Ignite Creation Date:
2025-12-25 @ 3:56 AM
Ignite Modification Date:
2025-12-26 @ 2:47 AM
Study NCT ID:
NCT01065402
Status:
UNKNOWN
Last Update Posted:
2010-02-09
First Post:
2010-02-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Efficacy and Safety of PPB-R-203-Based Meal Versus TK9-Based Meal in 20 Patients With Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2010-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-02', 'completionDateStruct': {'date': '2010-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2010-02-08', 'studyFirstSubmitDate': '2010-02-05', 'studyFirstSubmitQcDate': '2010-02-08', 'lastUpdatePostDateStruct': {'date': '2010-02-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-02-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The daily blood glucose level will be monitored by the continuous glucose monitoring system (CGMS) device Medtronic MiniMed.', 'timeFrame': '2 days'}]}, 'conditionsModule': {'keywords': ['Diabetes mellitus', 'continuous glucose monitoring system (CGMS)'], 'conditions': ['Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': 'To evaluate the efficacy of PPB-R-203-Based Meal and TK9-Based Meal on blood glucose control in 20 patients with diabetes for 2 days.', 'detailedDescription': 'The MiniMed Medtronic CGMS (continuous glucose monitoring system), the first model approved by FDA, was used for subcutaneous glucose monitoring. The CGMS continually measures the glucose concentration of the interstitial fluid every 10 seconds and then stores an average glucose value for each 5 minutes period, for a total of up to 288 measurements each day.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Diabetes mellitus patient.\n2. Aged between 20 to 65 years old.\n3. Informed consent form signed.\n\nExclusion Criteria:\n\n1. A recent history of drug or alcohol abuse.\n2. Sensitivity to analogous product.\n3. Serious cardiovascular disorders.\n4. Participation in another clinical investigation study.\n5. Ongoing influenza, autoimmune disease and other metabolic diseases.\n6. Pregnant or lactating women.\n7. Individuals are judged by the investigators or co-investigator to be undesirable as subjects.'}, 'identificationModule': {'nctId': 'NCT01065402', 'briefTitle': 'A Study to Evaluate the Efficacy and Safety of PPB-R-203-Based Meal Versus TK9-Based Meal in 20 Patients With Diabetes', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pharma Power Biotec Co., Ltd.'}, 'officialTitle': 'A Randomized, Two-Regimen, Crossover, Comparative Study to Evaluate the Efficacy and Safety of PPB-R-203-Based Meal Versus TK9-Based Meal in 20 Patients With Diabetes', 'orgStudyIdInfo': {'id': 'PPB-R-203-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'TK9-Based Meal', 'description': 'TK9, Taikeng 9, is one commercially available rice manufacture by Yeedon Enterprise Co., Ltd. TK9-Based Meal is a diet equivalent to daily energy needs as judged by indirect calorimetry and of the same macronutrient composition.', 'interventionNames': ['Dietary Supplement: TK9-Based Meal']}, {'type': 'EXPERIMENTAL', 'label': 'PPB-R-203-Based Meal', 'description': 'PPB-R-203 is manufacture by Pharma Power Biotec Co., Ltd. The composition of PPB-R-203 is resistant starch (RS). By definition, resistant starch (RS) is any starch that is not digested in the small intestine but passes to the large intestine (or the colon). Therefore, resistant starch can be regarded as a component of dietary fiber. RS intake is associated with several changes in metabolism which may confer some health benefits.\n\nPPB-R-203-Based is the diet equivalent to daily energy needs as judged by indirect calorimetry and of the same macronutrient composition.', 'interventionNames': ['Dietary Supplement: PPB-R-203-Based Meal']}], 'interventions': [{'name': 'PPB-R-203-Based Meal', 'type': 'DIETARY_SUPPLEMENT', 'description': 'PPB-R-203 is manufacture by Pharma Power Biotec Co., Ltd. The composition of PPB-R-203 is resistant starch (RS). Resistant starch can be regarded as a component of dietary fiber. Some forms of RS are present naturally in many foods, and average global consumption is estimated at 3-10 g/day. PPB-R-203-Based is the diet equivalent to daily energy needs as judged by indirect calorimetry and of the same macronutrient composition.', 'armGroupLabels': ['PPB-R-203-Based Meal']}, {'name': 'TK9-Based Meal', 'type': 'DIETARY_SUPPLEMENT', 'description': 'TK9, Taikeng 9, is one commercially available rice manufacture by Yeedon Enterprise Co., Ltd. TK9-Based Meal is a diet equivalent to daily energy needs as judged by indirect calorimetry and of the same macronutrient composition.', 'armGroupLabels': ['TK9-Based Meal']}]}, 'contactsLocationsModule': {'locations': [{'zip': '900', 'city': 'Pingtung City', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Chang Daw Ming, Physician', 'role': 'CONTACT', 'email': 'dawming@gmail.com', 'phone': '886-8-7368686', 'phoneExt': '2714'}, {'name': 'Chuang Lee Ming, Physician', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'PingTung Christian Hospital', 'geoPoint': {'lat': 22.67135, 'lon': 120.48814}}], 'centralContacts': [{'name': 'Hsieh Mei Huei', 'role': 'CONTACT', 'email': 'judyie@isredbioresearch.com.tw', 'phone': '886-8-762-8188'}], 'overallOfficials': [{'name': 'Chuang Lee Ming, Physician', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Taiwan University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pharma Power Biotec Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'isRed Pharma & Biotech Research Corporation', 'oldOrganization': 'Isredbioresearch'}}}}