Japan Early Diabetes Intervention Study

Diabetes Mellitus Clinical Trial

— JEDIS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00464594
• Other study ID #: JEDIS ver.4.0
• Secondary ID: UMIN000000681
• Status: Recruiting
• Phase: N/A
• First received: April 19, 2007
• Last updated: April 22, 2007
• Start date: April 2007

Study information

• Verified date: April 2007
• Source: Japan Early Diabetes Intervention Study Group
• Contact: Kazuo Ichikawa
• Phone: 81-3-3814-8010
• Email: info[@]jedis2560.org
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2560
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 69 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Behavioral:
• Standard lifestyle guidance

Drug:
• Lifestyle guidance and monotherapy with acarbose

• Lifestyle guidance and monotherapy with metformin

• Lifestyle guidance and monotherapy with gliclazide

Locations

Country	Name	City	State
Japan	Tokyo Medical and Dental University	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Japan Early Diabetes Intervention Study Group

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	FPG >= 140mg/dl and HbA1c >= 7.0%

External Links

•   Link