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

Sponsor

Yaounde Central Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT04222686

Collaborator

(none)

Enrollment

Location

Arms

4.3

Actual Duration (Months)

5.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Type 2 Diabetes Mellitus	Drug: Perindopril Arginine Drug: Losartan Potassium	Phase 4

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 Design

Study Type:

Interventional

Actual Enrollment :

23 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

CARE-PLP trial is a double blind, randomized, controlled parallel clinical trial conducted in the National Obesity Center, Yaounde, CameroonCARE-PLP trial is a double blind, randomized, controlled parallel clinical trial conducted in the National Obesity Center, Yaounde, Cameroon

Masking:

Double (Participant, Investigator)

Masking Description:

The double-blind model is applied to the study. Only the adjudicator, responsible for the distribution of medication knew the different regimes. Perindopril and Losartan were packaged in boxes of identical appearance and labeled for each participant by name and number of the randomization program. The randomization and packaging of the drugs was done by an investigator who had no clinical involvement.

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Dec 20, 2017

Actual Primary Completion Date :

Feb 15, 2018

Actual Study Completion Date :

Apr 30, 2018

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Variation of exercise-induced urinary albumin excretion [8 weeks]
Variation of exercise-induced urinary albumin excretion (mg/j) between week 0 and week 8. By nephelometry method.

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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