Evaluation of Losartan and Perindopril in Blacks Type 2 Diabetics Patients

NCT ID: NCT04222686

Last Updated: 2020-01-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-12-20
• Study Completion Date: 2018-04-30

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.

Conditions

Type 2 Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Perindopril Arginine

Intervention Type: DRUG

10 mg Perindopril tablet / day will be added to the usual treatment for each patient for a period of 8 weeks.

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.

Group Type: ACTIVE_COMPARATOR

Losartan Potassium

Intervention Type: DRUG

100 mg Losartan tablet will be added to the usual treatment for each patient for a period of 08 weeks.

Interventions

Perindopril Arginine

10 mg Perindopril tablet / day will be added to the usual treatment for each patient for a period of 8 weeks.

Intervention Type: DRUG

Losartan Potassium

100 mg Losartan tablet will be added to the usual treatment for each patient for a period of 08 weeks.

Intervention Type: DRUG

Other Intervention Names

Perindopril; Losartan

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yaounde Central Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

CN NGANOU-GNINDJIO, MD, MSc

Dr, Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Chris Nadege NGANOU-GNINDJIO, MD, MAS

Role: PRINCIPAL_INVESTIGATOR

Yaounde Central Hospital

Locations

Yaounde Central Hospital, NAtional Obesity Center

Yaoundé, , Cameroon

Countries

Cameroon

Other Identifiers

CARE-PLP

Identifier Type: -

Identifier Source: org_study_id