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

Primary Purpose

Type 2 Diabetes, Overweight, Obesity

Status

Unknown status

Phase

Phase 4

Locations

Study Type

Interventional

Intervention

"Liraglutide" and "Mitiglinide"

"Metformin" and "Mitiglinide"

"Mitiglinide"

About this trial

This is an interventional treatment trial for Type 2 Diabetes focused on measuring GLP-1, Masked hypertension, Lipid metabolism

Eligibility Criteria

35 Years - 60 Years (Adult)All SexesDoes not accept 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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

"Liraglutide" and "Mitiglinide"

"Metformin" and "Mitiglinide"

"Mitiglinide"

Arm Description

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

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

"Mitiglinide"(50mg, 3/d)

Outcomes

Primary Outcome Measures

Blood Pressure change

Lipid profile (triglyceride, total cholesterol, LDL-c; HDL-c; mmol/L) change

Secondary Outcome Measures

24-hours mean blood pressure; incidence of clinical hypertension; Blood pressure variability, Heart rate variability.

Hemodynamics parameters, including pulse wave velocity(PWV)

24-hours urine sodium and microalbumin

Carotid intima-media thickness(IMT,mm)

Obesity parameters, including waist circumference (WC,cm) and body mass index(BMI, kg/m2)

Insulin resistance assessed by fasting serum insulin and HOMA-IR, and control rate of diabetes.

Full Information

NCT ID

NCT02503943

First Posted

May 13, 2015

Last Updated

July 19, 2015

Sponsor

Third Affiliated Hospital of Third Military Medical University

1. Study Identification

Unique Protocol Identification Number

NCT02503943

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

July 2015

Overall Recruitment Status

Unknown status

Study Start Date

May 2015 (undefined)

Primary Completion Date

September 2016 (Anticipated)

Study Completion Date

September 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Third Affiliated Hospital of Third Military Medical University

4. Oversight

Data Monitoring Committee

Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 2 Diabetes, Overweight, Obesity, Masked Hypertension

Keywords

GLP-1, Masked hypertension, Lipid metabolism

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

"Liraglutide" and "Mitiglinide"

Arm Type

Experimental

Arm Description

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

Arm Title

"Metformin" and "Mitiglinide"

Arm Type

Active Comparator

Arm Description

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

Arm Title

"Mitiglinide"

Arm Type

Active Comparator

Arm Description

"Mitiglinide"(50mg, 3/d)

Intervention Type

Drug

Intervention Name(s)

"Liraglutide" and "Mitiglinide"

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

"Metformin" and "Mitiglinide"

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

"Mitiglinide"

Intervention Description

"Mitiglinide" (50mg, 3/d)

Primary Outcome Measure Information:

Title

Blood Pressure change

Time Frame

Baseline,4 weeks,8 weeks,12 weeks,16 weeks,20 weeks,up to 24 weeks

Title

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 Outcome Measure Information:

Title

24-hours mean blood pressure; incidence of clinical hypertension; Blood pressure variability, Heart rate variability.

Time Frame

Baseline，12 weeks,up to 24 weeks

Title

Hemodynamics parameters, including pulse wave velocity(PWV)

Time Frame

Baseline,4 weeks,8 weeks,12 weeks,16 weeks,20 weeks,up to 24 weeks

Title

24-hours urine sodium and microalbumin

Time Frame

Baseline,4 weeks,8 weeks,12 weeks,16 weeks,20 weeks,up to 24 weeks

Title

Carotid intima-media thickness(IMT,mm)

Time Frame

Baseline，12 weeks,up to 24 weeks

Title

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

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

35 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Zhiming Zhu, MD, PHD

Organizational Affiliation

The third hospital affiliated to the Third Military Medical University. China

Official's Role

Study Chair

12. IPD Sharing Statement

Learn more about this trial

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

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