[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Medanta, The Medicity, India\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":86},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,42,64],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100520732","effect-of-oral-semaglutide-on-liver-fat-and-body-composition-in-liver-transplant-recipients-with-diabetes-mellitus-100520732",false,"NCT06060392","Effect of Oral Semaglutide on Liver Fat and Body Composition in Liver Transplant Recipients With Diabetes Mellitus","Effect of Oral Semaglutide on Liver Fat and Body Composition in Liver Transplant Recipients With Diabetes Mellitus: Sema-Lit","Sema-Lit","Inclusion Criteria:\n\n1. A man or woman, 30 years of age or above with liver transplantation of at least 3 months duration who meets all the following two criteria:\n\n   1. On standard anti-diabetic agents (metformin and\u002For insulin) with an HbA1c of \\\u003C=9% at screening\n   2. Body mass index of \\>25 kg\u002Fm2\n2. Subjects must be medically stable based on medical history, physical examination, and laboratory investigations.\n3. Subjects must be willing and able to adhere to the prohibitions and restrictions specified in this protocol.\n4. Each subject must sign an informed consent form (ICF) indicating that he or she understands the purpose of the study and are willing to participate in the study.\n\nExclusion Criteria:\n\n1. History of diabetic ketoacidosis, type 1 diabetes, pancreas or beta-cell transplantation, or diabetes secondary to pancreatitis or pancreatectomy.\n2. History of brittle or labile glycemic control, with widely varying glucose measurements by FPG or SMBG such that stable glucose control over the treatment period would be unlikely.\n3. History of drug or alcohol abuse according to Diagnostic and Statistical Manual of Mental Disorders (5th edition) (DSM-V) criteria within 3 years before Screening, or an Alcohol Use Disorders Identification Test (AUDIT) with a score \\>=8, or alcohol consumption of more than 20 g per day in the case of women and more than 30 g per day in the case of men for at least three consecutive months during the previous 5 years.\n4. Thyroid stimulating hormone (TSH) value that is either \\\u003C 0.45 mIU\u002FL or \\>10 mIU\u002FL at Screening.\n\n   Note: Subjects on thyroid hormone replacement therapy must be on a stable dose and dosing regimen for at least 4 weeks prior to enrollment.\n5. Use of a PPAR-γ agonist \\[e.g., a thiazolidinedione (pioglitazone\\], an SGLT2 inhibitor (e.g., canagliflozin, empagliflozin, dapagliflozin) or GLP-1 receptor agonists (e.g., liraglutide, dulaglutide) within 12 weeks before the enrollment.\n6. Ongoing eating disorder, or a significant weight loss or weight gain within 12 weeks before the Screening visit, defined as an increase or decrease of 5% in body weight based upon clinic-based measurement or, if not available, based on subject's report.\n7. Myocardial infarction, unstable angina, pulmonary hypertension, revascularization procedure (e.g., stent or bypass graft surgery), or cerebrovascular accident within 3 months before Screening, or revascularization procedure is planned, or subject has a history of New York Heart Association (NYHA) Class III-IV cardiac disease.\n8. Use of vitamin E within 4 weeks before screening.\n9. History of prior bariatric (e.g., Roux-en-Y gastric bypass) or other major upper gastrointestinal surgical procedure (including gastric resection).\n10. History of diabetic gastroparesis (or symptoms suggestive of this disorder, including postprandial bloating or vomiting), malabsorption, inflammatory bowel disease, or any other chronic, clinically important gastrointestinal disorder.\n11. Estimated glomerular filtration rate (eGFR) \\\u003C45 mL\u002Fmin\u002F1•73 m2 using the Modification of Diet in Renal Disease Study (MDRD) equation.\n12. Subjects with a history of having or possibly having metallic material in the body or any contraindication for a MR examination.\n13. Claustrophobia, or anxiety related to previous negative experiences with magnetic resonance imaging procedures or if the subject is unwilling to participate in magnetic resonance imaging procedures.\n14. Clinically important hematologic disorder (e.g., symptomatic anemia, proliferative bone marrow disorder, thrombocytopenia) at Screening.\n15. History of human immunodeficiency virus (HIV) antibody positive at Screening.\n16. Contraindications to the use of oral semaglutide (per ORAL SEMAGLUTIDE Prescribing Information).