NCT00464594

Brief Summary

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).

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,560

participants targeted

Target at P75+ for not_applicable diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2007

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

April 19, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 23, 2007

Completed
Last Updated

April 24, 2007

Status Verified

April 1, 2007

First QC Date

April 19, 2007

Last Update Submit

April 22, 2007

Conditions

Diabetes Mellitus

Keywords

Japan Early Diabetes Intervention Study

Outcome Measures

Primary Outcomes (1)

  • FPG >= 140mg/dl and HbA1c >= 7.0%

Interventions

Standard lifestyle guidanceBEHAVIORAL
Lifestyle guidance and monotherapy with acarboseDRUG
Lifestyle guidance and monotherapy with metforminDRUG
Lifestyle guidance and monotherapy with gliclazideDRUG

Eligibility Criteria

Age30 Years - 69 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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%

You may not qualify if:

  • 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
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tokyo Medical and Dental University

Tokyo, 113-8519, Japan

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

AcarboseMetforminGliclazide

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

TrisaccharidesOligosaccharidesPolysaccharidesCarbohydratesBiguanidesGuanidinesAmidinesOrganic ChemicalsBenzenesulfonamidesSulfonamidesAmidesSulfonylurea CompoundsUreaBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsSulfonesSulfur Compounds

Study Officials

  • Takeshi Kuzuya

    Jichi Medical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kazuo Ichikawa

CONTACT

81-3-3814-8010info@jedis2560.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 19, 2007

First Posted

April 23, 2007

Study Start

April 1, 2007

Last Updated

April 24, 2007

Record last verified: 2007-04

Locations

JP(1)