Effects of Incretin on the Blood Pressure and Lipid in Patients With Overweight or Obese Diabetes
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）
1 other identifier
interventional
90
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4 type-2-diabetes
Started May 2015
Shorter than P25 for phase_4 type-2-diabetes
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2015
CompletedFirst Submitted
Initial submission to the registry
May 13, 2015
CompletedFirst Posted
Study publicly available on registry
July 21, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2016
CompletedJuly 21, 2015
July 1, 2015
1.3 years
May 13, 2015
July 19, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (6)
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
- +1 more secondary outcomes
Study Arms (3)
"Liraglutide" and "Mitiglinide"
EXPERIMENTAL"Liraglutide"(1.2mg/d) and "Mitiglinide"(50mg, 3/d)
"Metformin" and "Mitiglinide"
ACTIVE COMPARATOR"Metformin"(500mg, 3/d) and "Mitiglinide"(50mg, 3/d)
"Mitiglinide"
ACTIVE COMPARATOR"Mitiglinide"(50mg, 3/d)
Interventions
"Liraglutide"(1.2mg/d) and "Mitiglinide" (50mg, 3/d)
"Metformin"(500mg, 3/d) and "Mitiglinide"(50mg, 3/d)
Eligibility Criteria
You may qualify if:
- Male or female, age between 35-60 years old
- Type 2 diabetes
- kg/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）
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Zhiming Zhu, MD, PHD
The third hospital affiliated to the Third Military Medical University. China
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Medical Doctor
Study Record Dates
First Submitted
May 13, 2015
First Posted
July 21, 2015
Study Start
May 1, 2015
Primary Completion
September 1, 2016
Study Completion
September 1, 2016
Last Updated
July 21, 2015
Record last verified: 2015-07