[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"diabetic-cardiomyopathies\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:diabetic-cardiomyopathies":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,50,81,109],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":29,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100512919","mitochondrial-substrate-utilization-in-the-diabetic-human-heart-100512919",false,"NCT05958706","Mitochondrial Substrate Utilization in the Diabetic Human Heart","Inclusion Criteria:\n\n* Age ≥ 20 and ≤ 85 years\n* Male and female patients with manifest heart failure (NYHA II-IV) and clinical indication for myocardial biopsy or after transplantation and clinical indication for myocardial biopsy with or without type II diabetes mellitus or terminal (NYHA IV) heart failure with or without type II diabetes mellitus.\n* Written informed consent\n\nExclusion Criteria:\n\n* Acute infectious diseases within the last 2 weeks before the examination\n* Autoimmune diseases or acute immunocompromising diseases (leukocytes \\\u003C 5000\u002Fμl)\n* Pregnancy\n* Use of alcohol or drugs (addiction), psychiatric diseases\n* Suspected or manifest AIDS (HIV); hepatitis B or C.\n* Liver disease not attributed to the presence of nonalcoholic fatty liver hepatitis or congestive hepatopathy in heart failure\n* Malignant cancer\n* Lack of capacity to give informed consent or lack of consent to participate in the study\n* For MRI study with drug stress: contraindications to the use of regadenoson, specifically: a) Hypersensitivity to the active ingredient or any of the other ingredients mentioned. b) Second- or third-degree atrioventricular (AV) block or sinus node dysfunction, unless these patients have a functioning pacemaker. c) Unstable angina that has not been stabilized with medication. d) Severe hypotension. e) Decompensated stages of heart failure.","ALL","20 Years","85 Years",{"count":19,"type":20},500,"ESTIMATED","OBSERVATIONAL","Diabetes can lead to heart failure independently, but the underlying causes remain incompletely understood. The main aim of this study is to identify differential regulation of mitochondrial substrate utilization and complex activity in heart failure and type 2 diabetes mellitus (T2DM). For this, we will conduct a prospective, observational study to examine myocardial mitochondrial oxidative function and related metabolic parameters, gene expression, histological markers, and inflammation in cardiac tissue from patients with heart failure or patients after heart transplantation. We will further assess cardiac function using cardiac magnetic resonance imaging with and without stress protocols and magnetic resonance spectroscopy. Glycemic control\u002FT2DM will be characterized by oral glucose tolerance tests. The results of this project will help to better understand the cellular mechanisms of the development of diabetic cardiomyopathy and contribute to the development of early diagnostic, as well as therapeutic approaches for the prevention and treatment of diabetic cardiomyopathy.",[24,25,26,27,28],"Heart Failure","Type2diabetes","Insulin Resistance","Mitochondrial Diseases","Diabetic Cardiomyopathies",[30,31,32,33,34,35,36],"mitochondrial function","respirometry","heart failure","type 2 diabetes mellitus","insulin resistance","mitochondrial disease","diabetic cardiomyopathy","RECRUITING","2026-02-17",{"date":40,"type":41},"2026-02-19","ACTUAL",{"date":43,"type":41},"2021-12-01",{"date":45,"type":20},"2035-06",{"name":47,"class":48},"Heinrich-Heine University, Duesseldorf","OTHER",1,{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":15,"minAge":57,"maxAge":4,"enrollmentInfo":58,"targetDuration":4,"studyType":60,"phases":61,"briefSummary":64,"conditions":65,"keywords":67,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":49},"100610104","phase-2-tailored-exercise-training-study-among-adults-with-hfpef-100610104","NCT07223242","Tailored Exercise Training Study Among Adults With HFpEF","TEXPEF","Inclusion Criteria:\n\n1. Age\\>= 18 yrs\n2. LVEF (Left Ventricular Ejection Fraction) \\>= 