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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
23
10 mg Perindopril tablet / day will be added to the usual treatment for each patient for a period of 8 weeks.
100 mg Losartan tablet will be added to the usual treatment for each patient for a period of 08 weeks.
Yaounde Central Hospital, NAtional Obesity Center
Yaoundé, Cameroon
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.
Time frame: 8 weeks
Change in rest urinary albumin excretion
Change in rest urinary albumin excretion (mg/l) from baseline to week 08. By nephelometry method.
Time frame: 8 weeks
Change in mitral E/Ea ratio
Change in mitral E/Ea ratio from baseline to week 08. By tissue doppler on echocardiography.
Time frame: 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.
Time frame: 8 weeks
Change in concentration of antioxidants markers (micromol)
Change in concentration of antioxidants markers from baseline to week 08. By spectrophotometer
Time frame: 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
Time frame: 8 weeks
Change in uricemia concentration
Change in uricemia concentration (mg/l) from baseline to week 08. By spectrophotometer
Time frame: 8 weeks
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