Ignite Creation Date:
2025-12-24 @ 7:39 PM
Ignite Modification Date:
2025-12-26 @ 6:56 PM
Study NCT ID:
NCT01964703
Status:
COMPLETED
Last Update Posted:
2013-10-17
First Post:
2013-10-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Rubus Occidentalis Extract on Plasma Glucose Levels in Subject With Prediabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011236', 'term': 'Prediabetic State'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 29}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-10', 'lastUpdateSubmitDate': '2013-10-14', 'studyFirstSubmitDate': '2013-10-14', 'studyFirstSubmitQcDate': '2013-10-14', 'lastUpdatePostDateStruct': {'date': '2013-10-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-10-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'HOMA IR, QUICKI, HOMA beta, lipid profile, inflammatory markers', 'timeFrame': '12 weeks'}], 'primaryOutcomes': [{'measure': 'serum glucose (fasting and post 75g oral glucose tolerance test)', 'timeFrame': '12 weeks'}], 'secondaryOutcomes': [{'measure': 'serum insulin', 'timeFrame': '12 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Prediabetes (Impaired Fasting Glucose and/or Impaired Glucose Tolerance)']}, 'referencesModule': {'references': [{'pmid': '27279471', 'type': 'DERIVED', 'citation': 'An JH, Kim DL, Lee TB, Kim KJ, Kim SH, Kim NH, Kim HY, Choi DS, Kim SG. Effect of Rubus Occidentalis Extract on Metabolic Parameters in Subjects with Prediabetes: A Proof-of-concept, Randomized, Double-blind, Placebo-controlled Clinical Trial. Phytother Res. 2016 Oct;30(10):1634-1640. doi: 10.1002/ptr.5664. Epub 2016 Jun 9.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether Rubus occidentalis extract could improve fasting or postprandial serum glucose levels, and related metabolic markers among patients with prediabetes (impaired fasting glucose and/or impaired glucose tolerance).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 19 years of age or older\n* prediabetes (fasting plasma glucose 100-125mg/dl, and/or post 75g OGTT plasma glucose 140-199mg/dl)\n\nExclusion Criteria:\n\n* pregnant women\n* taking anti-hyperglycemic agents within 3 months at the time of enrollment\n* history of heart failure, myocardial infarction, cerebral infarction\n* uncontrolled hypertension (systolic BP \\> 160mmHg, or diastolic BP \\> 100mmHg)\n* serum triglyceride level \\> 500mg/dl\n* kidney dysfunction (serum Creatinine \\> 30% of upper normal limits)\n* hepatic dysfunction (AST, ALT \\> 3 times of upper normal limits)\n* taking systemic glucocorticoids within 1 month'}, 'identificationModule': {'nctId': 'NCT01964703', 'briefTitle': 'Effect of Rubus Occidentalis Extract on Plasma Glucose Levels in Subject With Prediabetes', 'organization': {'class': 'OTHER', 'fullName': 'Korea University Anam Hospital'}, 'officialTitle': 'Effect of Rubus Occidentalis Extract on Plasma Glucose Levels in Subject With Prediabetes; A Proof-of-concept, Randomized, Double-blind, Parallel-group Placebo-controlled Study', 'orgStudyIdInfo': {'id': 'ED13024'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'control'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Rubus occidentalis extract 900mg', 'description': 'taking Rubus occidentalis extract 900mg/day for 12weeks', 'interventionNames': ['Drug: Rubus occidentalis extract']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Rubus occidentalis extract 1800mg', 'description': 'taking Rubus occidentalis extract 1800mg/day for 12weeks', 'interventionNames': ['Drug: Rubus occidentalis extract']}], 'interventions': [{'name': 'Rubus occidentalis extract', 'type': 'DRUG', 'armGroupLabels': ['Rubus occidentalis extract 1800mg', 'Rubus occidentalis extract 900mg']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Korea University Anam Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Sin Gon Kim', 'investigatorAffiliation': 'Korea University Anam Hospital'}}}}