Japan Early Diabetes Intervention Study (JEDIS)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2007 by Japan Early Diabetes Intervention Study Group.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Japan Early Diabetes Intervention Study Group
ClinicalTrials.gov Identifier:
NCT00464594
First received: April 19, 2007
Last updated: April 22, 2007
Last verified: April 2007
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


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

Ages Eligible for Study:   30 Years to 69 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00464594     History of Changes
Other Study ID Numbers: JEDIS ver.4.0, UMIN000000681
Study First Received: April 19, 2007
Last Updated: April 22, 2007
Health Authority: Japan: Ministry of Health, Labor and Welfare

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
Gliclazide
Metformin
Acarbose
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 21, 2014