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

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: July 2016

Detailed Description

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.

Interventions

  • Drug: Perindopril Oral Tablet
    • Perindopril oral tablet morning versus evening

Arms, Groups and Cohorts

  • Experimental: Perindopril morning
    • 10 mg of perindopril oral tablet once daily in the morning for 56 days
  • Active Comparator: Perindopril evening
    • 10 mg of perindopril oral tablet once daily in the evening for 56 days

Clinical Trial Outcome Measures

Primary Measures

  • 24-hour blood pressure profile
    • Time Frame: 56 days
    • Overall blood pressure control

Secondary Measures

  • Night time blood pressure dip
    • Time Frame: 56 days
    • Blood pressure drop at night

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Yaounde Central Hospital
  • Collaborator
    • University of Yaounde 1
  • Provider of Information About this Clinical Study
    • Principal Investigator: Sobngwi Eugene, Professor of Endocrinology and Diabetes – Yaounde Central Hospital
  • Overall Official(s)
    • Eugène Sobngwi, MD, PhD, Principal Investigator, Yaounde Central Hospital

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