Ignite Creation Date:
2025-12-25 @ 12:39 AM
Ignite Modification Date:
2025-12-25 @ 10:49 PM
Study NCT ID:
NCT01360567
Status:
COMPLETED
Last Update Posted:
2013-04-30
First Post:
2011-05-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effect of Green Tea Extract on Type 2 Diabetes With Hyperlipidemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D006949', 'term': 'Hyperlipidemias'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013662', 'term': 'Tea'}], 'ancestors': [{'id': 'D028321', 'term': 'Plant Preparations'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D001628', 'term': 'Beverages'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 102}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-04', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-04-27', 'studyFirstSubmitDate': '2011-05-20', 'studyFirstSubmitQcDate': '2011-05-24', 'lastUpdatePostDateStruct': {'date': '2013-04-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-05-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent change of HOMA insulin resistance and TG', 'timeFrame': '16 weeks'}], 'secondaryOutcomes': [{'measure': 'Percent change of HbA1C and Cholesterol', 'timeFrame': '16 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['green tea', 'EGCG', 'type 2 diabetes', 'hyperlipidemia'], 'conditions': ['Type 2 Diabetes', 'Hyperlipidemia']}, 'referencesModule': {'references': [{'pmid': '18468736', 'type': 'BACKGROUND', 'citation': 'Hsu CH, Tsai TH, Kao YH, Hwang KC, Tseng TY, Chou P. Effect of green tea extract on obese women: a randomized, double-blind, placebo-controlled clinical trial. Clin Nutr. 2008 Jun;27(3):363-70. doi: 10.1016/j.clnu.2008.03.007. Epub 2008 May 12.'}, {'pmid': '24614112', 'type': 'DERIVED', 'citation': 'Liu CY, Huang CJ, Huang LH, Chen IJ, Chiu JP, Hsu CH. Effects of green tea extract on insulin resistance and glucagon-like peptide 1 in patients with type 2 diabetes and lipid abnormalities: a randomized, double-blinded, and placebo-controlled trial. PLoS One. 2014 Mar 10;9(3):e91163. doi: 10.1371/journal.pone.0091163. eCollection 2014.'}]}, 'descriptionModule': {'briefSummary': 'The aim of the study is to examine whether the extract of green tea is effective on type 2 diabetes and hyperlipidemia.', 'detailedDescription': 'Percent change Homa insulin resistance, cholesterol and triglycerol.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 20--69 years old\n* Type 2 diabetes for \\> one year\n* TG \\>= 150 mg/dl or LDL \\>= 100 mg/dl\n\nExclusion Criteria:\n\n* GPT \\> 80 mg/dl\n* Creatinine \\> 1.8 mg/dl\n* Pregnancy\n* AMI\n* Stroke\n* Operational or any not suitable patients diagnosis physician in charge'}, 'identificationModule': {'nctId': 'NCT01360567', 'briefTitle': 'The Effect of Green Tea Extract on Type 2 Diabetes With Hyperlipidemia', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Taipei City Hospital'}, 'officialTitle': 'Taipei City Hospital, Taipei, Taiwan', 'orgStudyIdInfo': {'id': '100002-63-020'}, 'secondaryIdInfos': [{'id': 'TCH-971103', 'type': 'OTHER_GRANT', 'domain': 'CCMP100-RD-014'}, {'id': 'TCHIRB-971103', 'type': 'OTHER_GRANT', 'domain': 'CCMP100-RD-014'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'B formula', 'description': 'placebo', 'interventionNames': ['Dietary Supplement: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'A formula', 'description': 'Green tea extract', 'interventionNames': ['Dietary Supplement: Green tea extract']}], 'interventions': [{'name': 'Green tea extract', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['EGCG: Green tea extract'], 'description': '500 mg . one capsule of green tea extract, 3 times per day', 'armGroupLabels': ['A formula']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': '500 mg . one capsule of placebo, 3 times per day', 'armGroupLabels': ['B formula']}]}, 'contactsLocationsModule': {'locations': [{'zip': '886', 'city': 'Taipei', 'country': 'Taiwan', 'facility': 'Chung-Hua Hsu', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}, {'zip': '886', 'city': 'Taipei', 'country': 'Taiwan', 'facility': 'Taipei City Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'overallOfficials': [{'name': 'Chung-Hua Hsu, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Taipei City Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Taipei City Hospital', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'National Yang Ming Chiao Tung University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'chief medical officer', 'investigatorFullName': 'Chung-Hua Hsu', 'investigatorAffiliation': 'Taipei City Hospital'}}}}