- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00464594
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
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 Contact
- Name: Kazuo Ichikawa
- Phone Number: 81-3-3814-8010
- Email: info@jedis2560.org
Study Locations
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-
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Tokyo, Japan, 113-8519
- Recruiting
- Tokyo Medical and Dental University
-
Contact:
- Phone Number: 03-3813-6111
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-
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 |
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FPG >= 140mg/dl and HbA1c >= 7.0%
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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
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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