\n17. Pregnancy or women breastfeeding or planning to become pregnant while enrolled in this study.\n18. History of significant cardiac, vascular, pulmonary, renal, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric disturbances.\n19. Patients with history of myopathies or evidence of active muscle disease.","ALL","30 Years",{"count":20,"type":21},50,"ESTIMATED","INTERVENTIONAL",[24],"NA","Nonalcoholic fatty liver disease (NAFLD) is a spectrum of liver conditions ranging from liver steatosis (NAFL), steatohepatitis (NASH), advanced liver fibrosis and ultimately leads to cirrhosis in a significant proportion of individuals. NAFLD is intimately associated with insulin resistance and associated disorders, such as obesity, type 2 diabetes, metabolic syndrome, and dyslipidemia.\n\nIt has been noted that several individuals with liver transplantation develop nonalcoholic fatty liver disease in the transplanted liver. This is because of the presence of various risk factors of obesity and NAFLD, such as decreased physical activity, that persist following liver transplantation. Post-liver transplant patients are particularly at risk for developing NAFLD, as these patients are on oral steroids and immunosuppressants for a significant period of time.\n\nThere is no medication approved for the prevention or treatment of NAFLD. Semaglutide is an GLP-1 receptor agonist that have been approved for the treatment of type 2 diabetes and obesity. Semaglutide has also been demonstrated to have beneficial effects on NAFLD. However, there is no data on the effect of semaglutide on liver fat accumulation or changes in body composition in patients following liver transplantation. Therefore, the current pilot study is planned to evaluate the effect of oral semaglutide on the liver fat, liver enzymes and body composition in patients undergoing liver transplantation",[27,28],"Liver Transplant; Complications","Diabete Mellitus","RECRUITING","2025-06-12",{"date":32,"type":33},"2025-06-13","ACTUAL",{"date":35,"type":33},"2023-10-30",{"date":37,"type":21},"2025-11-01",{"name":39,"class":40},"Medanta, The Medicity, India","OTHER",1,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":17,"minAge":50,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":22,"phases":53,"briefSummary":54,"conditions":55,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":58,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":41},"100518848","effect-of-bempedoic-acid-on-liver-fat-in-individuals-with-nonalcoholic-fatty-liver-disease-and-type-2-diabetes-100518848","NCT06035874","Effect of Bempedoic Acid on Liver Fat in Individuals With Nonalcoholic Fatty Liver Disease and Type 2 Diabetes","Effect of Bempedoic Acid on Liver Fat in Individuals With Nonalcoholic Fatty Liver Disease and Type 2 Diabetes: Randomized Controlled Trial","B-LIFT","Inclusion Criteria:\n\n1. A man or woman, 20 years of age or above with the diagnosis of type 2 diabetes for at least 3 months who meets all the following two criteria:\n\n   1. On standard anti-diabetic agents (metformin, DPP-4 inhibitors, sulphonylureas or insulin, in any combination) with an HbA1c of \\\u003C9% at screening\n   2. Have documented hepatic steatosis (MRI-PDFF \\>5.6%) on screening MRI- PDFF\n2. Participants must be medically stable based on medical history, physical examination and laboratory investigations.\n3. Participants must be willing and able to adhere to the prohibitions and restrictions specified in this protocol.\n4. Each participant must sign an informed consent form (ICF) indicating that he or she understands the purpose of the study and are willing to participate in the study.\n\nExclusion Criteria:\n\n1. History of diabetic ketoacidosis, type 1 diabetes, pancreas or beta-cell transplantation, or diabetes secondary to pancreatitis or pancreatectomy.\n2. History of brittle or labile glycemic control, with widely varying glucose measurements by FPG or SMBG such that stable glucose control over the treatment period would be unlikely.\n3. History of drug or alcohol abuse according to Diagnostic and Statistical Manual of Mental Disorders (5th edition) (DSM-V) criteria within 3 years before Screening, or an Alcohol Use Disorders Identification Test (AUDIT) with a score \\>8, or alcohol consumption of more than 20 g per day in the case of women and more than 30 g per day in the case of men for at least three consecutive months during the previous 5 years.\n4. Thyroid stimulating hormone (TSH) value that is either \\\u003C 0.45 mIU\u002FL or \\>10 mIU\u002FL at Screening. Note: Subjects on thyroid hormone replacement therapy must be on a stable dose and dosing regimen for at least 4 weeks prior to enrollment.