Clinical Trial: Effects of Incretin on the Blood Pressure and Lipid in Patients With Overweight or Obese Diabetes

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: 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 M

Brief Summary: 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.

Detailed Summary:
Sponsor: Third Affiliated Hospital of Third Military Medical University

Current Primary Outcome:

  • Blood Pressure change [ Time Frame: 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 [ Time Frame: Baseline,4 weeks,8 weeks,12 weeks,16 weeks,20 weeks,up to 24 weeks ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 24-hours mean blood pressure; incidence of clinical hypertension; Blood pressure variability, Heart rate variability. [ Time Frame: Baseline，12 weeks,up to 24 weeks ]
  • Hemodynamics parameters, including pulse wave velocity(PWV) [ Time Frame: Baseline,4 weeks,8 weeks,12 weeks,16 weeks,20 weeks,up to 24 weeks ]
  • 24-hours urine sodium and microalbumin [ Time Frame: Baseline,4 weeks,8 weeks,12 weeks,16 weeks,20 weeks,up to 24 weeks ]
  • Carotid intima-media thickness(IMT,mm) [ Time Frame: Baseline，12 weeks,up to 24 weeks ]
  • Obesity parameters, including waist circumference (WC,cm) and body mass index(BMI, kg/m2) [ Time Frame: 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. [ Time Frame: Baseline,4 weeks,8 weeks,12 weeks,16 weeks,20 weeks,up to 24 weeks ]


Original Secondary Outcome: Same as current

Information By: Third Affiliated Hospital of Third Military Medical University

Dates:
Date Received: May 13, 2015
Date Started: May 2015
Date Completion: September 2016
Last Updated: July 19, 2015
Last Verified: July 2015