Ignite Creation Date:
2025-12-24 @ 4:36 PM
Ignite Modification Date:
2026-01-16 @ 5:19 AM
Study NCT ID:
NCT02775266
Status:
COMPLETED
Last Update Posted:
2017-03-13
First Post:
2016-05-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Antioxidant Intake on Resistin Levels In Patients With Gum Disease and Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D010518', 'term': 'Periodontitis'}], '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'}, {'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008063', 'term': 'Thioctic Acid'}, {'id': 'D014080', 'term': 'Tooth Exfoliation'}, {'id': 'D016745', 'term': 'Root Planing'}], 'ancestors': [{'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013876', 'term': 'Thiophenes'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D003067', 'term': 'Coenzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D009063', 'term': 'Dental Physiological Phenomena'}, {'id': 'D055688', 'term': 'Digestive System and Oral Physiological Phenomena'}, {'id': 'D012534', 'term': 'Dental Scaling'}, {'id': 'D003777', 'term': 'Dental Prophylaxis'}, {'id': 'D010517', 'term': 'Periodontics'}, {'id': 'D003813', 'term': 'Dentistry'}, {'id': 'D013357', 'term': 'Subgingival Curettage'}, {'id': 'D011313', 'term': 'Preventive Dentistry'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-10', 'studyFirstSubmitDate': '2016-05-05', 'studyFirstSubmitQcDate': '2016-05-12', 'lastUpdatePostDateStruct': {'date': '2017-03-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-05-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Serum Resistin Levels and HBAIC Levels', 'timeFrame': '3 months', 'description': '2ml of blood sample will be collected by venepuncture at baseline and after 3 months and will be assessed by ELISA stored in EDTA containing vials to identify the levels of resistin in the patients by ELISA.\n\nGlycosylated hemoglobin levels (Hb1aC) will be recorded at baseline and after 3 months and assessed by Spectrophotometer.'}], 'secondaryOutcomes': [{'measure': 'Gingival Index', 'timeFrame': '3 months', 'description': "Gingival index was recorded with william's periodontal probe at baseline and after 3 months"}, {'measure': 'Probing pocket depth', 'timeFrame': '3 months', 'description': "Were recorded with william's periodontal probe at baseline and after 3 months"}, {'measure': 'Clinical Attachment levels', 'timeFrame': '3 Months', 'description': "Were recorded with william's periodontal probe at baseline and after 3 months"}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Diabetes Mellitus', 'Periodontitis']}, 'referencesModule': {'references': [{'pmid': '16881798', 'type': 'BACKGROUND', 'citation': 'Mealey BL, Oates TW; American Academy of Periodontology. Diabetes mellitus and periodontal diseases. J Periodontol. 2006 Aug;77(8):1289-303. doi: 10.1902/jop.2006.050459.'}, {'pmid': '20142950', 'type': 'BACKGROUND', 'citation': 'Pendyala G, Thomas B, Kumari S. The challenge of antioxidants to free radicals in periodontitis. J Indian Soc Periodontol. 2008 Sep;12(3):79-83. doi: 10.4103/0972-124X.44100.'}]}, 'descriptionModule': {'briefSummary': 'To evaluate the effectiveness of non surgical periodontal therapy in addition to antioxidant(ALA) on resistin levels in patients with type 2 diabetes and periodontal disease', 'detailedDescription': 'A total of 40 patients with diabetes and chronic periodontitis attending the department of periodontics will be recruited in the study. 40 subjects will be randomly divided into two groups(control group and test group with 20 subjects in each group). Clinical parameters such as gingival index, periodontal index, random blood sugar levels(RBS) and glycosylated hemoglobin levels (Hb1aC) will be recorded at baseline and after 3 months and 2ml of blood sample will be collected by venepuncture ( baseline and after 3 months) and stored in Ethylenediaminetetraacetic acid containing vials to identify the levels of resistin in the patients by Enzyme linked immunosorbent assay. Group A will receive Alpha lipoic acid at baseline for a period of 3 months. Both the groups will receive scaling and rootplaning at baseline.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '35 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria: Diabetic patients with Chronic periodontitis.\n\n\\-\n\nExclusion Criteria: Smokers, Pregnant \\& lactating women, Prior periodontal therapy within 3 months.'}, 'identificationModule': {'nctId': 'NCT02775266', 'acronym': 'EARGD', 'briefTitle': 'Effect of Antioxidant Intake on Resistin Levels In Patients With Gum Disease and Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre'}, 'officialTitle': 'Effect of Systemic Administration of ALA (Alpha Lipoic Acid) as an Adjunct to Scaling and Rootplaning on Serum Resistin Levels in Patients With Chronic Periodontitis and Type 2 Diabetes Mellitus', 'orgStudyIdInfo': {'id': '00159'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'ALA + Scaling and Root planing', 'description': 'Systemic antioxidant Alpha lipoic acid 1800mg/day in 3 divided doses for a period of 3 months(group B)', 'interventionNames': ['Other: Alpha lipoic acid', 'Procedure: Scaling and Root planing']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Scaling and root planing only', 'description': 'Patients will receive scaling and root planning at baseline and 3 months(group A)', 'interventionNames': ['Procedure: Scaling and Root planing']}], 'interventions': [{'name': 'Alpha lipoic acid', 'type': 'OTHER', 'description': 'Scaling and root planing will be done at baseline and systemic antioxidant Alpha lipoic acid 1800mg/day in 3 divided doses for a period of 3 months.', 'armGroupLabels': ['ALA + Scaling and Root planing']}, {'name': 'Scaling and Root planing', 'type': 'PROCEDURE', 'description': 'Scaling and root planing will be done at baseline.', 'armGroupLabels': ['ALA + Scaling and Root planing', 'Scaling and root planing only']}]}, 'contactsLocationsModule': {'locations': [{'zip': '500029', 'city': 'Hyderabad', 'state': 'Telangana', 'country': 'India', 'facility': 'Mohans Diabetic Centre', 'geoPoint': {'lat': 17.38405, 'lon': 78.45636}}], 'overallOfficials': [{'name': 'Kinnera Surapaneni, [MDS]', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'PANINEEYA INSTITUTE OF DENTAL SCIENCES ROAD NO: 5, KAMALANAGAR DILSUKHNAGAR, HYDERABAD - 500060'}, {'name': 'Rekha R Koduganti, MDS Perio', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Professor&HOD Dept.of.Periodontics,PMVIDS'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PG student', 'investigatorFullName': 'kinnera surapaneni', 'investigatorAffiliation': 'Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre'}}}}