Japan Early Diabetes Intervention Study - Full Text View

Sponsored by:	Japan Early Diabetes Intervention Study Group
Information provided by:	Japan Early Diabetes Intervention Study Group
ClinicalTrials.gov Identifier:	NCT00464594

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

MedlinePlus related topics: Diabetes

Drug Information available for: Metformin Metformin hydrochloride Acarbose Gliclazide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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

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

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

Related Info This link exits the ClinicalTrials.gov site

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

Keywords provided by Japan Early Diabetes Intervention Study Group:

Japan Early Diabetes Intervention Study

Study placed in the following topic categories:

Acarbose
Metabolic Diseases
Gliclazide
Metformin
Disease Progression

Diabetes Mellitus
Endocrine System Diseases
Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders

Additional relevant MeSH terms:

Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009