\n5. Use of a PPAR-γ agonist \\[e.g., a thiazolidinedione (pioglitazone\\], an SGLT2 inhibitor (e.g., canagliflozin, empagliflozin, dapagliflozin), GLP-1 receptor agonists (e.g., liraglutide, dulaglutide) or saroglitazar (Dual PPARα\u002Fγ agonist) within 12 weeks before the enrollment.\n6. BMI \\>40 kg\u002Fm2.\n7. Ongoing eating disorder, or a significant weight loss or weight gain within 12 weeks before the Screening visit, defined as an increase or decrease of 5% in body weight based upon clinic-based measurement or, if not available, based on subject's report.\n8. Use of weight loss medication (prescription and\u002For over the counter) within 3 months prior to Screening or have participated in a weight loss\u002Fdiet program within 12 months prior to Screening.\n9. Renal disease that required treatment with immunosuppressive therapy or a history of dialysis or renal transplant.\n10. Myocardial infarction, unstable angina, pulmonary hypertension, revascularization procedure (e.g., stent or bypass graft surgery), or cerebrovascular accident within 3 months before Screening, or revascularization procedure is planned, or subject has a history of New York Heart Association (NYHA) Class III-IV cardiac disease.\n11. History of hepatitis B surface antigen (HBsAg) or hepatitis C antibody (anti-HCV) positive, or other clinically active liver disease, or tests positive for HBsAg or anti- HCV at Screening.\n12. Use of vitamin E within 12 weeks before screening.\n13. History of prior bariatric (e.g., Roux-en-Y gastric bypass) or other major upper gastrointestinal surgical procedure (including gastric resection).\n14. History of diabetic gastroparesis (or symptoms suggestive of this disorder, including postprandial bloating or vomiting), malabsorption, inflammatory bowel disease, or any other chronic, clinically important gastrointestinal disorder.\n15. Estimated glomerular filtration rate (eGFR) \\\u003C60 mL\u002Fmin\u002F1•73 m2 using the Modification of Diet in Renal Disease Study (MDRD) equation.\n16. Subjects with a history of having or possibly having metallic material in the body or any contraindication for a MR examination.\n17. Claustrophobia, or anxiety related to previous negative experiences with magnetic resonance imaging procedures or if the subject is unwilling to participate in magnetic resonance imaging procedures.\n18. Clinically important hematologic disorder (e.g., symptomatic anemia, proliferative bone marrow disorder, thrombocytopenia) at Screening.\n19. History of human immunodeficiency virus (HIV) antibody positive at Screening.\n20. Major surgery (e.g., requiring general anesthesia) within 12 weeks before Screening, or will not have fully recovered from surgery, or has surgery planned during the time the subject is expected to participate in the study.\n21. Contraindications to the use of bempedoic acid (per BEMPEDOIC ACID Prescribing Information).\n22. Current use of a corticosteroid medication or immunosuppressive agent, or likely to require treatment with a corticosteroid medication or an immunosuppressive agent.","20 Years",{"count":52,"type":21},100,[24],"Nonalcoholic fatty liver disease (NAFLD) is a spectrum of liver conditions ranging from liver steatosis (NAFL), steatohepatitis (NASH), advanced liver fibrosis and ultimately leads to cirrhosis in a significant proportion of individuals. NAFLD is intimately associated with insulin resistance and associated disorders, such as type 2 diabetes, metabolic syndrome and dyslipidemia.\n\nBempedoic acid, an ATP-citrate lyase inhibitor, is recently approved for patients with dyslipidemia as a second line drug. Bempedoic acid reduces liver fat in mice model of NASH. Data regarding the effect of bempedoic acid on human liver fat are scarce. Therefore, the current study is planned to evaluate the effect of bempedoic acid versus standard treatment on liver and pancreatic fat content in patients with NAFLD",[56,57],"Type 2 Diabetes","Non Alcholic Fatty Liver Disease",{"date":32,"type":33},{"date":60,"type":33},"2023-10-15",{"date":62,"type":21},"2025-10-01",{"name":39,"class":40},{"id":65,"slug":66,"hasResults":11,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":70,"eligibilityCriteria":71,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":72,"targetDuration":4,"studyType":22,"phases":74,"briefSummary":75,"conditions":76,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":82,"completionDateStruct":83,"leadSponsor":85,"locationsCount":41},"100523423","effect-of-empagliflozin-vs-linagliptin-on-glycemic-outcomesrenal-outcomes--body-composition-in-renal-transplant-recipients-with-diabetes-mellitus-100523423","NCT06095492","Effect