Ignite Creation Date:
2025-12-25 @ 2:30 AM
Ignite Modification Date:
2025-12-30 @ 4:16 AM
Study NCT ID:
NCT06970834
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-05-14
First Post:
2025-04-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Explore the Effect of Bitter Melon Peptides on Glycemic Control and Metabolic Indicators in Diabetic Patients
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': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'A total of 160 diabetic patients on Metformin monotherapy will be recruited and randomized into either the bitter melon peptide group or the placebo group for a 12-week clinical intervention'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 160}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-05-27', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2026-03-26', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-06', 'studyFirstSubmitDate': '2025-04-24', 'studyFirstSubmitQcDate': '2025-05-06', 'lastUpdatePostDateStruct': {'date': '2025-05-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'metabolic indicator', 'timeFrame': 'From enrollment (day0) to the end (day84)', 'description': 'C-peptide'}], 'primaryOutcomes': [{'measure': 'glycemic variability', 'timeFrame': 'From enrollment (day0) to day7', 'description': 'mean amplitude of glucose excursions and coefficient of variation, using CGM'}], 'secondaryOutcomes': [{'measure': 'glycemic control', 'timeFrame': 'From enrollment (day0) to the end (day84)', 'description': 'Glycated hemoglobulin A1C'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['bitter melon peptides'], 'conditions': ['Diabetes']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to learn the potential of bitter melon peptides in stabilizing blood glucose in diabetic adults. It will also learn about the effects of bitter melon peptides on metabolic parameters. The main questions it aims to answer are:\n\n* the regulatory effects of bitter melon peptides on glycemic variability\n* impact on glycemic and metabolic indicators Researchers will compare bitter melon peptides to a placebo (a look-alike capsule that contains Microcrystalline Cellulose) to see if bitter melon peptides works to stabilizing blood glucose.\n\nParticipants will:\n\n* Take bitter melon peptides or a placebo every day for 12 weeks\n* Visit the clinic on day 0, day 7, day 28 and day 84 for checkups and tests\n* Glucose levels were monitored continuously by CGMs in the first 7 days and fasting blood samples were drawn at first visit (day0), third visit (day 28) and fourth visits (day 84)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:Participants were diagnosed with type 2 DM based on criteria recommended by the American Diabetes Association and required to have fasting plasma glucose of ≥126 mg/dl or an HbA1c of\n\n≥ 6.5%, as measured on two separate occasions\n\nExclusion Criteria:cancer, active liver disease, current pregnancy , acute illness and autoimmune thyroid disease.'}, 'identificationModule': {'nctId': 'NCT06970834', 'briefTitle': 'Explore the Effect of Bitter Melon Peptides on Glycemic Control and Metabolic Indicators in Diabetic Patients', 'organization': {'class': 'OTHER', 'fullName': 'Changhua Christian Hospital'}, 'officialTitle': 'Using Continuous Glucose Monitoring Tools to Explore the Effect of Bitter Melon Peptides on Glycemic Control and Metabolic Indicators in Diabetic Patients', 'orgStudyIdInfo': {'id': 'CCH IRB 250121'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'bitter melon peptides', 'description': 'Bitter melon peptide contains various active substances such as bitter melon saponins and bitter melon polysaccharides.', 'interventionNames': ['Dietary Supplement: bitter melon peptides']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo group', 'description': 'The placebo capsule containing microcrystalline cellulose. The placebo is identical in appearance, color, and dosage schedule to the intervention product, but does not contain any active ingredients.', 'interventionNames': ['Dietary Supplement: bitter melon peptides']}], 'interventions': [{'name': 'bitter melon peptides', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Momordica charantia extract', 'armGroupLabels': ['Placebo group', 'bitter melon peptides']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'PEI-YUNG LIAO, M.D.', 'role': 'CONTACT', 'email': '48795@cch.org.tw', 'phone': '+88647238595'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Changhua Christian Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'China Medical University, Taiwan', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief of Division of Endocrinology and Metabolism, Department of Internal Medicine', 'investigatorFullName': 'PEI-YUNG LIAO', 'investigatorAffiliation': 'Changhua Christian Hospital'}}}}