Effect of Morning Versus Evening Perindopril on Blood Pressure Control in People With Type 2 Diabetes (CHRONIC1)

Yaounde Central Hospital

Status and phase: Completed; Phase 4

Conditions: Hypertension; Diabetes Mellitus, Type 2

Treatments: Drug: Perindopril Oral Tablet

Study type: Interventional

Funder types: Other

Identifiers

NCT03393715

CNO20162

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Perindopril morning

Experimental group

Description:

10 mg of perindopril oral tablet once daily in the morning for 56 days

Treatment:

Drug: Perindopril Oral Tablet

Perindopril evening

Active Comparator group

Description:

10 mg of perindopril oral tablet once daily in the evening for 56 days

Treatment:

Drug: Perindopril Oral Tablet