Irbesartan Versus Amlodipine: The OBI Study

Study Overview
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Brief Summary
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Objective: To study the effectiveness of irbesartan 300mg and amlodipine 10 mg in 24h ambulatory blood pressure values in obese subjects To study the drug specific effect in arterial stiffness To study possible drug mechanisms in obesity (reduction of central adiposity and changing the ratio of leptin to adiponectin)

Detailed Description
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Study Objectives Primary: Reduction of 24h BP in obese hypertensives Reduction in arterial stiffness Secondary Drug specific effect on new onset of diabetes Drug specific effect on reduction in central fat deposition and the leptin to adiponectin ratio Study design Study drugs: Irbesartan 300mg vs. amlodipine 10mg Tx duration and follow-up: 12 months Collected data: 24h SBP and DBP in time 0, 1, 12. Pulse wave velocity in time 0,1,12. Central obesity (total, visceral, abdominal fat) in time 0,1,12. Leptin/adiponectin in time 0,1,12. BMI, waist/hip ratio in time 0,1, 12. Glu, HbA1c, insulin in time 0, 1,12. K, Na, Cr, BUN, Chol, Tg, HDL, LDL,ALT, AST in time 0, 1,12. Number of patients: The reduction in mean SBP expected to be 15 mmHg. Previous studies from our group reported an 14mmHg SD for mean SBP. The sample size required at the two sided 5% significance level and 80% power is 40 patients (Lehr's formula) Number of centers: 1

Official Title
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Double Blind Study of Irbesartan vs. Amlodipine in Obese Hypertensive Subjects- The OBI Study

Conditions
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Obesity, Hypertension

Intervention / Treatment
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* Drug: Irbesartan
* Drug: Amlodipine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age between 18 and 60 years. All patients are going to give their informed consent to participate in the study. Stage I hypertension. BMI > 30. Exclusion Criteria: Known oversensitiveness, Chronic renal disease (GFR < 50 ml/min) or ESRD, Heart or respiratory failure, OR Recent MI, shock, liver deficiency (ALT or AST > 3 times normal and pregnancy or lactation.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Irbesartan<br>Treatment with irbesartan 300mg for 4 weeks. IF ABP>135/85 mmHg add HCZ 12.5 mg. | Drug: Irbesartan<br>* Treatment with irbesartan 300mg for 4 weeks. IF ABP>135/85 mmHg add hydrochlorothiazide 12.5 mg.<br>|
| Active Comparator: Amplodipine<br>Treatment with amlodipine 10 mg for 4 weeks. If BP>135/85 mmHg add hydrochlorothiazide 12.5 mg | Drug: Amlodipine<br>* Treatment with amlodipine 10 mg for 4 weeks. If ABP>135/85 mmHg add hydrochlorothiazide 12.5 mg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of 24h BP and arterial stiffness in obese hypertensives |  | 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| New onset of diabetes |  | 12 | 
| Drug specific effect on reduction in central fat deposition and the leptin to adiponectin ratio |  | 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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irbesartan, amlodipine, obesity, ambulatory blood pressure monitoring, new onset diabetes