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
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 23
- Locations
- 1
- Primary Endpoint
- Variation of exercise-induced urinary albumin excretion
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- 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.
Eligibility Criteria
- Ages
- 21 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.
Intervention: Perindopril Arginine (Drug)
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.
Intervention: Losartan Potassium (Drug)
Outcomes
Primary Outcomes
Variation of exercise-induced urinary albumin excretion
Time Frame: 8 weeks
Variation of exercise-induced urinary albumin excretion (mg/j) between week 0 and week 8. By nephelometry method.
Secondary Outcomes
- Change in mitral E/Ea ratio(8 weeks)
- Change in lipid profile (triglycerides, Total cholesterol, HDL-cholesterol, LDL-cholesterol) on g/l(8 weeks)
- Change in rest urinary albumin excretion(8 weeks)
- Change in nycthemeral blood pressure profile (mmHg)(8 weeks)
- Change in uricemia concentration(8 weeks)
- Change in concentration of antioxidants markers (micromol)(8 weeks)
Investigators
CN NGANOU-GNINDJIO, MD, MSc
Dr, Principal investigator
Yaounde Central Hospital