[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100592440":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":33,"centralContacts":38,"locations":44,"responsibleParty":60,"collaborators":24,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":66,"acronym":67,"eligibilityCriteria":68,"healthyVolunteers":69,"sex":70,"minAge":71,"maxAge":72,"enrollmentInfo":73,"targetDuration":24,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":24,"overallStatus":46,"whyStopped":24,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},{"fullName":5,"class":6},"AdventHealth Translational Research Institute","OTHER",[8,15],{"label":9,"type":6,"description":10,"interventionNames":11},"Lean, healthy controls","Control group.",[12,13,14],"Other: Magnetic Resonance Liver Assessment","Other: Bike Exercise VO2max","Other: DEXA",{"label":16,"type":6,"description":17,"interventionNames":18},"Individuals with T2D and hepatic steatosis","T2D group.",[12,13,14],[20,25,29],{"type":6,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"Magnetic Resonance Liver Assessment","Liver fat will be measured by MR imaging to assess level of hepatic steatosis.",[16,9],null,{"type":6,"name":26,"description":27,"armGroupLabels":28,"otherNames":24},"Bike Exercise VO2max","Maximal fitness measured by cycle ergometer.",[16,9],{"type":6,"name":30,"description":31,"armGroupLabels":32,"otherNames":24},"DEXA","Measure body composition (fat and lean body mass).",[16,9],[34],{"name":35,"affiliation":36,"role":37},"Justine Mucinski, PhD","AdventHealth","PRINCIPAL_INVESTIGATOR",[39],{"name":40,"role":41,"phone":42,"phoneExt":24,"email":43},"Recruitment Department","CONTACT","407-303-7100","CFD.TRI.Recruitment@AdventHealth.com",[45],{"facility":5,"status":46,"city":47,"state":48,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"RECRUITING","Orlando","Florida","32804","United States","US",{"type":53,"coordinates":54},"Point",[55,56],-81.37924,28.53834,{"lat":56,"lon":55},[59],{"name":40,"role":41,"phone":42,"phoneExt":24,"email":43},{"type":61,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR","100592440","acute-exercise-and-endogenous-glucose-production-in-type-2-diabetes-implications-for-glycemic-control-and-treatment-of-hepatic-steatosis-100592440",false,"NCT06993454","Acute Exercise and Endogenous Glucose Production in Type 2 Diabetes: Implications for Glycemic Control and Treatment of Hepatic Steatosis","ACELERATE-P","Inclusion criteria for individuals with T2D and elevated liver fat ≥5.6%\n\n1. Provision of signed and dated informed consent form\n2. Stated willingness to comply with all study procedures and availability for the duration of the study\n3. Male or (pre-menopausal) female, aged 25-55 years\n4. Body mass index (BMI) between 25 and 45 kg\u002Fm2\n5. Sedentary (1 day or less per week of structured exercise)\n6. Type 2 diabetes mellitus: HbA1c ≥7.5%\n7. Liver fat ≥5.6% based on MRI\n8. Weight stable (± 2 kg) for prior 3 months\n\nInclusion criteria for lean, healthy controls\n\n1. Provision of signed and dated informed consent form\n2. Stated willingness to comply with all study procedures and availability for the duration of the study\n3. Male or (pre-menopausal) female, aged 25-55 years\n4. Body mass index (BMI) between 18.5 and 27.5 kg\u002Fm2\n5. Normal liver fat (FibroScan CAP \\\u003C249dB\u002Fm, \\\u003C5.6% liver fat based on MRI)\n6. Weight stable (± 2 kg) for prior 3 months\n7. Active (≥3 day\u002Fweek of structured exercise)\n\nExclusion Criteria\n\n1. Exclusion criteria for individuals with T2D and elevated liver fat ≥5.6% Currently taking insulin, incretin mimetics, and\u002For thiazolidinediones\n2. Any change in glucose-lowering medications within the previous three months.\n3. Inability to stop any medications which interfere with glucose metabolism for visits 4 and 7.\n4. Resting blood pressure ≥ 160\u002F100 mm Hg\n5. Triglycerides ≥ 500 mg\u002FdL\n6. Any renal, cardiac, liver, lung, or neurological disease that in the opinion of the principal investigator would compromise participant safety or the participants' ability to complete the exercise protocol\n7. Any significant disease or unstable medical condition (i.e., coronary heart disease, chronic renal failure, chronic hepatic disease, severe pulmonary disease)\n8. Presence of clinically significant abnormalities on electrocardiogram (ECG) that is a contra-indication to exercise testing\n9. Cancer (active malignancy with or without concurrent chemotherapy; except for basal cell carcinoma)\n10. Pregnancy during the previous 6 months, lactating, or planned pregnancy in the next 6 months\n11. Post- or peri-menopausal women\n12. Partial and\u002For full hysterectomy (self-report)\n13. Use of drugs known to affect energy metabolism or body weight: including, but not limited to orlistat, sibutramine, ephedrine, phenylpropanolamine, corticosterone, etc\n14. Hyperthyroidism including those with normal TSH (0.35-4.5) on pharmacological treatment; individuals with hypothyroidism may be referred to their primary care provider for evaluation and retested; any medication change for hypothyroidism must be stable for ≥3 months prior to retesting\n15. Current treatment with blood thinners or anti-platelet medications that cannot be safely stopped for testing procedures\n16. New onset (\\\u003C3 months on a stable regime) hormone replacement therapy\n17. Current use of beta-adrenergic blocking agents\n18. Major surgery on the abdomen, pelvis, or lower extremities within previous 3 months\n19. Previous bariatric or other surgery for