[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"dyslipidemia-associated-with-type-ii-diabetes-mellitus\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:dyslipidemia-associated-with-type-ii-diabetes-mellitus":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,46,74],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100620552","moderate-intensity-statin-vs-individualized-ldl-c-target-based-therapy-in-older-adults-with-type-2-diabetes-itarget-elderly-study-100620552",false,"NCT07359105","Moderate-intensity Statin vs. Individualized LDL-C Target-based Therapy in Older Adults With Type 2 Diabetes (iTARGET-Elderly Study)","A Registry-based Randomized Controlled Trial of Moderate-intensity Statin Therapy vs. Individualized Low-density Lipoprotein Cholesterol Target-based Therapy for Primary Prevention of Cardiovascular Events in Patients 70 Years of Age or Older With Type 2 Diabetes (iTARGET-Elderly Study)","Inclusion Criteria:\n\n* Provision of written informed consent to participate in the study by the patient or his\u002Fher legally authorized representative after receiving and understanding a detailed explanation of the study\n* Adults aged 70 years or older\n* Diagnosed with type 2 diabetes or currently receiving antidiabetic medication, without a history or presence of cardiovascular disease\n* Either: (1) LDL-C≥100 mg\u002FdL if not receiving lipid-lowering therapy, or (2) currently receiving lipid-lowering therapy (in this case, LDL-C level not restricted)\n\nExclusion Criteria:\n\n* Diagnosis of type 1 diabetes\n* Documented history of atherosclerotic cardiovascular disease at screening, confirmed clinically or by imaging: (1) myocardial infarction; (2) coronary revascularization; (3) currently receiving treatment for acute coronary syndrome; (4) history of ischemic stroke; (5) aortic aneurysm; (6) peripheral arterial disease\n* Currently undergoing cancer treatment\n* Severe disease requiring recurrent hospitalization\n* Frailty (defined as a score ≥3 on the Korean FRAIL questionnaire), or any condition significantly limiting self-care\n* AST or ALT \\>3 × ULN, at screening (however, patients will be eligible if repeat testing at the time of randomization shows levels \\\u003C3 × ULN), or liver cirrhosis\n* Contraindications to study drugs\n* Pregnant or breastfeeding women","ALL","70 Years",{"count":19,"type":20},2186,"ESTIMATED","INTERVENTIONAL",[23],"NA","Statins are the cornerstone of cardiovascular disease (CVD) prevention through the lowering of low-density lipoprotein cholesterol (LDL-C). While the benefits of intensive LDL-C lowering are well-established for secondary prevention, evidence remains insufficient for primary prevention in the elderly-specifically for individuals aged 70 years or older with type 2 diabetes who have no prior history of atherosclerotic cardiovascular events.\n\nCurrent guidelines generally recommend moderate-intensity statins for this population based on extrapolated data. However, there is a significant evidence gap regarding whether these older adults, who have not yet experienced a cardiovascular event, derive the same risk-benefit ratio from pharmacological intervention as younger or secondary prevention groups. Furthermore, while ezetimibe (alone or in combination) is an effective alternative for patients with established disease, its efficacy as a primary prevention strategy in older diabetic patients has not been rigorously confirmed through randomized controlled trials (RCTs).\n\nTherefore, this study specifically focuses on the primary prevention setting, aiming to determine whether individualized LDL-C target-based therapy is non-inferior to standard moderate-intensity statin therapy in preventing first-time cardiovascular events among older patients with type 2 diabetes.",[26],"Dyslipidemia Associated With Type II Diabetes Mellitus",[28,29,30,31,32,33],"Dyslipidemia","T2D","Diabetes","Statins","iTARGET-Elderly","RRCT","RECRUITING","2026-03-09",{"date":37,"type":38},"2026-03-10","ACTUAL",{"date":35,"type":38},{"date":41,"type":20},"2029-12-31",{"name":43,"class":44},"Sin Gon Kim","OTHER",2,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":16,"minAge":53,"maxAge":54,"enrollmentInfo":55,"targetDuration":4,"studyType":21,"phases":57,"briefSummary":59,"conditions":60,"keywords":61,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":73},"100408767","phase-3-efficacy-and-safety-of-berlim-2520-association-in-the-treatment-of-type-ii-diabetes-mellitus-and-dyslipidemia-100408767","NCT04602754","Efficacy and Safety of Berlim 25\u002F20 Association in the Treatment of Type II Diabetes Mellitus and Dyslipidemia.","National, Multicenter, Randomized, Double-blind, Triple-dummy, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Berlim 25\u002F20 Association in the Treatment of Type II Diabetes Mellitus and Dyslipidemia.","Inclusion Criteria:\n\n* Ability to confirm voluntary participation and agree to all trial purposes by signing and dating the informed consent forms;\n* Participants of both sexes, with age greater than or equal to 18 years and less than or equal to 85 years;\n* Participants presenting the diagnosis of type II diabetes mellitus, and who did not reach the therapeutic goals of HbA1c with previous dietary, physical exercise guidance and previous therapies at a stable dose in the last 3 months;\n* HbA1c ≥ 7,5% and ≤ 10,5% and fasting blood glucose \\> 100 mg\u002FdL at the screening visit;\n* Participants with high or very high cardiovascular risk according to the Brazilian guideline on the prevention of cardiovascular diseases in patients with diabetes (2017), which have not reached the goal of LDL-c ≤ 70 mg\u002FdL or ≤ 50 mg\u002FdL, respectively, with lifestyle changes, who are or aren't using low or moderate potency statins;\n* BMI (body mass index) \\> 19 Kg\u002Fm2 and ≤ 45 Kg\u002Fm2.