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

July 19, 2015 updated by: Yinxing Ni, Third Affiliated Hospital of Third Military Medical University

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）

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

90

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
24-hours mean blood pressure; incidence of clinical hypertension; Blood pressure variability, Heart rate variability.
Time Frame: Baseline，12 weeks,up to 24 weeks
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
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
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
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
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
Baseline,4 weeks,8 weeks,12 weeks,16 weeks,20 weeks,up to 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Third Affiliated Hospital of Third Military Medical University

Investigators

  • Study Chair: Zhiming Zhu, MD, PHD, The third hospital affiliated to the Third Military Medical University. China

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2015

Primary Completion (ANTICIPATED)

September 1, 2016

Study Completion (ANTICIPATED)

September 1, 2016

Study Registration Dates

First Submitted

May 13, 2015

First Submitted That Met QC Criteria

July 19, 2015

First Posted (ESTIMATE)

July 21, 2015

Study Record Updates

Last Update Posted (ESTIMATE)

July 21, 2015

Last Update Submitted That Met QC Criteria

July 19, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BLOOD

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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