[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100462716":3},{"organization":4,"armGroups":7,"interventions":28,"overallOfficials":41,"centralContacts":45,"locations":54,"responsibleParty":81,"collaborators":84,"id":88,"slug":89,"hasResults":90,"nctId":91,"briefTitle":92,"officialTitle":93,"acronym":40,"eligibilityCriteria":94,"healthyVolunteers":90,"sex":95,"minAge":96,"maxAge":97,"enrollmentInfo":98,"targetDuration":40,"studyType":101,"phases":102,"briefSummary":104,"conditions":105,"keywords":109,"overallStatus":57,"whyStopped":40,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":114,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":122},{"fullName":5,"class":6},"The University of Texas Health Science Center at San Antonio","OTHER",[8,14,20,24],{"label":9,"type":10,"description":11,"interventionNames":12},"NAFL TZD","EXPERIMENTAL","T2D with non-alcoholic fatty liver (NAFL), treated with pioglitazone",[13],"Drug: Pioglitazone",{"label":15,"type":16,"description":17,"interventionNames":18},"NAFL Placebo","PLACEBO_COMPARATOR","T2D with non-alcoholic fatty liver (NAFL), treated with placebo",[19],"Other: Placebo",{"label":21,"type":10,"description":22,"interventionNames":23},"NASH TZD","T2D with non-alcoholic steatohepatitis (NASH), treated with pioglitazone",[13],{"label":25,"type":16,"description":26,"interventionNames":27},"NASH Placebo","T2D with non-alcoholic steatohepatitis (NASH), treated with placebo",[19],[29,36],{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"DRUG","Pioglitazone","An insulin sensitizer and anti-diabetic agent. Participants will be started on 15 mg\u002Fday, increased to 30 mg\u002Fday at week 2 and then to 45 mg\u002Fday at week 4.",[9,21],[35],"Actos",{"type":6,"name":37,"description":38,"armGroupLabels":39,"otherNames":40},"Placebo","Placebo for pioglitazone",[15,25],null,[42],{"name":43,"affiliation":5,"role":44},"Luke Norton, PhD","PRINCIPAL_INVESTIGATOR",[46,50],{"name":43,"role":47,"phone":48,"phoneExt":40,"email":49},"CONTACT","210-567-0739","nortonl@uthscsa.edu",{"name":51,"role":47,"phone":52,"phoneExt":40,"email":53},"Andrea Hansis-Diarte, MPH","210-567-3208","hansisdiarte@uthscs.edu",[55,75],{"facility":56,"status":57,"city":58,"state":59,"zip":60,"country":61,"countryCode":62,"cosmosGeoPoint":63,"geoPoint":68,"contacts":69},"Texas Diabetes Institute - University Health System","RECRUITING","San Antonio","Texas","78207","United States","US",{"type":64,"coordinates":65},"Point",[66,67],-98.49363,29.42412,{"lat":67,"lon":66},[70,74],{"name":71,"role":47,"phone":72,"phoneExt":40,"email":73},"Andrea Hansis-Diarte, MPh","210-567-6691","hansisdiarte@uthscsa.edu",{"name":43,"role":47,"phone":48,"phoneExt":40,"email":73},{"facility":76,"status":57,"city":58,"state":59,"zip":77,"country":61,"countryCode":62,"cosmosGeoPoint":78,"geoPoint":80,"contacts":40},"University of Texas Health Science Center at San Antonio","78229",{"type":64,"coordinates":79},[66,67],{"lat":67,"lon":66},{"type":44,"investigatorFullName":82,"investigatorTitle":83,"investigatorAffiliation":5,"oldNameTitle":40,"oldOrganization":40},"Luke Norton","Assistant Professor",[85],{"name":86,"class":87},"National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)","NIH","100462716","phase-4-quantifying-hepatic-mitochondrial-fluxes-in-humans-100462716",false,"NCT05305287","Quantifying Hepatic Mitochondrial Fluxes in Humans","Quantitation of Hepatic Mitochondrial Fluxes in Humans With Nonalcoholic Fatty Liver Disease (NAFLD)","T2D with NAFL\n\nInclusion Criteria:\n\n* Confirmed T2D based on OGTT (2 h glucose ≥200 mg\u002Fdl).