Ignite Creation Date:
2025-12-25 @ 4:26 AM
Ignite Modification Date:
2026-03-15 @ 1:00 PM
Study NCT ID:
NCT04375020
Status:
COMPLETED
Last Update Posted:
2020-05-07
First Post:
2020-05-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
GABA and Beta-cell Regeneration
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}], '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'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005680', 'term': 'gamma-Aminobutyric Acid'}], 'ancestors': [{'id': 'D000613', 'term': 'Aminobutyrates'}, {'id': 'D002087', 'term': 'Butyrates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}, 'targetDuration': '6 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2020-05-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-05-05', 'studyFirstSubmitDate': '2020-05-02', 'studyFirstSubmitQcDate': '2020-05-02', 'lastUpdatePostDateStruct': {'date': '2020-05-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-05-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'gaba decrease anti gad antibodies', 'timeFrame': '6 months', 'description': 'gaba 750 mg daily for type 1 diabetes patients'}, {'measure': 'gaba improve c peptide levels', 'timeFrame': '6 months', 'description': 'gaba 750 mg pe day for type 1 diabetes patients'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['type 1diabetes, gaba'], 'conditions': ['Diabetes Mellitus, Type 1']}, 'descriptionModule': {'briefSummary': 'GABA(gamma-Aminobutyric acid) may be used for decreasing anti-gad antibodies and leads beta-cell regeneration.', 'detailedDescription': '100 patients with type I diabetes were in 2 groups, had been monitored in a private clinic, number 50 each group, with 30 females and 20 males after the written consent of all patients.\n\nAll the patients Lied between 18-25 years old with 5-10 years of diabetes onset.\n\nThe first group was on insulin therapy in the form of toujeo once daily and Novorapid 3 times daily and they received GABA nutritional supplement 750mg per day.\n\nThe second group was only on insulin injection in the form of toujeo once daily and Novorapid 3 times daily.\n\nIn the first group;the investigator measured fasting c peptide levels before and after 6 months of GABA 750mg daily.Also,the investigator measured anti gad antibodies before and after 6 months of treatment.\n\nIn the second group,the investigator measured c peptide levels and anti-gad antibodies at the beginning of the trial and after 6 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '25 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'observation prospective study 100 patients with type I diabetes were int 2 groups, had been monitored in a private clinic, number 50 each group, with 30 females and 20 males after the written consent of all patients.\n\nAll the patients Lied between 18-25 years old with 5-10 years of diabetes onset.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- type 1 diabetes patients age from 18 to 25 years on basal bolus insulin\n\nExclusion Criteria:\n\nthyroid problems liver disease kidney disease'}, 'identificationModule': {'nctId': 'NCT04375020', 'briefTitle': 'GABA and Beta-cell Regeneration', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Ministry of Health and Population, Egypt'}, 'officialTitle': 'GABA From Medical Nutrition to Pancreatic Beta-cell Regeneration', 'orgStudyIdInfo': {'id': 'icel'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'group1 on GABA', 'description': 'The first group was on insulin therapy in the form of toujeo once daily and Novorapid 3 times daily and they received GABA nutritional supplement 750mg per day.', 'interventionNames': ['Drug: GABA']}, {'label': 'group 2 on just insulin', 'description': 'The second group was only on insulin injection in the form of toujeo once daily and Novorapid 3 times daily.'}], 'interventions': [{'name': 'GABA', 'type': 'DRUG', 'description': 'GABA nutritional supplement 750mg per day for 6 months', 'armGroupLabels': ['group1 on GABA']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11865', 'city': 'Cairo', 'country': 'Egypt', 'facility': 'Mahmoud Younis', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ministry of Health and Population, Egypt', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'consultant', 'investigatorFullName': 'mahmoud younis', 'investigatorAffiliation': 'Ministry of Health and Population, Egypt'}}}}