Ignite Creation Date:
2025-12-24 @ 7:16 PM
Ignite Modification Date:
2026-02-19 @ 5:54 AM
Study NCT ID:
NCT02027103
Status:
COMPLETED
Last Update Posted:
2014-01-03
First Post:
2014-01-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Metformin and Pioglitazone Effects on Fetuin-A and Osteoprotegrin Concentrations in Type 2 Diabetes Patients
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': 'D008687', 'term': 'Metformin'}, {'id': 'D000077205', 'term': 'Pioglitazone'}], 'ancestors': [{'id': 'D001645', 'term': 'Biguanides'}, {'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D045162', 'term': 'Thiazolidinediones'}, {'id': 'D013844', 'term': 'Thiazoles'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 102}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-01', 'completionDateStruct': {'date': '2012-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-01-02', 'studyFirstSubmitDate': '2014-01-02', 'studyFirstSubmitQcDate': '2014-01-02', 'lastUpdatePostDateStruct': {'date': '2014-01-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-01-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Serum concentrations of fetuin-A', 'timeFrame': '12 weeks'}, {'measure': 'Serum concentrations of osteoprotegrin', 'timeFrame': '12 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Fetuin-A', 'OPG', 'Metformin', 'Pioglitazone'], 'conditions': ['Type 2 Diabetes Mellitus']}, 'referencesModule': {'references': [{'pmid': '25450818', 'type': 'DERIVED', 'citation': 'Esteghamati A, Afarideh M, Feyzi S, Noshad S, Nakhjavani M. Comparative effects of metformin and pioglitazone on fetuin-A and osteoprotegerin concentrations in patients with newly diagnosed diabetes: A randomized clinical trial. Diabetes Metab Syndr. 2015 Oct-Dec;9(4):258-65. doi: 10.1016/j.dsx.2014.09.009. Epub 2014 Oct 14.'}]}, 'descriptionModule': {'briefSummary': 'Oral hypoglycemic agents, along with dietary modification and exercise encompass the mainstay of treatment in early stages of T2DM. Biguanides and thiazolidinediones are two major groups of hypoglycemic medications that while function via different pathways, mare both effective in short- and long-term glucose control. These medications diminish or delay long term micro- and macrovascular complications associated with T2DM although at different rates. Excessive insulin resistance accounts for a sustained increase in cardiovascular incidents in T2DM subjects. Given the shared pathway of insulin resistance/fetuin-A/OPG in atherosclerosis formation, it is conceivable that insulin sensitizing anti-diabetes medications are able to modify successive CAD risk via direct and indirect amelioration of insulin resistance/fetuin-A/OPG. The present study is therefore designed to investigate the effects of metformin and pioglitazone monotherapy on serum concentrations of fetuin-A and OPG in a group of Iranian adults with newly diagnosed T2DM.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '35 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nNewly diagnosed type 2 diabetes patients based on American Diabetes Association criteria (2011) for diagnosis of diabetes\n\nExclusion Criteria:\n\nPrevious intake of oral hypoglycemic agents for treatment of diabetes or other hyperglycemia associated conditions Intake of glucocorticoids in the past one year Major illnesses of heart, lung, kidney, and liver.'}, 'identificationModule': {'nctId': 'NCT02027103', 'briefTitle': 'Metformin and Pioglitazone Effects on Fetuin-A and Osteoprotegrin Concentrations in Type 2 Diabetes Patients', 'organization': {'class': 'OTHER', 'fullName': 'Tehran University of Medical Sciences'}, 'officialTitle': 'Comparative Effects of Metformin and Pioglitazone on Fetuin-A and Osteoprotegerin Concentrations in Patients With Newly Diagnosed Diabetes: A Randomized Clinical Trial', 'orgStudyIdInfo': {'id': '90-111-60037'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Metformin', 'description': 'patients receiving fixed dose metformin 1000 mg daily', 'interventionNames': ['Drug: Metformin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Pioglitazone', 'description': 'patients receiving fixed dose pioglitazone 30 mg daily', 'interventionNames': ['Drug: Pioglitazone']}], 'interventions': [{'name': 'Metformin', 'type': 'DRUG', 'description': 'Metformin 1000 mg fixed dose, twice daily (500 mg tablets x 2)', 'armGroupLabels': ['Metformin']}, {'name': 'Pioglitazone', 'type': 'DRUG', 'description': 'Pioglitazone 30 mg fixed dose, twice daily (15 mg tablets x 2)', 'armGroupLabels': ['Pioglitazone']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13145-784', 'city': 'Tehran', 'country': 'Iran', 'facility': 'Diabetes Clinic, Vali-Asr Hospital, Tehran University of Medical Sciences', 'geoPoint': {'lat': 35.69439, 'lon': 51.42151}}], 'overallOfficials': [{'name': 'Alireza Esteghamati, M.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tehran University of Medical Sciences'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tehran University of Medical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Alireza Esteghamati, M.D.', 'investigatorFullName': 'Alireza Esteghamati', 'investigatorAffiliation': 'Tehran University of Medical Sciences'}}}}