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.

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.

Angiotensin Converting Enzymes Inhibitor, Angiotensin II Receptor Blockers, Type 2 Diabetes, Exercise induced urinary albumin excretion, Blood pressure

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

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.

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.

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.

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.

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

Change in nycthemeral blood pressure profile from baseline to week 08. By using Arterial Blood Pressure Monitoring.

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