Overview

This trial is active, not recruiting.

Conditions type 2 diabetes, overweight, obesity, masked hypertension
Treatments "liraglutide" and "mitiglinide", "metformin" and "mitiglinide", "mitiglinide"
Phase phase 4
Sponsor Third Affiliated Hospital of Third Military Medical University
Start date May 2015
End date September 2016
Trial size 90 participants
Trial identifier NCT02503943, BLOOD

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
"Liraglutide"(1.2mg/d) and "Mitiglinide"(50mg, 3/d)
"liraglutide" and "mitiglinide"
"Liraglutide"(1.2mg/d) and "Mitiglinide" (50mg, 3/d)
(Active Comparator)
"Metformin"(500mg, 3/d) and "Mitiglinide"(50mg, 3/d)
"metformin" and "mitiglinide"
"Metformin"(500mg, 3/d) and "Mitiglinide"(50mg, 3/d)
(Active Comparator)
"Mitiglinide"(50mg, 3/d)
"mitiglinide"
"Mitiglinide" (50mg, 3/d)

Primary Outcomes

Measure
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

Secondary Outcomes

Measure
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

Eligibility Criteria

Male or female participants from 35 years up to 60 years old.

Inclusion Criteria: 1. Male or female, age between 35-60 years old 2. Type 2 diabetes 3. 24kg/m²≤BMI≤32kg/m², or WC≥90cm for male and WC≥85cm for female 4. 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: 1. Type 2 diabetes with serious complications, such as diabetic neuropathy, diabetic retinopathy, stage IV diabetic nephropathy, or acute diabetic complications. 2. Type 1 diabetes. 3. Diagnosed moderate to severe sleep apnea syndrome(SAS). 4. Grade 2 or Grade 3 hypertension. 5. Triglyceride≥5.65mmol/L 6. History of cardio-cerebral vascular events such as congestive heart failure, myocardial infarction or stroke within 3 months. 7. Hypohepatia (AST or AST is twice higher than the upper limit) or history of hepatitis or cirrhosis, hepatic encephalopathy. 8. Renal insufficiency ( serum creatinine is 1.5 times higher than the upper limit) or history of dialysis and nephritic syndrome. 9. Chronic obstructive pulmonary disease (COPD), chronic respiratory failure or hyoxemia. 10. Acute infections, tumor, severe arrhythmia, mental disorders, alcohol or medicine addiction. 11. Fertile woman without contraceptives. 12. Any surgical or medical conditions that significantly influence absorption, distribution, metabolism or excretion of the intervention drugs. 13. Allergic to or have contraindication to the intervention drugs.

Additional Information

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)
Trial information was received from ClinicalTrials.gov and was last updated in July 2015.
Information provided to ClinicalTrials.gov by Third Affiliated Hospital of Third Military Medical University.