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Pleiotropic Effects of Azilsartan Medoxomil Over Insulin Resistance in Obese, Diabetic and Hypertensive Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02235519
Recruitment Status : Unknown
Verified September 2014 by Hospital General de México Dr. Eduardo Liceaga.
Recruitment status was:  Recruiting
First Posted : September 10, 2014
Last Update Posted : March 30, 2015
Information provided by (Responsible Party):
Hospital General de México Dr. Eduardo Liceaga

Brief Summary:
The goal of this study is to build a mathematical model to explain the effect of two doses of azilsartan (40 and 80 mg) upon metabolic (insulin resistance, glucose) and inflammatory parameters (cytokines) in function of "metabolic strata" like obesity, type 2 diabetes mellitus, hypertension and their combinations.

Condition or disease Intervention/treatment Phase
Hypertension Obesity Type 2 Diabetes Mellitus Drug: Azilsartan 40 mg. Drug: Azilsartan 80 mg Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Open Label Study to Evaluate the Pleiotropic Effects of Azilsartan Medoxomil 40 and 80 mg for 12 Weeks Over Metabolic Markers in Patients With Hypertension, Obesity or Type 2 Diabetes Mellitus
Study Start Date : January 2014
Estimated Primary Completion Date : June 2015
Estimated Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Azilsartan low dosage
Patients will take azilsartan 40 mg during 12 weeks
Drug: Azilsartan 40 mg.
Patients will take 40 mg of azilsartan during 12 weeks
Other Name: Edarbi 40 mg

Active Comparator: Azilsartan high dosage
Patients will take azilsartan 80 mg during 12 weeks
Drug: Azilsartan 80 mg
Patients will take 80 mg of azilsartan during 12 weeks
Other Name: Edarbi 80 mg

Primary Outcome Measures :
  1. Blood pressure [ Time Frame: 12 weeks ]
    Effect size of azilsartan medoxomil 40 and 80 mg in lowering systolic and diastolic blood pressure stratified by metabolic condition (obesity or type 2 diabetes mellitus). The minimal size effect between groups will be at least 30% and absolute percentage of previous hypertensive subjects reaching targeted values of < 130/85 mmHg.

Secondary Outcome Measures :
  1. Insulin sensitivity and HbA1c level [ Time Frame: 12 weeks ]
    Effect over insulin sensitivity measured by Matsuda index of insulin sensitivity (ISI) and the level of HbA1c. The function will show a increase for ISI that in a within contrast will be larger for those with obesity with hypertension and diabetes. Meanwhile the HbA1 will show a deep decrease for the same group.

  2. Effect of azilsartan on Inflammatory markers [ Time Frame: 12 weeks ]
    Effect size between azilsartan 40 mg and 80 mg on inflammatory markers (IL-1b, IL-6, IL 10, TNF-α, and adiponectin). A decrease in this response will be more important for the 80 mg and those with obesity, hipertension and diabetes.

  3. Endothelial function [ Time Frame: 12 weeks ]
    Subjects with stiffness of the carotid and brachial artery will show improvement in relaxation, and the larger effect will be for 80 mg in the group of obesity, hypertension and diabetes mellitus.

  4. Renal function improvement. [ Time Frame: 12 weeks ]
    Proteinuria will show a significant decrease after 12 weeks of treatment with azilsartan. The larger effect will be for the 80 mg and the obese, hypertension and diabetic group.

Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  1. Written informed consent in accordance with Good Clinical Practices and local legislations
  2. Age between ≥25 and ≤ 65 years
  3. Patients with hypertension stage 1 as defined by systolic blood pressure (SBP) ≥140 but <159 mmHg and diastolic blood pressure (DBP) ≥90 but < 99 mmHg at randomization
  4. Ability to stop any current antihypertensive therapy without unacceptable risk to the patient (Investigator's discretion)
  5. BMI ≥25 and ≤35.
  6. Patients with type 2 diabetes mellitus can participate and will be stratified before randomization. Diagnosis can be established by clinical history, 75-g oral glucose tolerance test (ADA criteria), or fasting glucose > 126 mg/dL.