50%\n3. History of HFpEF or at risk of HFpEF\n\n   1. HFpEF diagnosis based on:- -HF hospitalization within 12 months-\n\n      * NT-proBNP \\>360 pg\u002FmL\n   2. Risk of HFpEF based on:-\n\n      * \\>2 risk factors (h\u002Fo diabetes, hypertension, obesity, physical inactivity by self-report)\n4. SPPB \\\u003C 10 or VO2\\\u003C60th percentile\n5. BMI \\>=28 (for randomization in phase II)\n6. Able to use cell phone and mobile application\n\nExclusion Criteria:\n\n1. Hospitalization 1 month prior to baseline visit\n2. History of recurrent falls\n3. eGFR (Estimated Glomerular Filtration Rate) \\\u003C20ml\u002Fmin\u002F1.73m\n4. Active changes in HF therapies over 2 weeks prior to baseline visit\n5. Inability participate in exercise training therapy\n6. Inability to perform CPET (Cardiopulmonary Exercise Testing) testing\n7. Severe left side valvular heart disease\n8. End stage pulmonary disease, requiring continuous supplemental oxygen\n9. Major surgery within 3 months of screening or major elective surgery during the duration of the study.\n10. Unstable weight defined by \\>5% change in body weight in last 30 days before first study visit.\n11. Pregnancy","18 Years",{"count":59,"type":20},120,"INTERVENTIONAL",[62,63],"PHASE2","PHASE3","Heart failure with preserved ejection fraction (HFpEF) is associated with a high morbidity and mortality burden. There are limited pharmacological options available for the treatment of HFpEF. Exercise intolerance (EI) is the cardinal symptom of HFpEF, which manifests as dyspnea and fatigue. EI leads to functional deconditioning and reduced quality of life (QOL), both of which elevate risk of death and hospitalization in patients with HFpEF. Supervised exercised training is associated with improvements in exercise capacity and QOL in adults with HFpEF. However, supervised exercise has not been widely utilized for the treatment of HFpEF due to logistical and fiscal barriers.\n\nThis study will investigate the effects of a remote exercise training intervention on exercise capacity and skeletal muscle composition in patients with HFpEF, or those at risk for it. In addition, it will compare four different lifestyle interventions for their effects on exercise capacity.",[66,28],"HFpEF - Heart Failure With Preserved Ejection Fraction",[68,69,70,71],"Diabetic cardiomyopathy","Remote exercise training","Weight loss","Rehab","2025-10-28",{"date":74,"type":41},"2025-10-31",{"date":76,"type":41},"2025-02-18",{"date":78,"type":20},"2026-12-30",{"name":80,"class":48},"University of Texas Southwestern Medical Center",{"id":82,"slug":83,"hasResults":11,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":87,"eligibilityCriteria":88,"healthyVolunteers":89,"sex":15,"minAge":57,"maxAge":4,"enrollmentInfo":90,"targetDuration":4,"studyType":60,"phases":92,"briefSummary":94,"conditions":95,"keywords":96,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":49},"100407915","the-dapa-memri-trial-100407915","NCT04591639","The DAPA-MEMRI Trial","An Observational Cross-sectional Study and a Double-blind Placebo Controlled Randomised Controlled Trial to Assess the Effect of Dapagliflozin on Myocardial Calcium-handling in Patients With Heart Failure- The DAPA-MEMRI Trial.","DAPA-MEMRI","Inclusion Criteria:\n\nPatients with heart failure (with or without type 2 diabetes mellitus)\n\n* Aged over 18 years\n* Diagnosis of symptomatic reduced ejection fraction heart failure for at least 2 months\n* Left ventricular ejection fraction ≤40%\n* Elevated N-terminal pro B-type natriuretic peptide (\\>125 pg\u002FmL)\n* Clinical diagnosis of type 2 diabetes mellitus for 50% of patient population - on stable therapy for at least 12 months or more.\n\nPatients with Type 2 Diabetes Mellitus and no heart failure\n\n* Aged over 18 years\n* Clinical diagnosis of type 2 diabetes mellitus (diagnosed by either HbA1c of 48mmol\u002Fmol (6.5%) or greater or fasting plasma glucose level of 7mmol\u002FL or greater at the time of diagnosis)\n\n  \\- on stable therapy for at least 12 months or more.