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

NCT02235519 | Unknown Phase 2 DMC

• 1 other identifier: DI/12/404B/4/85
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension; Obesity; Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Blood pressure

  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.

  12 weeks

Secondary Outcomes (4)

• Insulin sensitivity and HbA1c level

  12 weeks

• Effect of azilsartan on Inflammatory markers

  12 weeks

• Endothelial function

  12 weeks

• Renal function improvement.

  12 weeks

Study Arms (2)

Azilsartan low dosage

ACTIVE COMPARATOR

Patients will take azilsartan 40 mg during 12 weeks

Drug: Azilsartan 40 mg.

Azilsartan high dosage

ACTIVE COMPARATOR

Patients will take azilsartan 80 mg during 12 weeks

Drug: Azilsartan 80 mg

Interventions

Azilsartan 40 mg. DRUG

Patients will take 40 mg of azilsartan during 12 weeks

Also known as: Edarbi 40 mg

Azilsartan low dosage

Azilsartan 80 mg DRUG

Patients will take 80 mg of azilsartan during 12 weeks

Also known as: Edarbi 80 mg

Azilsartan high dosage

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent in accordance with Good Clinical Practices and local legislations
• Age between ≥25 and ≤ 65 years
• 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
• Ability to stop any current antihypertensive therapy without unacceptable risk to the patient (Investigator's discretion)
• BMI ≥25 and ≤35.
• 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.

You may not qualify if:

• 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.
• Known hypersensitivity to the study drug
• Gastrointestinal surgery which might alter absorption, distribution, or drug metabolism.
• History of angioedema related to ACE inhibitors or angiotensin II receptor blockers.
• Night shift workers who routinely sleep during the daytime and whose work hours include midnight to 4:00 a.m.
• Known or suspected secondary hypertension (e.g., renal artery stenosis or phaeochromocytoma)
• SBP≥160 mmHg and/or DBP ≥100 mmHg
• 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.
• Bilateral renal arterial stenosis, renal artery stenosis in a solitary functional kidney, post-renal transplant patients or patients with one kidney
• Clinically relevant hypokalemia or hyperkalemia (i.e., \<3.5 mmol/L or \>5.5 mmol/L, may be rechecked for suspected error in result)
• Uncorrected sodium or volume depletion
• Primary aldosteronism.
• Hereditary fructose intolerance
• Biliary obstructive disorders (e.g., cholestasis) or hepatic insufficiency
• Congestive heart failure class III-IV according to criteria fron the New York Heart Association.

Sponsors & Collaborators

• Hospital General de México Dr. Eduardo Liceaga: lead

Study Sites (1)

Hospital General de Mexico "Dr. Eduardo Liceaga"

Mexico City, Mexico City, 06720, Mexico

RECRUITING

MeSH Terms

Conditions

Hypertension; Obesity; Diabetes Mellitus, Type 2

Interventions

azilsartan

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

Study Officials

• Antonio Peralta, MD

  HGM

  PRINCIPAL INVESTIGATOR

• Rogelio Zapata, MD

  HGM

  STUDY CHAIR

• Estrella Martinez, RN

  HGM

  STUDY DIRECTOR

Central Study Contacts

Antonio Peralta, MD

CONTACT

521(55)43466306; juan_peca@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2014
• First Posted: September 10, 2014
• Study Start: January 1, 2014
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: March 30, 2015

Record last verified: 2014-09

Locations

ME (1)