Evaluation of Losartan and Perindopril in Blacks Type 2 Diabetics Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Drug: Perindopril Arginine
* Drug: Losartan Potassium


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: CARE-PLP trial is a double blind, randomized, controlled parallel clinical trial conducted in the National Obesity Center, Yaounde, Cameroon
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Perindopril Arm<br>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<br>* 10 mg Perindopril tablet / day will be added to the usual treatment for each patient for a period of 8 weeks.<br>* Other names: Perindopril;|
| Active Comparator: Losartan Arm<br>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<br>* 100 mg Losartan tablet will be added to the usual treatment for each patient for a period of 08 weeks.<br>* Other names: Losartan;|

What is the study measuring?
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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 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 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 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Angiotensin Converting Enzymes Inhibitor, Angiotensin II Receptor Blockers, Type 2 Diabetes, Exercise induced urinary albumin excretion, Blood pressure