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

NCT ID: NCT03393715

Last Updated: 2018-01-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-02-29
• Study Completion Date: 2016-08-31

Brief Summary

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

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.

Conditions

Diabetes Mellitus, Type 2; Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Perindopril morning

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

Group Type: EXPERIMENTAL

Perindopril Oral Tablet

Intervention Type: DRUG

Perindopril oral tablet morning versus evening

Perindopril evening

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

Group Type: ACTIVE_COMPARATOR

Perindopril Oral Tablet

Intervention Type: DRUG

Perindopril oral tablet morning versus evening

Interventions

Perindopril Oral Tablet

Perindopril oral tablet morning versus evening

Intervention Type: DRUG

Other Intervention Names

Coversyl 10 mg

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Yaounde 1

OTHER

Sponsor Role: collaborator

Yaounde Central Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Sobngwi Eugene

Professor of Endocrinology and Diabetes

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Eugène Sobngwi, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Yaounde Central Hospital

Other Identifiers

CNO20162

Identifier Type: -

Identifier Source: org_study_id