Exclusion Criteria:

  1. Pre-menopausal women (last menstruation ≤1 year prior to signing informed consent) who are not surgically sterile, nursing, are pregnant or without any anticonceptive methods.
  2. Known hypersensitivity to the study drug
  3. Gastrointestinal surgery which might alter absorption, distribution, or drug metabolism.
  4. History of angioedema related to ACE inhibitors or angiotensin II receptor blockers.
  5. Night shift workers who routinely sleep during the daytime and whose work hours include midnight to 4:00 a.m.
  6. Known or suspected secondary hypertension (e.g., renal artery stenosis or phaeochromocytoma)
  7. SBP≥160 mmHg and/or DBP ≥100 mmHg
  8. Renal dysfunction as defined by: serum creatinine >3.0 mg/dL (or >265 umol/L) and/or creatinine clearance <30 ml/min and/or other clinical markers of severe renal impairment.
  9. Bilateral renal arterial stenosis, renal artery stenosis in a solitary functional kidney, post-renal transplant patients or patients with one kidney
  10. Clinically relevant hypokalemia or hyperkalemia (i.e., <3.5 mmol/L or >5.5 mmol/L, may be rechecked for suspected error in result)
  11. Uncorrected sodium or volume depletion
  12. Primary aldosteronism.
  13. Hereditary fructose intolerance
  14. Biliary obstructive disorders (e.g., cholestasis) or hepatic insufficiency
  15. Congestive heart failure class III-IV according to criteria fron the New York Heart Association.
  16. Clinically significant ventricular tachycardia, atrial fibrillation, atrial flutter or other clinically relevant cardiac arrhythmias as determined by the Investigator.
  17. Hypertrophic obstructive cardiomyopathy, severe obstructive coronary artery disease, aortic stenosis, hemodynamically relevant stenosis of the aortic or mitral valve
  18. Patients whose diabetes has not been stable and controlled for at least the past 3 months as defined by an Glycosylated Hemoglobin A1c >=10% or fasting glucose greater than 400 mg/dL.
  19. Patients who have previously experienced symptoms characteristic of angioedema during treatment with ACE inhibitors or angiotensin-II receptor antagonists
  20. History of drug or alcohol dependency within 6 months prior to signing the informed consent form
  21. Concomitant administration of any medications known to affect blood pressure, except medications allowed by the protocol
  22. Any investigational drug therapy within 1 month of signing the informed consent
  23. Known hypersensitivity to any component of the trial drugs (telmisartan, hydrochlorothiazide, or placebo)
  24. History of non-compliance or inability to comply with prescribed medications or protocol procedures (less than 80% or more than 120%, especially during run-in).
  25. Any other clinical condition which, in the opinion of the investigator, would not allow safe completion of the protocol and safe administration of the trial medication

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 identifier (NCT number): NCT02235519

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Contact: Antonio Peralta, MD 521(55)43466306

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Hospital General de Mexico "Dr. Eduardo Liceaga" Recruiting
Mexico, Mexico, D.F., Mexico, 06720
Contact: Juan A Peralta, bachelor         
Sponsors and Collaborators
Hospital General de México Dr. Eduardo Liceaga
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Principal Investigator: Antonio Peralta, MD HGM
Study Chair: Rogelio Zapata, MD HGM
Study Director: Estrella Martinez, RN HGM
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Responsible Party: Hospital General de México Dr. Eduardo Liceaga Identifier: NCT02235519    
Other Study ID Numbers: DI/12/404B/4/85
First Posted: September 10, 2014    Key Record Dates
Last Update Posted: March 30, 2015
Last Verified: September 2014
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Nutrition Disorders
Body Weight
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Vascular Diseases
Cardiovascular Diseases
Azilsartan medoxomil
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action