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

Obesity Clinical Trial

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）

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02503943
• Other study ID #: BLOOD
• Status: Active, not recruiting
• Phase: Phase 4
• First received: May 13, 2015
• Last updated: July 19, 2015
• Start date: May 2015
• Est. completion date: September 2016

Study information

• Verified date: July 2015
• Source: Third Affiliated Hospital of Third Military Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 90
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years to 60 Years

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension
• Masked Hypertension
• Obesity
• Overweight
• Type 2 Diabetes

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Third Affiliated Hospital of Third Military Medical University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood Pressure change		Baseline,4 weeks,8 weeks,12 weeks,16 weeks,20 weeks,up to 24 weeks	No
Primary	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	No
Secondary	24-hours mean blood pressure; incidence of clinical hypertension; Blood pressure variability, Heart rate variability.		Baseline,12 weeks,up to 24 weeks	No
Secondary	Hemodynamics parameters, including pulse wave velocity(PWV)		Baseline,4 weeks,8 weeks,12 weeks,16 weeks,20 weeks,up to 24 weeks	No
Secondary	24-hours urine sodium and microalbumin		Baseline,4 weeks,8 weeks,12 weeks,16 weeks,20 weeks,up to 24 weeks	No
Secondary	Carotid intima-media thickness(IMT,mm)		Baseline,12 weeks,up to 24 weeks	No
Secondary	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	No
Secondary	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	No