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

Sponsor
Third Affiliated Hospital of Third Military Medical University
Study ID
NCT02503943
Phase
PHASE4
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
35 Years - 60 Years
Healthy Volunteers
Not accepted

Interventions

  • "Liraglutide" and "Mitiglinide" — DRUG
    "Liraglutide"(1.2mg/d) and "Mitiglinide" (50mg, 3/d)
  • "Metformin" and "Mitiglinide" — DRUG
    "Metformin"(500mg, 3/d) and "Mitiglinide"(50mg, 3/d)
  • "Mitiglinide" — DRUG
    "Mitiglinide" (50mg, 3/d)

Study Details

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.

Key Dates

Start date
May 31, 2015
Status verified
Jul 2015
Primary completion
Sep 30, 2016
Completion
Sep 30, 2016

Study Design

Enrollment
90 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: "Liraglutide" and "Mitiglinide"
    "Liraglutide"(1.2mg/d) and "Mitiglinide"(50mg, 3/d)
  • Active Comparator: "Metformin" and "Mitiglinide"
    "Metformin"(500mg, 3/d) and "Mitiglinide"(50mg, 3/d)
  • Active Comparator: "Mitiglinide"
    "Mitiglinide"(50mg, 3/d)

Primary Outcome Measure

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

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