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Japan Early Diabetes Intervention Study (JEDIS)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2007 by Japan Early Diabetes Intervention Study Group.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00464594
First Posted: April 23, 2007
Last Update Posted: April 24, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Japan Early Diabetes Intervention Study Group
  Purpose
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).

Condition Intervention
Diabetes Mellitus Behavioral: Standard lifestyle guidance Drug: Lifestyle guidance and monotherapy with acarbose Drug: Lifestyle guidance and monotherapy with metformin Drug: Lifestyle guidance and monotherapy with gliclazide

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Comparative Clinical Study on Suppression of Progression From Early Diabetes, Diet/Exercise Standard Intervention vs. Concurrent Pharmacological Standard Intervention

Further study details as provided by Japan Early Diabetes Intervention Study Group:

Primary Outcome Measures:
  • FPG >= 140mg/dl and HbA1c >= 7.0%

Estimated Enrollment: 2560
Study Start Date: April 2007
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 69 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00464594


Contacts
Contact: Kazuo Ichikawa 81-3-3814-8010 info@jedis2560.org

Locations
Japan
Tokyo Medical and Dental University Recruiting
Tokyo, Japan, 113-8519
Contact    03-3813-6111      
Sponsors and Collaborators
Japan Early Diabetes Intervention Study Group
Investigators
Principal Investigator: Takeshi Kuzuya Jichi Medical University
  More Information

ClinicalTrials.gov Identifier: NCT00464594     History of Changes
Other Study ID Numbers: JEDIS ver.4.0
UMIN000000681
First Submitted: April 19, 2007
First Posted: April 23, 2007
Last Update Posted: April 24, 2007
Last Verified: April 2007

Keywords provided by Japan Early Diabetes Intervention Study Group:
Japan Early Diabetes Intervention Study

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Acarbose
Gliclazide
Glycoside Hydrolase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Hypoglycemic Agents
Physiological Effects of Drugs