of Empagliflozin vs Linagliptin on Glycemic Outcomes,Renal Outcomes & Body Composition in Renal Transplant Recipients With Diabetes Mellitus","Effect of Empagliflozin Versus Linagliptin on Glycemic Outcomes, Renal Outcomes and Body Composition in Renal Transplant Recipients With Diabetes Mellitus: Randomized Controlled Trial (EmLina Renal Trial)","EmLinaRenal","Inclusion Criteria:\n\n1. A man or woman, 30 years of age or above with the diagnosis of diabetes mellitus (pre-transplantation type 2 diabetes or post-transplantation diabetes mellitus) and after at least 3 months of renal transplantation.\n2. Patients must have stable renal function (less than 20% deviation in serum creatinine in last one month: eGFR \\>30 ml\u002Fmin\u002F1.73 m2)\n3. Patients must be on a stable immunotherapy for last one month.\n4. Subjects must be medically stable on the basis of medical history, physical examination and laboratory investigations.\n5. Subjects must be willing and able to adhere to the prohibitions and restrictions specified in this protocol.\n6. Each subject must sign an informed consent form (ICF) indicating that he or she understands the purpose of the study and are willing to participate in the study.\n\nExclusion Criteria:\n\n1. History of diabetic ketoacidosis, type 1 diabetes, pancreas or beta-cell transplantation, or diabetes secondary to pancreatitis or pancreatectomy.\n2. History of brittle or labile glycemic control, with widely varying glucose measurements by FPG or SMBG such that stable glucose control over the treatment period would be unlikely.\n3. BMI \\\u003C=18 kg\u002Fm2\n4. Ongoing eating disorder, or a significant weight loss or weight gain within 12 weeks before the Screening visit, defined as an increase or decrease of 5% in body weight based upon clinic-based measurement or, if not available, based on subject's report.\n5. Estimated glomerular filtration rate (eGFR) \\\u003C30 mL\u002Fmin\u002F1•73 m2 using the Modification of Diet in Renal Disease Study (MDRD) equation.\n6. Contraindications to the use of empagliflozin or linagliptin (per Prescribing Information).\n7. History of recurrent urinary tract infections.",{"count":73,"type":21},200,[24],"In the early postoperative period, hyperglycemia is frequently seen in renal transplant recipients primarily because of high doses of immunosuppressive therapy. Many of these patients have pre-existing type 2 diabetes (T2D). However, 10-20% of renal transplant recipients develop new onset persisting hyperglycemia following renal transplantation, known as posttransplant diabetes mellitus (PTDM). These patients need optimal glycemic control in order to prevent development of cardiovascular and de novo renal disease. Most of these patients receive insulin therapy following transplantation, as they receive steroid therapy and oral hypoglycemic agents are better avoided. However, as steroids are tapered and need for insulin diminishes, several anti-diabetic agents are initiated off-label, such as metformin, DDP-4 inhibitors and sulfonylureas. Sodium-glucose cotransporter-2 (SGLT2) inhibitors exhibit nephroprotective effects in individuals with native kidney disease, with or without type 2 diabetes. However, the data regarding the safety and glycemic efficacy of these glucose-lowering agents in the renal transplant setting are scarce.\n\nDPP-4 inhibitors are glucose-lowering agents used in patients with CKD. For instance, linagliptin is used in all eGFRs without dose modification. The data regarding the safety and efficacy of linagliptin are scarce in patients following renal transplantation.\n\nSince patients following renal transplantation receive immunosuppressants and steroids, which may affect their body composition. Effect of SGLT2 inhibitors or DPP-4 inhibitors on body composition in patients following renal transplantation is not well established.\n\nIn this study, we aimed to examine the safety and effect of empagliflozin (an SGLT2 inhibitor) versus linagliptin (an DDP-4 inhibitor) on the glycemic outcomes, renal outcomes and body composition in renal transplant recipients with diabetes mellitus.",[77,78],"Kidney Transplant; Complications","Diabetes Mellitus","2024-12-04",{"date":81,"type":33},"2024-12-05",{"date":35,"type":33},{"date":84,"type":21},"2025-12-01",{"name":39,"class":40},""]