ITMCTR2100004887招募中4 期
Effects of Xuezhikang vs Pravastatin on triglyceride level in patients with Type 2 Diabetes Mellitus and Dyslipidemia: a multicenter, prospective, randomized controlled study
试验速览
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional study
入排标准
- 年龄范围
- 18 至 —（—）
- 性别
- All
入选标准
- •1. Aged >= 18 years.
- •2. Diagnosed type 2 diabetes patients, according to the Diabetes Medical Diagnosis and Treatment Standards established by the American Diabetes Association (ADA) in 2020, need to meet any of the following criteria:
- •(1) Fasting plasma glucose >= 7.0mmol/L, fasting state means no calorie intake for at least 8 hours;
- •(2) OGTT 2 hours plasma glucose >= 11.1mmol/L, OGTT method according to WHO standard, oral anhydrous glucose powder 75g;
- •(3) HbA1c>=6.5%, HbA1c detection adopts NGSP and DCCT certification methods;
- •(4) Patients with typical symptoms of hyperglycemia or risk of hyperglycemia, random blood glucose >= 11.1mmol/L, and treatment of diabetes under the guidance of an endocrinologist during the study period.
- •3. At least one of the following conditions exists:
- •(1) History of type 2 diabetes >=10 years;
- •(2) Smoking;
- •(3) Obesity [BMI >= 28Kg/m^2, or waist circumference>=90cm (male) or >= 85cm (female)];
- •(4) Hypertension;
- •(5) Fasting HDL-C < 1.0mmol/L or LDL-C >= 2.6mmol/L in the past four weeks.
- •4. Abnormal blood lipids in the past 4 weeks must meet the following two conditions at the same time:
- •(1) 1.7mmol/L <= Fasting TG < 5.6mmol/L;
- •(2) 1.8mmol/L <= fasting LDL-C < 4.9mmol/L.
- •5. During the study period, the selected patients are willing to accept and comply with dietary education.
- •6. The patient must be able to comply with regular visits, treatment plans and all laboratory tests.
- •7. Sign informed consent and take the test voluntarily.
排除标准
- •1. Patients suffering from atherosclerotic cardiovascular diseases, including coronary atherosclerotic heart disease, ischemic stroke, transient ischemic attack, peripheral artery disease, etc.;
- •2. Patients who have taken lipid-lowering drugs in the past three months;
- •3. Diabetic patients who have not controlled their blood sugar well, that is, HbA1c%>=8.0%;
- •4. Active hepatitis or unexplained continuous increase in serum aminotransferase or serum aminotransferase level greater than 3 times the upper limit of normal;
- •5. Patients with myopathy or increased serum creatine kinase that cannot be explained by muscle damage (greater than 5 times the upper limit of normal);
- •6. Patients who are allergic to Xuezhikang or pravastatin, and take glucocorticoids or contraceptives for a long time;
- •7. In the acute stage of various infectious diseases, suffering from hyperthyroidism or hypothyroidism, acute cerebrovascular disease, severe heart or renal insufficiency ( > CKD3 stage), malignant tumor, hematopoietic system disease, autoimmune system disease, severe impact Patients with digestive or/and absorptive digestive diseases, mental diseases, severe or unstable physical diseases;
- •8. Abuse or dependence on alcohol or drugs in the past three months;
- •9. Patients who have participated in clinical trials of other drugs in the past three months;
- •10. The researcher believes that there are other situations that are not suitable for participating in the trial.
研究者
相似试验
已完成
4 期
The Effect of XueZhiKang on Fatigue：Comparing With SimvastatinDyslipidemiasNCT01686451Wenzhou Medical University60
Unknown
4 期
Effects and Underlying Mechanism of Lipid Lowering Intervention on Vascular Protection in Hypertensive PatientsHypertensionNCT02254824Chinese Academy of Medical Sciences, Fuwai Hospital300
招募中
4 期
Effect of simvastatin on myocardial triglyceride accumulation, cardiac function and al vessel wall thickness in patients with type 2 diabetes mellitusdiabetes mellitus complications100192801001265310003216NL-OMON32611eids Universitair Medisch Centrum20
进行中（未招募）
不适用
Effect of simvastatin on myocardial triglyceride accumulation, cardiac function and vessel wall thickness in patients with type 2 diabetes mellitus - SIMTACdiabetes mellitus type 2MedDRA version: 9.1Level: LLTClassification code 10012601Term: Diabetes mellitusEUCTR2008-004853-13-NLMC
已完成
4 期
Treatment With Rosuvastatin Versus Switching PI (Protease Inhibitor) in Patients HIV With High Cholesterol LevelsHIVHypercholesterolaemiaNCT01935674Juan A. Arnaiz43