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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN C000000222
Receipt No. R000000174
Scientific Title Japan Diabetes Complications Study
Date of disclosure of the study information 2005/12/01
Last modified on 2005/09/13

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Basic information
Public title Japan Diabetes Complications Study
Acronym JDCS
Scientific Title Japan Diabetes Complications Study
Scientific Title:Acronym JDCS
Region
Japan

Condition
Condition diabetes mellitus
Classification by specialty
Medicine in general Cardiology Endocrinology and Metabolism
Nephrology Neurology Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 1) To determine whether long-term lifestyle intervention can improve glycemic control and prevent complications in patients with type 2 diabetes

2) To clarify pathophysiological characteristics of Japanese patients with type 2 diabetes and current situation of their management/care.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Parameters and indices related to glycemic control, diabetic complications, dyslipidemia, hypertension, obesity and atherosclerosis were measured several times a year.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification NO
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Behavior,custom
Interventions/Control_1 The patients in the control group received regular conventional care of diabetologists without any changes before or during the study period.
Interventions/Control_2 1) For patients in the intervention group, dietary habits, physical activities and adherence to the treatments were managed intensively during outpatient clinic visits in addition to routine conventional treatment.

2) Treatment goals were set for patients in the intervention group regarding weight, glycemic, blood pressure, and serum lipid control, smoking, alcohol drinking, etc.

3) Patients in the intervention group also received telephone counseling sessions by trained educators. Patients in the intervention group received educational materials discussing various aspects of diabetes care.
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
70 years-old >
Gender Male and Female
Key inclusion criteria 1) Patients with previously diagnosed type 2 diabetes with HbA1c levels of more than 6.5%.

2) the mean value of two spot urine examinations for albumin excretion rate was less than 150 mg/g creatinine for all patients.
Key exclusion criteria Patients with serum creatinine levels greater than 1.3 mg/dl, nephrotic syndrome, history of angina pectoris and/or myocardial infarction, ischemic cerebral vascular events, arteriosclerosis obliterans, familial hypercholesterolemia or type III hyperlipidemia were excluded as subjects for macroangiopathy analysis.

With regard to microangiopathy analysis, patients with a history of intra-ocular surgeries or non-diabetic nephropathy were excluded. The patients studied had no baseline diabetic retinopathy (subjects for primary retinopathy prevention analysis) or minimal background retinopathy (subjects for secondary retinopathy prevention analysis).
Target sample size 2000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Nobuhiro Yamada, MD, PhD
Organization University of Tsukuba Institute of Clinical Medicine
Division name Department of Endocrinology, Metabolism and Diabetology
Zip code
Address 1-1-1 Tennodai, Tsukuba, Ibaraki, Japan (305-8575)
TEL 029-853-3053
Email

Public contact
Name of contact person
1st name
Middle name
Last name Hirohito Sone, MD, PhD, FACP
Organization University of Tsukuba Institute of Clinical Medicine
Division name Department of Endocrinology, Metabolism and Diabetology
Zip code
Address 1-1-1 Tennodai, Tsukuba, Ibaraki, Japan (305-8575)
TEL 029-853-3053
Homepage URL
Email jdcstudy@md.tsukuba.ac.jp

Sponsor
Institute Japan Diabetes Complications Study(JDCS) group
Institute
Department

Funding Source
Organization The Health Sciences Research Grants (Research on Health Services),Ministry of Health Labor and Welfare, Japan
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

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
2005 Year 12 Month 01 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 No longer recruiting
Date of protocol fixation
1995 Year 12 Month 01 Day
Date of IRB
Anticipated trial start date
1996 Year 01 Month 01 Day
Last follow-up date
2010 Year 12 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2005 Year 09 Month 13 Day
Last modified on
2005 Year 09 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000174

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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