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

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ClinicalTrials.gov Identifier: NCT02503943
Recruitment Status : Unknown
Verified July 2015 by Yinxing Ni, Third Affiliated Hospital of Third Military Medical University.
Recruitment status was:  Active, not recruiting
First Posted : July 21, 2015
Last Update Posted : July 21, 2015
Sponsor:
Information provided by (Responsible Party):
Yinxing Ni, Third Affiliated Hospital of Third Military Medical University

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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Overweight Obesity Masked Hypertension Drug: "Liraglutide" and "Mitiglinide" Drug: "Metformin" and "Mitiglinide" Drug: "Mitiglinide" Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : May 2015
Estimated Primary Completion Date : September 2016
Estimated Study Completion Date : September 2016

Resource links provided by the National Library of Medicine


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)




Primary Outcome Measures :
  1. Blood Pressure change [ Time Frame: Baseline,4 weeks,8 weeks,12 weeks,16 weeks,20 weeks,up to 24 weeks ]
  2. 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 Measures :
  1. 24-hours mean blood pressure; incidence of clinical hypertension; Blood pressure variability, Heart rate variability. [ Time Frame: Baseline,12 weeks,up to 24 weeks ]
  2. Hemodynamics parameters, including pulse wave velocity(PWV) [ Time Frame: Baseline,4 weeks,8 weeks,12 weeks,16 weeks,20 weeks,up to 24 weeks ]
  3. 24-hours urine sodium and microalbumin [ Time Frame: Baseline,4 weeks,8 weeks,12 weeks,16 weeks,20 weeks,up to 24 weeks ]
  4. Carotid intima-media thickness(IMT,mm) [ Time Frame: Baseline,12 weeks,up to 24 weeks ]
  5. 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 ]
  6. 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 ]


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Ages Eligible for Study:   35 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02503943


Sponsors and Collaborators
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

Responsible Party: Yinxing Ni, Medical Doctor, Third Affiliated Hospital of Third Military Medical University
ClinicalTrials.gov Identifier: NCT02503943     History of Changes
Other Study ID Numbers: BLOOD
First Posted: July 21, 2015    Key Record Dates
Last Update Posted: July 21, 2015
Last Verified: July 2015

Keywords provided by Yinxing Ni, Third Affiliated Hospital of Third Military Medical University:
GLP-1
Masked hypertension
Lipid metabolism

Additional relevant MeSH terms:
Diabetes Mellitus
Hypertension
Overweight
Masked Hypertension
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Vascular Diseases
Cardiovascular Diseases
Body Weight
Signs and Symptoms
Mitiglinide
Metformin
Liraglutide
Incretins
Hypoglycemic Agents
Physiological Effects of Drugs
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists