Effect of Morning Versus Evening Perindopril on Blood Pressure Control in People With Type 2 Diabetes

Study Overview
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Brief Summary
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We assessed the influence of time of administration of ACE inhibitors on circadian blood pressure control in sub Saharan type 2 diabetes patients with stage 1 hypertension over 56 days as first line treatment.

Detailed Description
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Background: Renin-angiotensin system antagonists represent the mainstay of blood pressure (BP) lowering treatment options in people with diabetes. ACE inhibitors have a long half-life and offer the advantage of a single daily dose, usually empirically taken in the morning. Objective: We assessed the influence of time of administration of ACE inhibitors on circadian BP control in type 2 diabetes (T2D) patients with stage 1 hypertension. Methods: Twenty T2D patients (9 being women) with a mean age of 58.7 years, diagnosed with stage 1 of hypertension and naive to BP lowering medications, were included. They were randomly allocated to receive perindopril 10 mg/day as a monotherapy either in the morning or in the evening for 28 days, with crossover without washout period on day 29th and additional 28 days follow-up. A 24-hour ambulatory BP monitoring (ABPM) was performed at baseline, days 28 and 56.

Official Title
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Effect of Morning Versus Evening Perindopril on Blood Pressure Control in People With Type 2 Diabetes

Conditions
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Diabetes Mellitus, Type 2, Hypertension

Intervention / Treatment
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* Drug: Perindopril Oral Tablet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Type 2 diabetes Grade 1 hypertension Informed consent Exclusion Criteria: estimated creatinine clearance≤ 60ml/min White coat hypertension after initial 24 hour ABPM Previous antihypertensive treatment Pregnant women Individuals working during the night Hyperkalemia

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: open label randomised controlled trial with crossover of perindopril administered in the morning versus evening on blood pressure control
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Perindopril morning<br>10 mg of perindopril oral tablet once daily in the morning for 56 days | Drug: Perindopril Oral Tablet<br>* Perindopril oral tablet morning versus evening<br>* Other names: Coversyl 10 mg;|
| Active Comparator: Perindopril evening<br>10 mg of perindopril oral tablet once daily in the evening for 56 days | Drug: Perindopril Oral Tablet<br>* Perindopril oral tablet morning versus evening<br>* Other names: Coversyl 10 mg;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 24-hour blood pressure profile | Overall blood pressure control | 56 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Night time blood pressure dip | Blood pressure drop at night | 56 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Perindopril, Diabetes, Hypertension, chronobiology, Africa