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NCT Number: NCT04222686

Evaluation of Losartan and Perindopril in Blacks Type 2 Diabetics Patients

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.

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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

21 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Yaounde Central Hospital, NAtional Obesity Center

Yaoundé, Cameroon

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Perindopril Arginine

Drug

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

Other names: Perindopril

Losartan Potassium

Drug

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

Other names: Losartan

Primary outcomes

  1. 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

  1. Change in rest urinary albumin excretion

    Time frame: 8 weeks

    Change in rest urinary albumin excretion (mg/l) from baseline to week 08. By nephelometry method.

  2. Change in mitral E/Ea ratio

    Time frame: 8 weeks

    Change in mitral E/Ea ratio from baseline to week 08. By tissue doppler on echocardiography.

  3. Change in nycthemeral blood pressure profile (mmHg)

    Time frame: 8 weeks

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

  4. Change in concentration of antioxidants markers (micromol)

    Time frame: 8 weeks

    Change in concentration of antioxidants markers from baseline to week 08. By spectrophotometer

  5. Change in lipid profile (triglycerides, Total cholesterol, HDL-cholesterol, LDL-cholesterol) on g/l

    Time frame: 8 weeks

    Change in lipid profile from baseline to week 08. By spectrophotometer

  6. Change in uricemia concentration

    Time frame: 8 weeks

    Change in uricemia concentration (mg/l) from baseline to week 08. By spectrophotometer

Sponsors and collaborators

Lead sponsor

Yaounde Central Hospital

Other Gov

Registry information

Official study 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

Acronym: CARE-PLP

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jan 10, 2020
Registry last updated
Jan 10, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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