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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

Tracking Information
First Submitted Date  ICMJE May 13, 2015
First Posted Date  ICMJE July 21, 2015
Last Update Posted Date July 21, 2015
Study Start Date  ICMJE May 2015
Estimated Primary Completion Date September 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 19, 2015)
  • Blood Pressure change [ Time Frame: 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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: July 19, 2015)
  • 24-hours mean blood pressure; incidence of clinical hypertension; Blood pressure variability, Heart rate variability. [ Time Frame: 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 ]
  • 24-hours urine sodium and microalbumin [ Time Frame: 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 ]
  • 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 ]
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Incretin on the Blood Pressure and Lipid in Patients With Overweight or Obese Diabetes
Official Title  ICMJE 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)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Type 2 Diabetes
  • Overweight
  • Obesity
  • Masked Hypertension
Intervention  ICMJE
  • Drug: "Liraglutide" and "Mitiglinide"
    "Liraglutide"(1.2mg/d) and "Mitiglinide" (50mg, 3/d)
  • Drug: "Metformin" and "Mitiglinide"
    "Metformin"(500mg, 3/d) and "Mitiglinide"(50mg, 3/d)
  • Drug: "Mitiglinide"
    "Mitiglinide" (50mg, 3/d)
Study Arms  ICMJE
  • Experimental: "Liraglutide" and "Mitiglinide"
    "Liraglutide"(1.2mg/d) and "Mitiglinide"(50mg, 3/d)
    Intervention: Drug: "Liraglutide" and "Mitiglinide"
  • Active Comparator: "Metformin" and "Mitiglinide"
    "Metformin"(500mg, 3/d) and "Mitiglinide"(50mg, 3/d)
    Intervention: Drug: "Metformin" and "Mitiglinide"
  • Active Comparator: "Mitiglinide"
    "Mitiglinide"(50mg, 3/d)
    Intervention: Drug: "Mitiglinide"
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: July 19, 2015)
90
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2016
Estimated Primary Completion Date September 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 35 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02503943
Other Study ID Numbers  ICMJE BLOOD
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Yinxing Ni, Third Affiliated Hospital of Third Military Medical University
Study Sponsor  ICMJE Third Affiliated Hospital of Third Military Medical University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Zhiming Zhu, MD, PHD The third hospital affiliated to the Third Military Medical University. China
PRS Account Third Affiliated Hospital of Third Military Medical University
Verification Date July 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP