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Japan Early Diabetes Intervention Study

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00464594
Acronym
JEDIS
Enrollment
2560
Registered
2007-04-23
Start date
2007-04-30
Completion date
Unknown
Last updated
2007-04-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus

Keywords

Japan Early Diabetes Intervention Study

Brief 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).

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.

Interventions

BEHAVIORALStandard lifestyle guidance
DRUGLifestyle guidance and monotherapy with acarbose
DRUGLifestyle guidance and monotherapy with metformin
DRUGLifestyle guidance and monotherapy with gliclazide

Sponsors

Japan Early Diabetes Intervention Study Group
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
30 Years to 69 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
FPG >= 140mg/dl and HbA1c >= 7.0%—

Countries

Japan

Contacts

Primary ContactKazuo Ichikawa
info@jedis2560.org81-3-3814-8010

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026