UMIN-CTR Clinical Trial

Public title

Japan Diabetes Complications Study

Acronym

JDCS

Scientific Title

Japan Diabetes Complications Study

Scientific Title:Acronym

JDCS

Region

Japan

Condition

diabetes mellitus

Classification by specialty

Medicine in general	Cardiology	Endocrinology and Metabolism
Nephrology	Neurology	Ophthalmology

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Interventional

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

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

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

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

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

Institute

Japan Diabetes Complications Study(JDCS) group

Institute

Department

Personal name

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

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2005

Year

12

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related 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