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 (Other)

Overall Status

Unknown status

CT.gov ID

NCT02503943

Collaborator

(none)

Enrollment

Arms

16.1

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Type 2 Diabetes Overweight Obesity Masked Hypertension	Drug: "Liraglutide" and "Mitiglinide" Drug: "Metformin" and "Mitiglinide" Drug: "Mitiglinide"	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

90 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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 Metformin Plus Mitiglinide or Mitiglinide Alone（BLOOD STUDY）

Study Start Date :

May 1, 2015

Anticipated Primary Completion Date :

Sep 1, 2016

Anticipated Study Completion Date :

Sep 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: "Liraglutide" and "Mitiglinide" "Liraglutide"(1.2mg/d) and "Mitiglinide"(50mg, 3/d)	Drug: "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)	Drug: "Metformin" and "Mitiglinide" "Metformin"(500mg, 3/d) and "Mitiglinide"(50mg, 3/d)
Active Comparator: "Mitiglinide" "Mitiglinide"(50mg, 3/d)	Drug: "Mitiglinide" "Mitiglinide" (50mg, 3/d)

Arm

Intervention/Treatment

Experimental: "Liraglutide" and "Mitiglinide"

"Liraglutide"(1.2mg/d) and "Mitiglinide"(50mg, 3/d)

Drug: "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)

Drug: "Metformin" and "Mitiglinide"

"Metformin"(500mg, 3/d) and "Mitiglinide"(50mg, 3/d)

Active Comparator: "Mitiglinide"

"Mitiglinide"(50mg, 3/d)

Drug: "Mitiglinide"

"Mitiglinide" (50mg, 3/d)

Outcome Measures

Primary Outcome Measures

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]

Secondary Outcome Measures

24-hours mean blood pressure; incidence of clinical hypertension; Blood pressure variability, Heart rate variability. [Baseline，12 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]
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) [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]
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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

35 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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）

Exclusion Criteria:

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.