Ignite Creation Date:
2025-12-25 @ 1:45 AM
Ignite Modification Date:
2025-12-26 @ 12:03 AM
Study NCT ID:
NCT00464594
Status:
UNKNOWN
Last Update Posted:
2007-04-24
First Post:
2007-04-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Japan Early Diabetes Intervention Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D020909', 'term': 'Acarbose'}, {'id': 'D008687', 'term': 'Metformin'}, {'id': 'D005907', 'term': 'Gliclazide'}], 'ancestors': [{'id': 'D014312', 'term': 'Trisaccharides'}, {'id': 'D009844', 'term': 'Oligosaccharides'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D001645', 'term': 'Biguanides'}, {'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000096926', 'term': 'Benzenesulfonamides'}, {'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D013453', 'term': 'Sulfonylurea Compounds'}, {'id': 'D014508', 'term': 'Urea'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 2560}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2007-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-04', 'lastUpdateSubmitDate': '2007-04-22', 'studyFirstSubmitDate': '2007-04-19', 'studyFirstSubmitQcDate': '2007-04-19', 'lastUpdatePostDateStruct': {'date': '2007-04-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-04-23', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'FPG >= 140mg/dl and HbA1c >= 7.0%'}]}, 'conditionsModule': {'keywords': ['Japan Early Diabetes Intervention Study'], 'conditions': ['Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': '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).', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '69 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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%\n\nExclusion Criteria:\n\n* Type 1 diabetes mellitus\n* Undergoing treatment with steroids\n* Secondary diabetes mellitus\n* Diabetes mellitus due to suspected gene abnormalities\n* BMI \\>= 35 kg/m2 or BMI \\< 18.5 kg/m2\n* Undergone a surgery\n* Severe hyperuricemia (gout) associated with organ dysfunction\n* Severe vascular diseases with organ dysfunction\n* Cancer or other malignant neoplasms\n* Liver cirrhosis or chronic hepatic, chronic renal failure\n* Gastrointestinal disorders\n* Always performing rigorous muscular exercise\n* Severe infection or serious trauma\n* Women who are pregnant\n* Alcohol dependence or drug dependence\n* Drug allergy\n* Anemic\n* Abnormal hemoglobinuria\n* Severe mental disease'}, 'identificationModule': {'nctId': 'NCT00464594', 'acronym': 'JEDIS', 'briefTitle': 'Japan Early Diabetes Intervention Study', 'organization': {'class': 'OTHER', 'fullName': 'Japan Early Diabetes Intervention Study Group'}, 'officialTitle': 'A Randomized Comparative Clinical Study on Suppression of Progression From Early Diabetes, Diet/Exercise Standard Intervention vs. Concurrent Pharmacological Standard Intervention', 'orgStudyIdInfo': {'id': 'JEDIS ver.4.0'}, 'secondaryIdInfos': [{'id': 'UMIN000000681'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Standard lifestyle guidance', 'type': 'BEHAVIORAL'}, {'name': 'Lifestyle guidance and monotherapy with acarbose', 'type': 'DRUG'}, {'name': 'Lifestyle guidance and monotherapy with metformin', 'type': 'DRUG'}, {'name': 'Lifestyle guidance and monotherapy with gliclazide', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '113-8519', 'city': 'Tokyo', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'role': 'CONTACT', 'phone': '03-3813-6111'}], 'facility': 'Tokyo Medical and Dental University', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}], 'centralContacts': [{'name': 'Kazuo Ichikawa', 'role': 'CONTACT', 'email': 'info@jedis2560.org', 'phone': '81-3-3814-8010'}], 'overallOfficials': [{'name': 'Takeshi Kuzuya', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Jichi Medical University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Japan Early Diabetes Intervention Study Group', 'class': 'OTHER'}}}}