obesity\n20. Abnormal blood count\u002Fanemia (hemoglobin \\\u003C12 g\u002Fdl in men or 11 g\u002Fdl in women; Hct \\\u003C34%), blood transfusion or blood donation within the last 2 months\n21. Current smokers (smoking within the past 3 months prior to screening visit, including any\u002Fall tobacco products)\n22. Current drug or alcohol abuse\u002Fdependence, or positive urine toxicology screen\n23. Alcohol consumption \\>7 drinks per week for women or 14 drinks per week for men or history of binge drinking (≥5 drinks for males or 4 drinks for females in a 2-hour period more than once per month)\n24. Metal implants (pacemaker, aneurysm clips) based on investigator's judgment at screening\n25. Not physically capable of performing the exercise required of the study protocols\n26. Unable to participate in Magnetic Resonance Imaging (MRI) assessments due to physical limitations of equipment tolerances (e.g. MRI bore size) based on investigator's judgment at screening.\n27. Unable to tolerate MRI or claustrophobia.\n28. Diagnosed psychotic or psychiatric conditions prohibiting adherence to study protocol; hospitalization for any psychotic or psychiatric condition within one year\n29. Self-reported chronic, active, or latent infection requiring chronic antibiotic or anti-viral treatment; Human Immunodeficiency Virus (HIV); active hepatitis B or C undergoing antiviral therapy\n30. Unable or unwilling to communicate with staff or to provide written informed consent\n\nExclusion criteria for lean, healthy controls\n\n1. Currently taking insulin, injectable incretin mimetics, and\u002For thiazolidinediones\n2. Taking glucose-lowering medications\n3. HbA1c ≥ 5.7%; pre-diabetes, type 2 diabetes, or type 1 diabetes\n4. Resting blood pressure ≥ 160\u002F100 mm Hg\n5. Triglycerides ≥ 500 mg\u002FdL\n6. Any renal, cardiac, liver, lung, or neurological disease that in the opinion of the principal investigator would compromise participant safety or the participants' ability to complete the exercise protocol\n7. Any significant disease or unstable medical condition (i.e., coronary heart disease, chronic renal failure, chronic hepatic disease, severe pulmonary disease)\n8. Presence of clinically significant abnormalities on electrocardiogram (ECG) that is a contra-indication to exercise testing\n9. Cancer (active malignancy with or without concurrent chemotherapy; except for basal cell carcinoma)\n10. Pregnancy during the previous 6 months, lactating, or planned pregnancy in the next year\n11. Post- or peri-menopausal women\n12. Partial and\u002For full hysterectomy (self-report)\n13. Use of drugs known to affect energy metabolism or body weight: including, but not limited to orlistat, sibutramine, ephedrine, phenylpropanolamine, corticosterone, etc\n14. Hyperthyroidism including those with normal TSH (0.35-4.5) on pharmacological treatment; individuals with hypothyroidism may be referred to their primary care provider for evaluation and retested; any medication change for hypothyroidism must be stable for ≥3 months prior to retesting\n15. Current treatment with blood thinners or anti-platelet medications that cannot be safely stopped for testing procedures\n16. New onset (\\\u003C3 months on a stable regime) hormone replacement therapy\n17. Current use of beta-adrenergic blocking agents\n18. Major surgery on the abdomen, pelvis, or lower extremities within previous 3 months\n19. Previous bariatric or other surgery for obesity\n20. Increased liver function tests (AST\u002FALT\u002FGGT\u002For alkaline phosphatase greater than 2.5 times the upper limit of normal)\n21. Abnormal blood count\u002Fanemia (hemoglobin \\\u003C12 g\u002Fdl in men or 11 g\u002Fdl in women; Hct \\\u003C34%), blood transfusion or blood donation within the last 2 months\n22. Current smokers (smoking within the past 3 months prior to screening visit, including any\u002Fall tobacco products)\n23. Current drug or alcohol abuse\u002Fdependence, or positive urine toxicology screen\n24. Alcohol consumption \\>7 drinks per week for women or 14 drinks per week for men or history of binge drinking (≥5 drinks for males or 4 drinks for females in a 2-hour period more than once per month)\n25. Metal implants (pacemaker, aneurysm clips) based on investigator's judgment at screening\n26. Not physically capable of performing the exercise required of the study protocols\n27. Unable to participate in Magnetic Resonance Imaging (MRI) assessments due to physical limitations of equipment tolerances (e.g. MRI bore size) based on investigator's judgment at screening.\n28. Unable to tolerate MRI or claustrophobia.\n29. Diagnosed psychotic or psychiatric conditions prohibiting adherence to study protocol; hospitalization for any psychotic or psychiatric condition within one year\n30. Self-reported chronic, active, or latent infection requiring chronic antibiotic or anti-viral treatment; Human Immunodeficiency Virus (HIV); active hepatitis B or C undergoing antiviral therapy\n31. Unable or unwilling to communicate with staff or to provide written informed consent",true,"ALL","25 Years","55 Years",{"count":74,"type":75},12,"ESTIMATED","INTERVENTIONAL",[78],"NA","The overall aim of this study is to investigate the effects of exercise on the amount of glucose that is made by the liver in people with and without Type 2 diabetes (T2D) and hepatic steatosis (fatty liver).",[81,82],"Type 2 Diabetes","Hepatic Steatosis","2026-04-15",{"date":85,"type":86},"2026-04-17","ACTUAL",{"date":88,"type":86},"2025-04-25",{"date":90,"type":75},"2026-04",{"name":5,"class":6},1]