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）
Asset
Liraglutide
Subcutaneous · GLP-1 agonist
Listed sites
0
Recruiting sites
-
Estimated enrollment
90
Study population
Hypertension, Obesity / overweight, Type 2 diabetes
Eligibility highlights
•BMI ≤32
Primary endpoints
•Blood Pressure change•Lipid profile change
Registered trial locations
Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Investigational agents
Who this study enrolls
Who can enroll
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.
Endpoints (8)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Coverage by outcome category
Weight & body composition
1 endpointObesity 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
change from baseline, improvement
componentsWaist circumference, change, BMI, change
Glycemic / diabetes
1 endpointInsulin 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
HOMA-IR (insulin sensitivity)
change from baseline, improvement
Renal / kidney
1 endpoint24-hours urine sodium and microalbumin
Time frame:Baseline,4 weeks,8 weeks,12 weeks,16 weeks,20 weeks,up to 24 weeks
descriptive
Cardiometabolic biomarkers
5 endpointsBlood Pressure change
Time frame:Baseline,4 weeks,8 weeks,12 weeks,16 weeks,20 weeks,up to 24 weeks
change from baseline, improvement
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
change from baseline, improvement
24-hours mean blood pressure; incidence of clinical hypertension; Blood pressure variability, Heart rate variability.
Time frame:Baseline，12 weeks,up to 24 weeks
change from baseline, improvement
componentsMean arterial pressure, Systolic BP, change, Diastolic BP, change, Heart rate, change
Hemodynamics parameters, including pulse wave velocity(PWV)
Time frame:Baseline,4 weeks,8 weeks,12 weeks,16 weeks,20 weeks,up to 24 weeks
change from baseline, improvement
Carotid intima-media thickness(IMT,mm)
Time frame:Baseline，12 weeks,up to 24 weeks
change from baseline, improvement
Provenance
Sources
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 6, 2026 snapshot.