Evaluation of Losartan and Perindopril in Blacks Type 2 Diabetics Patients
- Conditions
- Type 2 Diabetes Mellitus
- Interventions
- Registration Number
- NCT04222686
- Lead Sponsor
- Yaounde Central Hospital
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 23
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Perindopril Arm Perindopril Arginine 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. Losartan Arm Losartan Potassium 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.
- Primary Outcome Measures
Name Time Method 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
Name Time 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 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 rest urinary albumin excretion 8 weeks Change in rest urinary albumin excretion (mg/l) from baseline to week 08. By nephelometry method.
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 uricemia concentration 8 weeks Change in uricemia concentration (mg/l) from baseline to week 08. By spectrophotometer
Change in concentration of antioxidants markers (micromol) 8 weeks Change in concentration of antioxidants markers from baseline to week 08. By spectrophotometer
Trial Locations
- Locations (1)
Yaounde Central Hospital, NAtional Obesity Center
🇨🇲Yaounde, Cameroon