Ignite Creation Date:
2025-12-25 @ 3:24 AM
Ignite Modification Date:
2026-01-12 @ 9:38 AM
Study NCT ID:
NCT00567905
Status:
COMPLETED
Last Update Posted:
2009-01-13
First Post:
2007-12-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Green Tea Extract on Type 2 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2009-01-12', 'releaseDate': '2009-01-12'}, {'resetDate': '2009-01-27', 'releaseDate': '2009-01-13'}, {'resetDate': '2009-01-27', 'releaseDate': '2009-01-27'}, {'resetDate': '2009-02-25', 'releaseDate': '2009-01-30'}], 'estimatedResultsFirstSubmitDate': '2009-01-12'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D050177', 'term': 'Overweight'}], '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': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013662', 'term': 'Tea'}, {'id': 'D002482', 'term': 'Cellulose'}], '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'}, {'id': 'D005936', 'term': 'Glucans'}, {'id': 'D001704', 'term': 'Biopolymers'}, {'id': 'D011108', 'term': 'Polymers'}, {'id': 'D046911', 'term': 'Macromolecular Substances'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D001697', 'term': 'Biomedical and Dental Materials'}, {'id': 'D008420', 'term': 'Manufactured Materials'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-01', 'completionDateStruct': {'date': '2008-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-01-12', 'studyFirstSubmitDate': '2007-12-04', 'studyFirstSubmitQcDate': '2007-12-04', 'lastUpdatePostDateStruct': {'date': '2009-01-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-12-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Homeostasis model assessment for insulin resistance (HOMA-IR) was used as the major outcome measurement.', 'timeFrame': '16 weeks'}], 'secondaryOutcomes': [{'measure': 'HbA1C, blood sugar, creatinine, aminotransferases aspartate, aminotransferases alanine, uric acid, and plasma lipoproteins (triglyceride, cholesterol, cholesterol-HDL (HDL) and cholesterol-LDL (LDL)) cholesterol; BMI,WC---.', 'timeFrame': '16 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Type 2 Diabetes', 'Green tea extract', 'overweight'], 'conditions': ['Type 2 Diabetes']}, 'referencesModule': {'references': [{'pmid': '16416476', 'type': 'BACKGROUND', 'citation': 'Kao YH, Chang HH, Lee MJ, Chen CL. Tea, obesity, and diabetes. Mol Nutr Food Res. 2006 Feb;50(2):188-210. doi: 10.1002/mnfr.200500109.'}, {'pmid': '21649457', 'type': 'DERIVED', 'citation': 'Hsu CH, Liao YL, Lin SC, Tsai TH, Huang CJ, Chou P. Does supplementation with green tea extract improve insulin resistance in obese type 2 diabetics? A randomized, double-blind, and placebo-controlled clinical trial. Altern Med Rev. 2011 Jun;16(2):157-63.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to examine the effect of green tea extract (GTE) on type 2 diabetes and to explore the relationship between GTE and related hormone peptides.', 'detailedDescription': 'Green tea is one of the most popular beverages in the world. It is believed to have beneficial effects in prevention and treatment of many diseases, one of which is anti-obesity and anti-diabetes.\n\nThe benefit effects of green tea are mainly attributed to its polyphenol content, especially the most abundant one-epigallocatechin gallate (EGCG), which might inhibit adipocyte proliferation and differentiation in vitro studies\n\nWe hypothesized that GTE would improve insulin resistance in type 2 overweight diabetes and related hormone peptides will be influenced. Thus, we conducted this randomized clinical trial to examine the effect of GTE on type 2 diabetes and to explore the relationship between GTE and related hormone peptides.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Type 2 diabetes\n* Body mass index \\>25 kg/mm\n* Aged between 20 and 65 years\n* Being Chinese\n\nExclusion Criteria:\n\n* Aminotransferases aspartate or aminotransferases alanine \\> 80 IU/L, serum creatinine \\> 2.0 mg/dl,\n* Prolating or pregnant women, and patients with heart failure, acute myocardiac infarct, stroke and heavy injuries, and\n* Any other conditions not suitable for trial as evaluated by the physician.'}, 'identificationModule': {'nctId': 'NCT00567905', 'acronym': 'GTT-DM', 'briefTitle': 'Effect of Green Tea Extract on Type 2 Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'Taipei Hospital, Taiwan'}, 'officialTitle': 'Effect of Green Tea Extract on Type 2 Diabetes: a Randomized, Double-Blind, Placebo-Controlled Clinical Trial', 'orgStudyIdInfo': {'id': 'Tpe-2007-IRB-05'}, 'secondaryIdInfos': [{'id': 'NSC-96-2320-13-192-001'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A', 'description': 'Green tea extract', 'interventionNames': ['Dietary Supplement: Green tea extract']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'B', 'interventionNames': ['Dietary Supplement: Green tea extract']}], 'interventions': [{'name': 'Green tea extract', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['A:GTE (500 mg) tid/day', 'B:Placebo (cellulose, 500 mg) tid/day'], 'description': 'main content is epigallocatechin gallate (EGCG, 58%)', 'armGroupLabels': ['A', 'B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '886', 'city': 'Taipei', 'country': 'Taiwan', 'facility': 'Branch of Chinese Medicine, Taipei City Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}, {'zip': '886', 'city': 'Taipei', 'country': 'Taiwan', 'facility': 'Branch of Chinese Medicine', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'overallOfficials': [{'name': 'Chung-Hua Hsu, MD; PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Branch of Chinese Medicine, Taipei City Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Taipei Hospital, Taiwan', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Science and Technology Council, Taiwan', 'class': 'OTHER_GOV'}], 'responsibleParty': {'oldNameTitle': 'Chung-Hua Hsu', 'oldOrganization': 'Taipei Hospital'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2009-01-13', 'type': 'RELEASE'}, {'date': '2009-01-27', 'type': 'RESET'}, {'date': '2009-01-27', 'type': 'RELEASE'}, {'date': '2009-01-27', 'type': 'RESET'}, {'date': '2009-01-30', 'type': 'RELEASE'}, {'date': '2009-02-25', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Taipei Hospital (Chung-Hua Hsu)'}}}}