Clinical trial NCT04222686: Evaluation of Losartan and Perindopril in Blacks Type 2 Diabetics Patients
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Type 2 Diabetes Mellitus
Keywords: Angiotensin Converting Enzymes Inhibitor
Angiotensin II Receptor Blockers
Type 2 Diabetes
Exercise induced urinary albumin excretion
Blood pressure
Lead sponsor: Yaounde Central Hospital
Sponsor class: OTHER_GOV
First posted: 2020-01-10
Enrollment: 23
Sex: ALL
Minimum age (years): 21
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: CARE-PLP trial is a double blind, randomized, controlled parallel clinical trial conducted in the National Obesity Center, Yaounde, Cameroon
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Variation of exercise-induced urinary albumin excretion
timeFrame: 8 weeks
Secondary outcomes:
measure: Change in rest urinary albumin excretion
timeFrame: 8 weeks
measure: Change in mitral E/Ea ratio
timeFrame: 8 weeks
measure: Change in nycthemeral blood pressure profile (mmHg)
timeFrame: 8 weeks
measure: Change in concentration of antioxidants markers (micromol)
timeFrame: 8 weeks
measure: Change in lipid profile (triglycerides, Total cholesterol, HDL-cholesterol, LDL-cholesterol) on g/l
timeFrame: 8 weeks
measure: Change in uricemia concentration
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Yaounde
country: Cameroon
facility: Yaounde Central Hospital, NAtional Obesity Center
Study officials:
affiliation: Yaounde Central Hospital
name: Chris Nadege NGANOU-GNINDJIO, MD, MAS
role: PRINCIPAL_INVESTIGATOR
References: