Ignite Creation Date:
2025-12-24 @ 10:54 PM
Ignite Modification Date:
2026-01-03 @ 11:08 PM
Study NCT ID:
NCT02529969
Status:
UNKNOWN
Last Update Posted:
2015-08-20
First Post:
2015-08-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Curcumin Supplementation on Lipid Profile and Inflammatory Markers of Patients With Type 2 Diabetes
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': 'D003474', 'term': 'Curcumin'}], 'ancestors': [{'id': 'D036381', 'term': 'Diarylheptanoids'}, {'id': 'D006536', 'term': 'Heptanes'}, {'id': 'D000473', 'term': 'Alkanes'}, {'id': 'D006839', 'term': 'Hydrocarbons, Acyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D002396', 'term': 'Catechols'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-07', 'lastUpdateSubmitDate': '2015-08-19', 'studyFirstSubmitDate': '2015-08-19', 'studyFirstSubmitQcDate': '2015-08-19', 'lastUpdatePostDateStruct': {'date': '2015-08-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-08-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Triglyceride', 'timeFrame': '12 weeks'}], 'secondaryOutcomes': [{'measure': 'C-Reactive Protein', 'timeFrame': '12 weeks'}]}, 'conditionsModule': {'conditions': ['Non Insulin Dependent Diabetes']}, 'descriptionModule': {'briefSummary': 'Diabetes mellitus is the most common endocrine disorder, causes many complications such as micro- and macro-vascular diseases. Various kinds of antidiabetic drugs have been developed, but most of them have side effects. Recently, the use of natural plant products has gained more attention among scientists in order to prevent diabetic vascular complications. Curcumin is a natural yellow product derived from the turmeric rhizome which has shown to be non-toxic and exhibits various bio¬logical activities such as anti-oxidant, anti-inflammatory, anti-carcinogenic, and anti-diabetic effects. Curcumin is effective in reducing glycemic index and hyperlipidemia in rodent models and is relatively inexpensive and safe. Most of the studies conducted on animal model, and just a few of them are on human model. The present study was planned to evaluate the effects of curcumin supplementation on serum levels of lipid profile and inflammatory markers in patients with type 2 diabetes'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Tendency to participate\n2. Age range of 40-65\n3. Suffering from diabetes type 2 ( between 1 to 10 yeares)\n4. BMI 18/5-30\n5. Patients with diabetes who administer oral hypoglycemic agents and do not use\n\nExclusion Criteria:\n\n1. patients with liver diseases\n2. patients with kidney diseases\n3. patients with inflammatory diseases\n4. patients with liver diseases\n5. Administering herbal agents\n6. Administering multivitamins and minerals in past 3 months'}, 'identificationModule': {'nctId': 'NCT02529969', 'briefTitle': 'Effects of Curcumin Supplementation on Lipid Profile and Inflammatory Markers of Patients With Type 2 Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'National Nutrition and Food Technology Institute'}, 'officialTitle': 'Curcumin Supplementation and Type 2 Diabetes', 'orgStudyIdInfo': {'id': '615'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'intervention', 'description': '500 mg curcumin capsule', 'interventionNames': ['Dietary Supplement: curcumin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'description': '500 mg placebo', 'interventionNames': ['Dietary Supplement: Placebo']}], 'interventions': [{'name': 'curcumin', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['intervention']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19435', 'city': 'Tehran', 'state': 'Tehran Province', 'status': 'RECRUITING', 'country': 'Iran', 'contacts': [{'name': 'Golbon Sohrab, PhD', 'role': 'CONTACT', 'email': 'golbonsohrab@yahoo.com', 'phone': '9123069156'}], 'facility': 'NNFTRI clinic', 'geoPoint': {'lat': 35.69439, 'lon': 51.42151}}], 'centralContacts': [{'name': 'Golbon Sohrab', 'role': 'CONTACT', 'email': 'golbonsohrab@yahoo.com', 'phone': '+98-21-22077424'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Nutrition and Food Technology Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Dr Azita Hekmatdoost', 'investigatorAffiliation': 'National Nutrition and Food Technology Institute'}}}}