\n* Treated with diet, metformin, and\u002For sulfonylurea and in good general health determined by medical history, physical exam, and routine blood chemistries;\n* age = 18-80 years;\n* BMI = 25-40 kg\u002Fm2;\n* HbA1c = 7-10%; stable body weight (±4 pounds) over the preceding 3-months;\n* not taking any medication known to affect glucose metabolism other than antidiabetic medications.\n* Evidence of moderate\u002Fsevere fatty liver (steatosis; grade S2\u002FS3 on FibroScan corresponding to ≥10% fat on MRI-PDFF) and no\u002Fminimal hepatic fibrosis (grade F0\u002FF1 on FibroScan).\n\nExclusion Criteria:\n\n* Alcohol consumption \\>14 units\u002Fweek for women and \\>21 units\u002Fweek for men.\n* Cirrhosis (fibrosis stage 4).\n* Type 1 diabetes and\u002For GAD positive subjects.\n* Subjects not drug naive or have been on metformin more than 3 months.\n* Presence of proliferative retinopathy.\n* Urine albumin excretion \\> 300 mg\u002Fday.\n* Evidence of other forms of chronic liver disease, including alcoholic liver disease, hepatitis B and C, primary biliary cholangitis, suspected\u002Fproven liver cancer and any other liver disease other than NAFLD.\n* History of NY Class III-IV heart failure\n\nT2D with NASH\n\nInclusion Criteria:\n\n* Confirmed T2D based on OGTT (2 h glucose ≥200 mg\u002Fdl).\n* Treated with diet, metformin, and\u002For sulfonylurea and in good general health determined by medical history, physical exam, and routine blood chemistries;\n* age = 18-80 years;\n* BMI = 25-40 kg\u002Fm2;\n* HbA1c = 7-10%;\n* stable body weight (±4 pounds) over the preceding 3-months;\n* not taking any medication known to affect glucose metabolism other than antidiabetic medications.\n* Evidence of moderate\u002Fsevere fatty liver (steatosis; grade S2\u002FS3 on FibroScan corresponding to ≥10% liver fat on MRI-PDFF) and moderate\u002Fsevere hepatic fibrosis (grade F2\u002FF3 on FibroScan).\n\nExclusion Criteria:\n\n* Alcohol consumption \\>14 units\u002Fweek for women and \\>21 units\u002Fweek for men.\n* Cirrhosis (fibrosis stage 4).\n* Type 1 diabetes and\u002For GAD positive subjects.\n* Subjects not drug naive or have been on metformin more than 3 months.\n* Presence of proliferative retinopathy.\n* Urine albumin excretion \\> 300 mg\u002Fday.\n* Evidence of other forms of chronic liver disease, including alcoholic liver disease, hepatitis B and C, primary biliary cholangitis, suspected\u002Fproven liver cancer and any other liver disease other than NAFLD.\n* History of NY Class III-IV heart failure","ALL","18 Years","80 Years",{"count":99,"type":100},60,"ESTIMATED","INTERVENTIONAL",[103],"PHASE4","In this study the investigators will quantitate hepatic mitochondrial fluxes in T2D patients with NAFL and NASH before and after 16-weeks treatment with the insulin sensitizer pioglitazone",[106,107,108],"Non-Alcoholic Fatty Liver Disease","Type 2 Diabetes","Mitochondrial Metabolism Disorders",[110,111,112],"NAFLD","Diet","Exercise","2026-01-07",{"date":115,"type":116},"2026-01-09","ACTUAL",{"date":118,"type":116},"2022-11-01",{"date":120,"type":100},"2027-03-31",{"name":5,"class":6},2]