Ignite Creation Date:
2025-12-25 @ 12:10 AM
Ignite Modification Date:
2025-12-25 @ 10:11 PM
Study NCT ID:
NCT04233658
Status:
UNKNOWN
Last Update Posted:
2020-01-22
First Post:
2020-01-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Cynara Scolymus Extract for Treatment of Diabetes Mellitus Type 2
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000713175', 'term': 'artichoke leaf'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-05', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2022-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-01-20', 'studyFirstSubmitDate': '2020-01-15', 'studyFirstSubmitQcDate': '2020-01-16', 'lastUpdatePostDateStruct': {'date': '2020-01-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of HbA1c-level from baseline to week 12', 'timeFrame': '12 weeks'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetes Mellitus, Type 2']}, 'descriptionModule': {'briefSummary': "Edible parts of the artichoke plant (Cynara cardunculus, Cynara scolymus) are traditionally known in folk-medicine for lipid lowering and choleretic effects. Furthermore, antidiabetic effects are described. In the past year's research attributed health promoting effects to the main active compounds chlorogenic acid, luteolin and apigenin. Present literature indicates potential antidiabetic effects by different mechanisms like downregulation of gluconeogenesis, increased GLP-1 secretion and modification of insulin signalling. Up to now only few human clinical trials provide insufficient data to conclude the therapeutic potential of cynara scolymus extract in the treatment of type 2 diabetes.\n\nThe primary objective is to evaluate the antidiabetic effect and the mechanisms of glucose lowering by a 12-week treatment with a highly-standardized extract of cynara scolymus in subjects with diabetes mellitus type 2 compared to placebo."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female ≥18 years old.\n* Diagnosis of diabetes mellitus type 2 ≥ 90 days prior to screening\n* HbA1c-level between 6.5-9%\n* Body mass index of ≥ 28 kg/m2\n* Stable daily dose (for at least 30 days) of 1-3 oral antidiabetic drug (metformin, sulfonylurea, SGLT-2 inhibitor, thiazolidinedione or DPP-IV-inhibitor)\n\nExclusion Criteria:\n\n* Subjects with diabetes mellitus type 1 or history of ketoacidosis,\n* Uncontrolled diabetes, defined as fasting plasma glucose ≥20mmol/l or recurrent hypoglycemia (defined as capillary glucose values ≤3.5mmol/l)\n* Use of insulin or GLP-1-receptor agonists\n* Women wanting to become pregnant\n* Pregnant or breast-feeding women\n* Known hepatic disorder\n* Severe renal insufficiency (GFR ≤30ml/min)\n* History of inflammatory bowel disease\n* History of gastric bypass or gastric sleeve surgery\n* Anticoagulation with vitamin K-antagonists'}, 'identificationModule': {'nctId': 'NCT04233658', 'briefTitle': 'Cynara Scolymus Extract for Treatment of Diabetes Mellitus Type 2', 'organization': {'class': 'OTHER', 'fullName': 'Luzerner Kantonsspital'}, 'officialTitle': 'Cynara Scolymus Extract for Treatment of Diabetes Mellitus Type 2, a Pilot Clinical Trial Clinical Study Protocol', 'orgStudyIdInfo': {'id': '2020-17'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Cynara Scolymus', 'interventionNames': ['Drug: Cynara Scolymus']}], 'interventions': [{'name': 'Placebo', 'type': 'DRUG', 'description': '3x2 capsules / day', 'armGroupLabels': ['Placebo']}, {'name': 'Cynara Scolymus', 'type': 'DRUG', 'description': '3x2 capsules / day', 'armGroupLabels': ['Cynara Scolymus']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stefan Fischli', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Deputy Head Division of Endocrinology and Diabetes', 'investigatorFullName': 'Stefan Fischli', 'investigatorAffiliation': 'Luzerner Kantonsspital'}}}}