What is the Effects of Incretin on the Blood Pressure and Lipid in Overweight or Obese Diabetes Patients With Masked Hypertension: Liraglutide Plus Mitiglinide Comparing Metformin Plus Mitiglinide or Mitiglinide Alone（BLOOD STUDY）
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 90
- 主要终点
- Blood Pressure change
研究概览
简要总结
Obesity is one of the characteristics of type 2 diabetes mellitus. Most of the obese diabetes patients are combined with dyslipidemia or hypertension. The clustering of diabetes, obesity, hypertension and dyslipidemia increases the risk of cardiovascular events for patients. GLP-1 (glucagon like peptide-1) is a kind of incretin discovered in recent years. It was reported that beside its hypoglycemic and losing weight effects, activator of GLP-1 receptor could decrease blood pressure and improve lipid metabolism. Therefore, activation of GLP-1 receptor may become a new comprehensive treatment strategies for improving glucose and lipid metabolism, blood pressure level and cardiovascular complication. But, it is lack of evidence-based medicine proof on the relationship between GLP-1 and blood pressure or serum lipid. So, investigators designed a prospective, randomized, open-label, active control study, and try to evaluate the effects of activator of GLP-1 receptor (liraglutide) on lowering blood pressure, improving vascular function and lipid metabolism in overweight or obese type 2 diabetic patients with masked hypertension.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, age between 35-60 years old
- •Type 2 diabetes
- •24kg/m²≤BMI≤32kg/m², or WC≥90cm for male and WC≥85cm for female
- •Grade 1 hypertension or masked hypertension diagnosed via 24-h ambulatory blood pressure monitoring (daytime blood pressure load 50%≥135/85 mmHg, night time blood pressure load 50%≥125/75 mmHg or 24h blood pressure load 50%≥130/80 mmHg）
排除标准
- •Type 2 diabetes with serious complications, such as diabetic neuropathy, diabetic retinopathy, stage IV diabetic nephropathy, or acute diabetic complications.
- •Type 1 diabetes.
- •Diagnosed moderate to severe sleep apnea syndrome(SAS).
- •Grade 2 or Grade 3 hypertension.
- •Triglyceride≥5.65mmol/L
- •History of cardio-cerebral vascular events such as congestive heart failure, myocardial infarction or stroke within 3 months.
- •Hypohepatia (AST or AST is twice higher than the upper limit) or history of hepatitis or cirrhosis, hepatic encephalopathy.
- •Renal insufficiency ( serum creatinine is 1.5 times higher than the upper limit) or history of dialysis and nephritic syndrome.
- •Chronic obstructive pulmonary disease (COPD), chronic respiratory failure or hyoxemia.
- •Acute infections, tumor, severe arrhythmia, mental disorders, alcohol or medicine addiction.
- •Fertile woman without contraceptives.
- •Any surgical or medical conditions that significantly influence absorption, distribution, metabolism or excretion of the intervention drugs.
- •Allergic to or have contraindication to the intervention drugs.
研究组 & 干预措施
"Liraglutide" and "Mitiglinide"
"Liraglutide"(1.2mg/d) and "Mitiglinide"(50mg, 3/d)
干预措施: "Liraglutide" and "Mitiglinide" (Drug)
"Metformin" and "Mitiglinide"
"Metformin"(500mg, 3/d) and "Mitiglinide"(50mg, 3/d)
干预措施: "Metformin" and "Mitiglinide" (Drug)
"Mitiglinide"
"Mitiglinide"(50mg, 3/d)
干预措施: "Mitiglinide" (Drug)
结局指标
主要结局
Blood Pressure change
时间窗: Baseline,4 weeks,8 weeks,12 weeks,16 weeks,20 weeks,up to 24 weeks
Lipid profile (triglyceride, total cholesterol, LDL-c; HDL-c; mmol/L) change
时间窗: Baseline,4 weeks,8 weeks,12 weeks,16 weeks,20 weeks,up to 24 weeks
次要结局
- Hemodynamics parameters, including pulse wave velocity(PWV)(Baseline,4 weeks,8 weeks,12 weeks,16 weeks,20 weeks,up to 24 weeks)
- Carotid intima-media thickness(IMT,mm)(Baseline，12 weeks,up to 24 weeks)
- Obesity parameters, including waist circumference (WC,cm) and body mass index(BMI, kg/m2)(Baseline,4 weeks,8 weeks,12 weeks,16 weeks,20 weeks,up to 24 weeks)
- 24-hours mean blood pressure; incidence of clinical hypertension; Blood pressure variability, Heart rate variability.(Baseline，12 weeks,up to 24 weeks)
- 24-hours urine sodium and microalbumin(Baseline,4 weeks,8 weeks,12 weeks,16 weeks,20 weeks,up to 24 weeks)
- Insulin resistance assessed by fasting serum insulin and HOMA-IR, and control rate of diabetes.(Baseline,4 weeks,8 weeks,12 weeks,16 weeks,20 weeks,up to 24 weeks)
研究者
Yinxing Ni
Medical Doctor
Third Affiliated Hospital of Third Military Medical University