UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000222 |
|---|---|
| Receipt number | R000000174 |
| Scientific Title | Japan Diabetes Complications Study |
| Date of disclosure of the study information | 2005/12/01 |
| Last modified on | 2005/09/13 15:58:05 |
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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
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
jdcstudy@md.tsukuba.ac.jp
Sponsor or person
Institute
Japan Diabetes Complications Study(JDCS) group
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000174
