Ignite Creation Date:
2025-12-24 @ 6:33 PM
Ignite Modification Date:
2026-01-31 @ 7:25 PM
Study NCT ID:
NCT00614757
Status:
SUSPENDED
Last Update Posted:
2012-10-26
First Post:
2008-01-31
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Insulin Resistance Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D024821', 'term': 'Metabolic Syndrome'}], 'ancestors': [{'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000111', 'term': 'Acetylcysteine'}], 'ancestors': [{'id': 'D003545', 'term': 'Cysteine'}, {'id': 'D000603', 'term': 'Amino Acids, Sulfur'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 121}}, 'statusModule': {'overallStatus': 'SUSPENDED', 'startDateStruct': {'date': '2005-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-10', 'completionDateStruct': {'date': '2013-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-10-25', 'studyFirstSubmitDate': '2008-01-31', 'studyFirstSubmitQcDate': '2008-01-31', 'lastUpdatePostDateStruct': {'date': '2012-10-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-02-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Those patients who are identified to have insulin resistance will be asked to participate in the treatment phase of the study', 'timeFrame': '2 years'}], 'secondaryOutcomes': [{'measure': 'One half of patients with insulin resistance will undergo 30 day treatment with N-acetylcysteine to see if we can measure an improvement in fasting insulin and glucose levels', 'timeFrame': '2 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Insulin Resistance', 'Metabolic Syndrome x']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate how often patients with hepatitis C infection have abnormalities of sugar and fat utilization. Additionally we would like to find out if these abnormalities of sugar and fat utilization are common in other liver diseases, or related to being overweight.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ability to give written consent\n* HCV RNA PCR positive for 6 months\n* Normal Hgb, WBC,Neutrophils\n* Platelets of \\>/= 65,000\n* Direct Bili, within 20% ULN\n* Albumin \\>3\n* Serum Creatinine \\<20% ULN\n* TSH WNL\n* AFP \\</= 100\n\nExclusion Criteria:\n\n* Women who are pregnant or breast-feeding\n* No Thiazolidinedione, Metformin,unless required for the treatment of type II DM\n* Hepatitis C of non-genotype 1,2,3\n* Any other cause for liver disease other than chronic hepatitis C\n* Hemoglobinopathies\n* Evidence of advanced liver disease\n* Previous organ transplant\n* Severe psychiatric disorder\n* Significant cardiovascular dysfunction within the past 12 months\n* Poorly controlled diabetes mellitus\n* Immunologically mediated disease\n* Any medical condition requiring chronic systemic administration of steroids\n* Evidence of an active or suspected cancer\n* Substance abuse at the time of the study\n* Known HIV\n* Irritability or unwillingness to provide informed consent'}, 'identificationModule': {'nctId': 'NCT00614757', 'acronym': 'IR', 'briefTitle': 'Insulin Resistance Study', 'organization': {'class': 'OTHER', 'fullName': "Midwest Veterans' Biomedical Research Foundation"}, 'officialTitle': 'The Prevalence of Insulin Resistance and the Potential Modulation of Insulin Resistance by N-acetylcysteine (NAC) in Patients Chronically Infected by the Hepatitis C Virus', 'orgStudyIdInfo': {'id': 'PKP0003'}, 'secondaryIdInfos': [{'id': '00173'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': '2', 'description': 'One half of the patients will take not medication for 30 days and then have labs redrawn'}, {'type': 'EXPERIMENTAL', 'label': '1', 'description': 'one half of the patients with insulin resistance will take 4ml of 20% N-acetylcysteine BID for 30 days', 'interventionNames': ['Drug: N-acetylcysteine 20% 4ml', 'Drug: N-acetylcysteine 20% in 4 ml']}], 'interventions': [{'name': 'N-acetylcysteine 20% 4ml', 'type': 'DRUG', 'description': 'N-acetylcysteine 20% 4ml', 'armGroupLabels': ['1']}, {'name': 'N-acetylcysteine 20% in 4 ml', 'type': 'DRUG', 'description': 'N-acetylcysteine 20% in 4 ml', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '64128', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': 'Kansas City VA Medical Center', 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}], 'overallOfficials': [{'name': 'Prashant K Pandya, DO', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kansas City VA Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Midwest Biomedical Research Foundation', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Prashant Pandya', 'investigatorAffiliation': 'Kansas City Veteran Affairs Medical Center'}}}}