Ignite Creation Date:
2025-12-25 @ 12:43 AM
Ignite Modification Date:
2025-12-25 @ 10:56 PM
Study NCT ID:
NCT03452267
Status:
WITHDRAWN
Last Update Posted:
2020-10-08
First Post:
2018-02-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Insulin Signaling in Skeletal Muscle
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007333', 'term': 'Insulin Resistance'}], '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': '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': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Lack of funding', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2019-09-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2025-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-10-05', 'studyFirstSubmitDate': '2018-02-12', 'studyFirstSubmitQcDate': '2018-02-28', 'lastUpdatePostDateStruct': {'date': '2020-10-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-03-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proteomic', 'timeFrame': '3 months', 'description': 'Changes in global protein abundance levels'}, {'measure': 'Proteomic 2', 'timeFrame': '3 months', 'description': 'Changes in global protein phosphorylation levels'}], 'secondaryOutcomes': [{'measure': 'Epigenomic', 'timeFrame': '3 months', 'description': 'Change in global DNA percent methylation'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Insulin Sensitivity']}, 'descriptionModule': {'briefSummary': 'The insulin sensitizing effects of metformin and pioglitazone in the skeletal muscle remain unknown. Our group aims to analyze molecular changes within the skeletal muscle of pre-diabetic patients through the use of a clinical trial in humans.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pre-diabetes as defined by an oral glucose tolerance test 2-hour level between 140 and 200 mg/dL\n\nGeneral Inclusion Criteria:\n\n* Able to communicate meaningfully with the investigator and legally competent to provide informed written consent.\n* Female subjects must be non-lactating, have a negative pregnancy test, and be on acceptable birth control.\n\nExclusion Criteria:\n\n* Oral glucose tolerance test \\<140 or \\>200mg/dL\n* Treated with any of the following medications:\n\n * Systemic glucocorticoids (more than 2 weeks), antineoplastic agents, transplant medications, fibrates, anti-retroviral medications, or thiazolidinediones within 6 months prior to screening\n * Start or change of hormonal replacement therapy within 3 months prior to screening\n * Short-acting insulin (more than15 units per day) in DMT2 subjects, indicating severe insulin deficiency within 6 months prior to screening\n* History or presence of any of the following conditions:\n\n * Clinically significant heart disease (New York Heart Classification greater than grade II; more than non-specific ST-T wave changes on the EKG)\n * Peripheral vascular disease (history of claudication)\n * Clinically significant pulmonary disease.\n * Current uncontrolled hypertension (systolic BP\\>160 mmHg, diastolic BP\\>100 mmHg)\n * History or presence of malignancy other than basal cell or squamous cell skin cancer\n * Autonomic neuropathy\n * Clinically significant hematologic disease\n* Any of the following abnormal laboratory values:\n\n * Hematocrit \\< 35 vol%\n * Serum creatinine \\> 1.6 mg/dl\n * AST, ALT or Alkaline phosphatase \\> 2.5 times the upper limit of normal\n * PT, PTT outside the normal reference range\n * TSH outside the normal reference range\n * Triglycerides \\> 400 mg/dl\n * Platelet count \\< 50,000\n* Current or history of drug abuse or alcohol abuse\n* Blood donation within 2 months prior to screening\n* Engage in exercise with moderate to hard intensity for greater than 1 hour per day for 5 or more days per week.\n* Diagnosed with Type 1 diabetes'}, 'identificationModule': {'nctId': 'NCT03452267', 'briefTitle': 'Insulin Signaling in Skeletal Muscle', 'organization': {'class': 'OTHER', 'fullName': 'Wayne State University'}, 'officialTitle': 'Effect of Metformin and Pioglitazone on Insulin Signaling in Skeletal Muscle', 'orgStudyIdInfo': {'id': 'MetPioMuscle'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Metformin', 'interventionNames': ['Drug: Metformin']}, {'type': 'EXPERIMENTAL', 'label': 'Pioglitazone', 'interventionNames': ['Drug: Pioglitazone']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Metformin', 'type': 'DRUG', 'description': 'oral, 850 mg twice daily', 'armGroupLabels': ['Metformin']}, {'name': 'Pioglitazone', 'type': 'DRUG', 'description': 'oral, 45 mg daily', 'armGroupLabels': ['Pioglitazone']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'oral, once daily', 'armGroupLabels': ['Placebo']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wayne State University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Pharmacy Practice', 'investigatorFullName': 'Kyle Jon Burghardt, Pharm.D.', 'investigatorAffiliation': 'Wayne State University'}}}}