\n\nExclusion Criteria:\n\n* Any clinical and laboratory findings that, in the judgment of the investigator, may interfere with the safety of research participants;\n* History of alcohol abuse or illicit drug use;\n* Participation in a clinical trial in the year prior to this study;\n* Pregnancy or risk of pregnancy and lactating patients;\n* Known hypersensitivity to the formula components used during the clinical trial;\n* Type 1 diabetes mellitus;\n* Fasting blood glucose \\> 300 mg\u002FdL;\n* Risk factors for volume depletion;\n* Participants with total cholesterol \\> 500 mg\u002FdL or triglycerides \\> 500 mg\u002FdL;\n* Impaired renal function and end-stage renal disease;\n* Participants with known heart failure, class III to IV (New York Heart Association);\n* Impaired hepatic function;\n* Medical history of pancreatic diseases that may suggest insulin deficiency;\n* Participants who had any cardiovascular event (acute myocardial infarction, acute coronary syndrome, recent onset stable angina, stroke, unstable congestive heart failure requiring treatment change), underwent revascularization or vascular surgery in the 6 months prior to screening;\n* Bariatric surgery in the last two years and\u002F or other gastrointestinal surgeries that can cause chronic malabsorption syndrome;\n* Condition that, in the investigator's judgment, may favor clinically significant changes in CPK levels;\n* Current medical history of cancer and\u002F or cancer treatment in the last 5 years;\n* Participants with known uncontrolled hypothyroidism or TSH levels \\> 5 mIU\u002FL;\n* History of known muscle disease or prior statin intolerance;\n* Participants using SGLT2 inhibitors, sulfonylureas and\u002For insulin therapy or PCSK9 inhibitors;\n* Participants who used other medications with prominent action in the control of serum triglyceride and cholesterol levels in the last 4 weeks or who are using low or moderate-intensity statins that cannot be replaced by rosuvastatin 20 mg;\n* Participants using medications that may interfere with triglyceride and cholesterol metabolism started less than 4 weeks ago or with dose adjustment in the last 4 weeks prior to the screening visit;\n* Treatment with anti-obesity drugs for less than 2 months or with dose change in the last 2 months.","18 Years","85 Years",{"count":56,"type":20},228,[58],"PHASE3","The purpose of this study is to evaluate the efficacy and safety of Berlim 25\u002F20 association in the treatment of type 2 diabetes mellitus and dyslipidemia.",[26],[28,62],"Type II Diabetes Mellitus","2025-12-01",{"date":65,"type":38},"2025-12-08",{"date":67,"type":38},"2023-12-01",{"date":69,"type":20},"2027-09",{"name":71,"class":72},"EMS","INDUSTRY",1,{"id":75,"slug":76,"hasResults":11,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":80,"eligibilityCriteria":81,"healthyVolunteers":11,"sex":16,"minAge":82,"maxAge":17,"enrollmentInfo":83,"targetDuration":4,"studyType":21,"phases":85,"briefSummary":86,"conditions":87,"keywords":93,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":73},"100434955","dietary-strategies-for-remission-of-type-2-diabetes-100434955","NCT04943926","Dietary Strategies for Remission of Type 2 Diabetes","Dietary Strategies for Remission of Type 2 Diabetes - a Randomized Controlled Trial (CARBCOUNT)","CARBCOUNT","Inclusion Criteria:\n\n* HbA1c ≥48 mmol\u002Fmol (with or without medical treatment)\n* Less than 10 years since the diagnosis of T2D\n* BMI ≥27 kg\u002Fm2 (≥25 kg\u002Fm2 for Asians)\n\nExclusion Criteria:\n\n* Treatment with insulin \\>25 IU\n* HbA1c concentration of 12% or more (≥108 mmol\u002Fmol)\n* Insulin to C-peptide ratio \\\u003C0.8 (indicative of insulin deficiency)\n* Myocardial infarction within the previous 6 months, and severe or unstable heart failure or other severe diseases including cancer, psychiatric\u002Feating disorders, severe depression and substance abuse","24 Years",{"count":84,"type":20},600,[23],"In this project, the investigators will perform a multicenter randomised controlled trial to determine whether advice to consume a moderate, whole food-based low-carbohydrate high-fat (LCHF) ad libitum diet (CarbCount program) can produce and maintain equal remission rates of type 2 diabetes (T2D) as a nutritionally complete very-low-calorie formula diet followed by a energy-restrictive (i.e., calorie counting) diet (DiRECT principles). Within the principles of each approach, the dietary goals and change will be adjusted according to individual needs\u002Fcapabilities conducive to long-term adherence. Furthermore, the investigators aim to determine whether the rate of diet-induced remission is reflected in\u002Fcan be predicted by baseline or diet-induced changes in glucose variability (e.g., time-in-range measured by continuous glucose monitoring) and other factors such as anthropometric changes and genetic susceptibility. Each center will also conduct locally-lead standalone mechanistic research, including analyses of intra-abdominal\u002Fhepatic fat accumulation, adipose tissue biopsies and\u002For measurements of energy metabolism. Additionally, changes in medication use, nutritional status, cardiovascular disease risk, as well as adverse events, will be monitored.",[88,89,90,91,92,26],"Diabetes Mellitus, Type 2","Overweight and Obesity","Hypertension","Glucose Intolerance","Insulin Resistance",[94,95,96,97,98],"Low-carbohydrate high-fat diet","Energy restricted diet","Lifestyle change","Ketogenic diet","Total meal replacement","2022-07-04",{"date":101,"type":38},"2022-07-08",{"date":103,"type":38},"2022-01-04",{"date":105,"type":20},"2040-12-31",{"name":107,"class":44},"University of Bergen"]