\n* Normal left ventricular systolic ejection fraction\n\nHealthy Volunteers\n\n* Aged over 18 years\n* Normal left ventricular ejection fraction and glycaemia\n* No clinically significant co-morbid conditions\n\nExclusion Criteria:\n\nPatients with heart failure (with or without type 2 diabetes mellitus)\n\n* Receiving an SGLT2 inhibitor within 8 weeks of enrolment\n* Previous intolerance of, or contraindication to, an SGLT2 inhibitor\n* Standard magnetic resonance imaging safety exclusions\n* Severe renal impairment (eGFR \\\u003C30millilitre\u002Fmin. 1.73m2)\n* Type 1 diabetes mellitus\n* Symptomatic hypotension or systolic blood pressure \\\u003C95 mmHg\n* Recent (within 12 weeks) hospitalisation for heart failure, acute cardiovascular event (such as myocardial infarction or stroke) or coronary re-vascularisation.\n* 2nd or 3rd degree atrioventricular block Atrial fibrillation or flutter with poor ventricular rate control (\\>100 \u002Fmin)\n* Heart failure due to restrictive cardiomyopathy, active myocarditis, constrictive pericarditis, hypertrophic (obstructive) cardiomyopathy or uncorrected primary valvular disease\n* New York Heart Association grade IV heart failure\n* Obstructive liver function testing abnormalities\n* Concomitant digoxin, diltiazem or verapamil therapy.\n\nPatients with type 2 diabetes mellitus and no heart failure\n\n* Other major clinically significant co-morbid conditions\n* History of ischaemic heart disease or present history suggestive of probable clinically significant underlying ischaemic heart disease\n* Standard magnetic resonance imaging safety exclusions\n* Moderate or severe renal impairment (eGFR \\\u003C45 mL\u002Fmin. 1.73m2)\n* Receiving a SGLT2 inhibitor at any time\n* Symptomatic hypotension or systolic blood pressure \\\u003C95 mmHg\n* Abnormal electrocardiogram\n* Clinically significant abnormalities of clinical haematology or biochemistry measurements.\n\nHealthy Volunteers\n\n* Major or clinically significant cardiovascular disease\n* Diabetes mellitus\n* Receiving an SGLT2 inhibitor at any time\n* Standard magnetic resonance imaging safety exclusions\n* Moderate or severe renal impairment (eGFR \\\u003C45 mL\u002Fmin. 1.73m2)\n* Symptomatic hypotension or systolic blood pressure \\\u003C95 mmHg\n* Abnormal electrocardiogram\n* Clinically significant abnormalities of clinical haematology or biochemistry measurements.",true,{"count":91,"type":20},160,[93],"NA","Diabetes mellitus is among the top 10 causes of death worldwide with an increasing incidence. Patients with diabetes are at risk of developing heart failure which is characterised by significant changes in the heart muscle including scarring and thickening. Contraction of the heart involves movement of calcium across the heart muscle and disruption of this process is an early change seen in heart failure. Recently, a drug therapy (SGLT2 inhibitor therapy) in patients with diabetes was shown to benefit patients with heart failure but the mechanisms of benefit are unknown.\n\nOur hypothesis is that calcium handling is altered in patients with either type 2 diabetes mellitus (T2DM) or heart failure and that SGLT2 inhibitors can improve this in heart failure irrespective of the presence of T2DM.\n\nScanning the heart using magnetic resonance imaging (MRI) enables detailed assessment of its structure and function by using a new contrast 'dye' containing manganese that has shown advantages over traditional contrast. We plan to further test this new dye as it has the potential to track and quantify improvements in heart function over time and detect changes in calcium handling in the heart muscle, making it an ideal measure to identify the mechanisms of benefit from SGLT2 inhibitor therapy.\n\nThe study population will comprise patients with heart failure with and without type 2 diabetes, patients with type 2 diabetes without heart failure and healthy volunteers. Baseline comparisons will be made between the four groups before progressing to the randomised controlled trial with heart failure patients only. Patients will have a clinical assessment and blood tests, electrocardiogram, echocardiogram and MRI of the heart at each visit.