Evaluation of Losartan and Perindopril in Blacks Type 2 Diabetics Patients (CARE-PLP)

Rationale and Design of a Simple Randomized Trial Evaluating Losartan and Perindopril in Blacks Type 2 Diabetics Patients: the Cardiac and Renal Protection With Losartan or Perindopril (CARE-PLP) Trial

The aim of this study is to compare the short-term effects of ACEi and angiotensin II receptor blockers on cardiac and renal protection in black type 2 diabetics patients CARE-PLP is a double-arm, double-blind, randomized and parallel clinical trial conducted at the National Obesity Center in the Yaoundé Central Hospital. A population of Type 2 diabetes patients, with hypertension and / or microalbuminuria and who are not taking ACEi or angiotensin receptors blockers, is randomize into two groups. Depending on the group, 10 mg Perindopril or 100 mg Losartan is add to the usual treatment for each patient. The patients are followed-up for a period of 08 weeks. The primary outcome is the variation of exercise induced urinary albumin excretion after 08 weeks of intervention.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes Mellitus
• Intervention / Treatment: Drug: Perindopril Arginine; Drug: Losartan Potassium

Detailed Description

Given the particularity of the renin-angiotensin system in black subjects, the CARE-PLP study fulfills this objective with the comparison of Losartan and Perindopril after 08 weeks of administration in a subsaharan African population.

Aim: The aim of this study is to compare the short-term effects of ACEi and angiotensin II receptor blockers on cardiac and renal protection in black type 2 diabetics patients

Methods: CARE-PLP is a double-arm, double-blind, randomized and parallel clinical trial conducted at the National Obesity Center in the Yaoundé Central Hospital. A population of Type 2 diabetes patients, with hypertension and / or microalbuminuria and who are not taking ACEi or angiotensin receptors blockers, is randomize into two groups. Depending on the group, 10 mg Perindopril or 100 mg Losartan is add to the usual treatment for each patient. The patients are followed-up for a period of 08 weeks. The primary outcome is the variation of exercise induced urinary albumin excretion after 08 weeks of intervention.

Progress: Recruitment for CARE-PLP was completed in february 2018 with 29 patients.

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Phase 4

Contacts and Locations

Study Locations

• Cameroon
  • Yaounde, Cameroon
    • Yaounde Central Hospital, NAtional Obesity Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Type 2 Diabetics subjects
• Urinary albumin excretion >30 g/day or Blood pressure > 140/90
• On a stable antidiabetic and antihypertensive therapies (determined by the investigator) for at least 3 months with no classes changes. The pharmacological treatment should not include an angiotensin-converting enzyme inhibitor or angiotensin II receptor blocker
• Subject must not present any contraindication to exercise
• Before any study-specific procedure, the appropriate written informed consent must be obtained.

Exclusion Criteria:

• Side effects affecting life quality of patients (determined by the Data Safety Monitoring Board).
• Signs of exercise intolerance
• Out of sight.
• Withdrawal of consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Perindopril Arm; 10 mg Perindopril tablet per day at 8am (+/- 1 hour) was add to the usual treatment for each patient. Patients are followed-up for a period of 08 weeks.	Drug: Perindopril Arginine; 10 mg Perindopril tablet / day will be added to the usual treatment for each patient for a period of 8 weeks.; Other Names: Perindopril
Active Comparator: Losartan Arm; 100 mg Losartan tablet per day at 8am (+/- 1 hour) was add to the usual treatment for each patient. Patients are followed-up for a period of 08 weeks.	Drug: Losartan Potassium; 100 mg Losartan tablet will be added to the usual treatment for each patient for a period of 08 weeks.; Other Names: Losartan

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Variation of exercise-induced urinary albumin excretion	Variation of exercise-induced urinary albumin excretion (mg/j) between week 0 and week 8. By nephelometry method.	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in nycthemeral blood pressure profile (mmHg)	Change in nycthemeral blood pressure profile from baseline to week 08. By using Arterial Blood Pressure Monitoring.	8 weeks
Change in rest urinary albumin excretion	Change in rest urinary albumin excretion (mg/l) from baseline to week 08. By nephelometry method.	8 weeks
Change in mitral E/Ea ratio	Change in mitral E/Ea ratio from baseline to week 08. By tissue doppler on echocardiography.	8 weeks
Change in concentration of antioxidants markers (micromol)	Change in concentration of antioxidants markers from baseline to week 08. By spectrophotometer	8 weeks
Change in lipid profile (triglycerides, Total cholesterol, HDL-cholesterol, LDL-cholesterol) on g/l	Change in lipid profile from baseline to week 08. By spectrophotometer	8 weeks
Change in uricemia concentration	Change in uricemia concentration (mg/l) from baseline to week 08. By spectrophotometer	8 weeks

Collaborators and Investigators

• Sponsor: Yaounde Central Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 20, 2017
• Primary Completion (Actual): February 15, 2018
• Study Completion (Actual): April 30, 2018

Study Registration Dates

• First Submitted: April 8, 2019
• First Submitted That Met QC Criteria: January 6, 2020
• First Posted (Actual): January 10, 2020

Study Record Updates

• Last Update Posted (Actual): January 10, 2020
• Last Update Submitted That Met QC Criteria: January 6, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: Type 2 Diabetes; Blood pressure; Angiotensin II Receptor Blockers; Angiotensin Converting Enzymes Inhibitor; Exercise induced urinary albumin excretion
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Antihypertensive Agents; Enzyme Inhibitors; Protease Inhibitors; Angiotensin II Type 1 Receptor Blockers; Angiotensin Receptor Antagonists; Angiotensin-Converting Enzyme Inhibitors; Losartan; Perindopril
• Other Study ID Numbers: CARE-PLP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No