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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| "Liraglutide" and "Mitiglinide" | Experimental | "Liraglutide"(1.2mg/d) and "Mitiglinide"(50mg, 3/d) |
|
| "Metformin" and "Mitiglinide" | Active Comparator | "Metformin"(500mg, 3/d) and "Mitiglinide"(50mg, 3/d) |
|
| "Mitiglinide" | Active Comparator | "Mitiglinide"(50mg, 3/d) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| "Liraglutide" and "Mitiglinide" | Drug | "Liraglutide"(1.2mg/d) and "Mitiglinide" (50mg, 3/d) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Blood Pressure change | 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 | Baseline,4 weeks,8 weeks,12 weeks,16 weeks,20 weeks,up to 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 24-hours mean blood pressure; incidence of clinical hypertension; Blood pressure variability, Heart rate variability. | Baselineļ¼12 weeks,up to 24 weeks | |
| Hemodynamics parameters, including pulse wave velocity(PWV) | Baseline,4 weeks,8 weeks,12 weeks,16 weeks,20 weeks,up to 24 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zhiming Zhu, MD, PHD | The third hospital affiliated to the Third Military Medical University. China | Study Chair |
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| "Metformin" and "Mitiglinide" | Drug | "Metformin"(500mg, 3/d) and "Mitiglinide"(50mg, 3/d) |
|
| "Mitiglinide" | Drug | "Mitiglinide" (50mg, 3/d) |
|
| 24-hours urine sodium and microalbumin | Baseline,4 weeks,8 weeks,12 weeks,16 weeks,20 weeks,up to 24 weeks |
| Carotid intima-media thickness(IMT,mm) | Baselineļ¼12 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 |
| 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 |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D050177 | Overweight |
| D009765 | Obesity |
| D059468 | Masked Hypertension |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000069450 | Liraglutide |
| C087255 | mitiglinide |
| D008687 | Metformin |
| ID | Term |
|---|---|
| D052216 | Glucagon-Like Peptide 1 |
| D004763 | Glucagon-Like Peptides |
| D052336 | Proglucagon |
| D005768 | Gastrointestinal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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