（広島県）、可也病院（福岡県）、仁大病院（愛知県）、養南病院（岐阜県）、阪南病院（大阪府）、しのだの森ホスピタル（千葉県）、宇治おうばく病院（京都府）、あさかホスピタル（福島県）、東京医科大学（東京都）、久留米大学（福岡県）、聖ルチア病院（福岡県）、たかむきメンタルクリニック（福岡県）、宮の陣病院（福岡県）、広田クリニック（福岡県）、のぞえ総合心療病院（福岡県）

Other administrative information
Date of disclosure of the study information	2015 Year 05 Month 22 Day

Related information
URL releasing protocol	http://www.biomedcentral.com/1471-2296/16/124/prepub
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	2015 Year 05 Month 22 Day
Date of IRB	2015 Year 07 Month 08 Day
Anticipated trial start date	2015 Year 09 Month 01 Day
Last follow-up date	2017 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete	2018 Year 03 Month 31 Day
Date analysis concluded

Other
Other related information	Observational study

Management information
Registered date	2015 Year 05 Month 12 Day
Last modified on	2020 Year 05 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000020301