\n\nIf successful, this study will give us significant insights into mechanisms of action of SGLT2 inhibitors in heart failure and will enable us to tailor specific treatments in heart failure patients.",[24,28],[97,98,99],"Heart failure","Sodium glucose Co-transporter 2 inhibitor therapy","Manganese enhanced cardiac magnetic resonance imaging","2025-06-23",{"date":102,"type":41},"2025-06-24",{"date":104,"type":41},"2020-08-19",{"date":106,"type":20},"2028-07-28",{"name":108,"class":48},"University of Edinburgh",{"id":110,"slug":111,"hasResults":11,"nctId":112,"briefTitle":113,"officialTitle":113,"acronym":114,"eligibilityCriteria":115,"healthyVolunteers":89,"sex":15,"minAge":116,"maxAge":117,"enrollmentInfo":118,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":120,"conditions":121,"keywords":123,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":126,"lastUpdatePostDateStruct":127,"startDateStruct":129,"completionDateStruct":131,"leadSponsor":133,"locationsCount":49},"100295915","prevalence-and-determinants-of-subclinical-cardiovascular-dysfunction-in-adults-with-type-2-diabetes-mellitus-100295915","NCT03132129","Prevalence and Determinants of Subclinical Cardiovascular Dysfunction in Adults With Type 2 Diabetes Mellitus","PREDICT","Inclusion Criteria:\n\n* Participant is willing and able to give informed consent for participation in the study.\n* Male or Female, aged ≥18 and ≤75 years.\n* Diagnosed with Stable type 2 diabetes (determined by: i) formal diagnosis in GP case records, ii) a record of diagnostic oral glucose tolerance test OR glycated haemoglobin level ≥6.5%).\n\nExclusion Criteria:\n\n* Angina pectoris or limiting dyspnoea (\\>NYHA II),\n* Major atherosclerotic disease: Symptomatic CAD, history of myocardial infarction, previous revascularisation, stroke\u002Ftransient ischaemic attack or symptomatic peripheral vascular disease.\n* Atrial fibrillation or flutter.\n* Moderate or severe valvular heart disease.\n* History of heart failure or cardiomyopathy.\n* Type 1 diabetes mellitus (T1DM).\n* Low fasting C-peptide levels suggestive of adult-onset T1DM.\n* Stage III-V renal disease (estimated glomerular filtration rate ≤30ml\u002Fmin\u002F1.73m2).\n* Absolute contraindications to CMR.\n\nImportantly, patients with subclinical CAD, and other common comorbidities such as obesity and hypertension, will not be excluded from this study. This will enable us to evaluate the contribution of CAD to myocardial dysfunction in diabetes and ensures our study group is representative of the general population with diabetes. Similarly, as mild dyspnoea is extremely common and non-specific participants with mild dyspnoea will be included.","50 Years","75 Years",{"count":119,"type":20},593,"Background: Heart failure is a major cause of morbidity and mortality in diabetes mellitus, but its pathophysiology is poorly understood.\n\nAim: To determine the prevalence and determinants of subclinical cardiovascular dysfunction in adults with type 2 diabetes (T2D).\n\nPlan: 518 asymptomatic adults (aged 18-75 years) with T2D will undergo comprehensive evaluation of cardiac structure and function using cardiac MRI (CMR) and spectroscopy, echocardiography, CT coronary calcium scoring, exercise tolerance testing and blood sampling. 75 controls will undergo the same evaluation.\n\nPrimary hypothesis: myocardial steatosis is an independent predictor of left ventricular global longitudinal strain. Secondary hypotheses: will assess whether CMR is more sensitive to detect early cardiac dysfunction than echocardiography and BNP, and whether cardiac dysfunction is related to peak oxygen consumption.\n\nExpected value of results: This study will reveal the prevalence and determinants of cardiac dysfunction in T2D, and could provide targets for novel therapies.",[122,28],"Diabetes Mellitus, Type 2",[124,68,125],"Type 2 diabetes","Cardiovascular magnetic resonance","2024-01-03",{"date":128,"type":41},"2024-01-05",{"date":130,"type":41},"2017-10-24",{"date":132,"type":20},"2029-10-31",{"name":134,"class":48},"University of Leicester"]