Japan Early Diabetes Intervention Study (JEDIS)

April 22, 2007 updated by: Japan Early Diabetes Intervention Study Group

A Randomized Comparative Clinical Study on Suppression of Progression From Early Diabetes, Diet/Exercise Standard Intervention vs. Concurrent Pharmacological Standard Intervention

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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment

2560

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Tokyo, Japan, 113-8519
        • Recruiting
        • Tokyo Medical and Dental University
        • Contact:
          • Phone Number: 03-3813-6111

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 69 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
FPG >= 140mg/dl and HbA1c >= 7.0%

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Japan Early Diabetes Intervention Study Group

Investigators

  • Principal Investigator: Takeshi Kuzuya, Jichi Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2007

Study Registration Dates

First Submitted

April 19, 2007

First Submitted That Met QC Criteria

April 19, 2007

First Posted (Estimate)

April 23, 2007

Study Record Updates

Last Update Posted (Estimate)

April 24, 2007

Last Update Submitted That Met QC Criteria

April 22, 2007

Last Verified

April 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JEDIS ver.4.0
  • UMIN000000681

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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