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Japan Early Diabetes Intervention Study

NCT ID: NCT00464594

Last Updated: 2007-04-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

2560 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-04-30

Brief Summary

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The purpose of this study is to compare the suppressive effect of two kinds of interventions on the worsening/progression to definite diabetes: standard lifestyle guidance and standard lifestyle guidance combined with pharmacological intervention (monotherapy with one of acarbose, metformin, or gliclazide).

Detailed Description

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In newly-diagnosed early diabetes patients, a randomized comparative study will be conducted to compare the suppressive effect of the following two kinds of interventions on the worsening/progression to definite diabetes which has a harmful hyperglycemia i.e. an increased risk of microangiopathy: standard education for the improvement of lifestyle in accordance with the "Guidelines for the Treatment of Diabetes Mellitus in Japan" of the Japan Diabetes Society (JDS) and standard lifestyle guidance combined with pharmacological intervention using the lowest possible dose of commercially available oral hypoglycemic agents (one of acarbose, metformin, or gliclazide) in Japan.

Conditions

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Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Standard lifestyle guidance

Intervention Type BEHAVIORAL

Lifestyle guidance and monotherapy with acarbose

Intervention Type DRUG

Lifestyle guidance and monotherapy with metformin

Intervention Type DRUG

Lifestyle guidance and monotherapy with gliclazide

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Results of 75-g oral glucose tolerance test (75 g OGTT)will be used to confirm FPG \<= 125 mg/dL, 2-h PG \>= 200 mg/dL and HbA1c \<= 6.9%

Exclusion Criteria

* Type 1 diabetes mellitus
* Undergoing treatment with steroids
* Secondary diabetes mellitus
* Diabetes mellitus due to suspected gene abnormalities
* BMI \>= 35 kg/m2 or BMI \< 18.5 kg/m2
* Undergone a surgery
* Severe hyperuricemia (gout) associated with organ dysfunction
* Severe vascular diseases with organ dysfunction
* Cancer or other malignant neoplasms
* Liver cirrhosis or chronic hepatic, chronic renal failure
* Gastrointestinal disorders
* Always performing rigorous muscular exercise
* Severe infection or serious trauma
* Women who are pregnant
* Alcohol dependence or drug dependence
* Drug allergy
* Anemic
* Abnormal hemoglobinuria
* Severe mental disease
Minimum Eligible Age

30 Years

Maximum Eligible Age

69 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Japan Early Diabetes Intervention Study Group

OTHER

Sponsor Role lead

Principal Investigators

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Takeshi Kuzuya

Role: PRINCIPAL_INVESTIGATOR

Jichi Medical University

Locations

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Tokyo Medical and Dental University

Tokyo, , Japan

Site Status RECRUITING

Countries

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Japan

Central Contacts

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Kazuo Ichikawa

Role: CONTACT

[email protected]
81-3-3814-8010

Facility Contacts

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Role: primary

03-3813-6111

Other Identifiers

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UMIN000000681

Identifier Type: -

Identifier Source: secondary_id

JEDIS ver.4.0

Identifier Type: -

Identifier Source: org_study_id