Comparison of Aliskiren and Amlodipine on Insulin Resistance and Endothelial Dysfunction in Patients With Hypertension and Metabolic Syndrome
Condition: High Blood Pressure; Metabolic Syndrome; Insulin Resistance; Endothelial Dysfunction
MeSH terms: Hypertension; Metabolic Syndrome; Insulin Resistance; Syndrome
Intervention: Aliskiren; Amlodipine; Placebo Aliskiren; Placebo Amlodipine
Intervention description: Aliskiren 300 mg tablets taken orally once daily; Amlodipine 5 mg capsule taken orally once daily; Placebo Aliskiren taken orally once daily.; Placebo Amlodipine taken orally once daily
Intervention MeSH terms: Amlodipine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 48.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: High Blood pressure; Hypertension; metabolic syndrome; insulin resistance; endothelial dysfunction; pre-diabetic; amlodipine,; aliskiren,; IGT,; IFG,; MBF

Summary:

      The purpose of this study was to determine the effects of Aliskiren on insulin resistance
      (IR) and endothelial dysfunction (ED) in patients with high blood pressure and metabolic
      syndrome. The efficacy of Aliskiren was compared to Amlodipine.
    

Eligibility criteria:

        Inclusion criteria:

          -  Male or female adults aged 18 to 55 years, inclusive.

          -  Sitting diastolic blood pressure ≥80 mm Hg and/or sitting systolic blood pressure ≥
             130 at screening.

          -  Metabolic Syndrome as defined by the Adult Treatment Panel (ATP) III criteria.

          -  Hypertension (defined above) and impaired glucose tolerance (IGT) or impaired fasting
             glucose (IFG) plus one or more out of the remaining 3 criteria to satisfy entry into
             the study. IGT and IFG will be classified according to American Diabetes Association
             (ADA) guidelines:

               -  IFG: Fasting plasma glucose of 100 mg/dl (5.6 mmol/l) to 125 mg/dl (6.9 mmol/l)

               -  IGT: Two-hour plasma glucose of 140 mg/dl (7.8 mmol/l) to 199 mg/dl (11.0 mmol/l)

          -  Abnormal Positron Emission Tomography (PET) results at baseline. (Myocardial Blood
             Flow (MBF) of less than or equal to 35%.)

          -  Abnormal euglycemic clamp results at baseline. (Glucose infusion rate (GINF) of less
             than or equal to 4.2 mg/kg/min.)

          -  Body mass index (BMI) of less than 40.

        Exclusion criteria:

          -  Smokers (use of tobacco products in the recent past)

          -  Cardiovascular abnormalities including myocardial infarction, angina pectoris,
             hypertensive encephalopathy, stroke, transient ischemic attack, valvular heart
             disease, ventricular arrhythmia, A-V block, atrial fibrillation or cardiac
             revascularization/angioplasty in the past 12 months.

          -  Symptoms or clinical evidence of congestive heart failure or known left ventricular
             ejection fraction < 40%.

          -  Supine Blood pressure ≥ 160 mmHg systolic or ≥110 mmHg diastolic.

          -  Clinically significant echocardiogram (ECG) abnormalities, including history of a
             prolonged QT-interval syndrome.

          -  Significant autonomic dysfunction.

          -  Severe bronchospastic disease (including asthma and chronic obstructive pulmonary
             disease, treated or not treated).

          -  Clinically significant drug allergy, atopic allergy (asthma, urticaria, eczematous
             dermatitis).

          -  Pregnant or breastfeeding females. Pre-menopausal females who are not practicing a
             non-hormonal method of birth control.

          -  African Americans will not be eligible for this study.

        Other protocol-defined inclusion/exclusion criteria may apply.