Evaluation of Losartan and Perindopril in Blacks Type 2 Diabetics Patients

Type 2 Diabetes Mellitus Clinical Trial

— CARE-PLP  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04222686
• Other study ID #: CARE-PLP
• Status: Completed
• Phase: Phase 4
• Start date: December 20, 2017
• Est. completion date: April 30, 2018

Study information

• Verified date: January 2020
• Source: Yaounde Central Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: April 30, 2018
• Est. primary completion date: February 15, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• Perindopril Arginine
10 mg Perindopril tablet / day will be added to the usual treatment for each patient for a period of 8 weeks.
• Losartan Potassium
100 mg Losartan tablet will be added to the usual treatment for each patient for a period of 08 weeks.

Locations

Country	Name	City	State
Cameroon	Yaounde Central Hospital, NAtional Obesity Center	Yaounde

Sponsors (1)

Lead Sponsor	Collaborator
Yaounde Central Hospital

Country where clinical trial is conducted

Cameroon, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Variation of exercise-induced urinary albumin excretion	Variation of exercise-induced urinary albumin excretion (mg/j) between week 0 and week 8. By nephelometry method.	8 weeks
Secondary	Change in rest urinary albumin excretion	Change in rest urinary albumin excretion (mg/l) from baseline to week 08. By nephelometry method.	8 weeks
Secondary	Change in mitral E/Ea ratio	Change in mitral E/Ea ratio from baseline to week 08. By tissue doppler on echocardiography.	8 weeks
Secondary	Change in nycthemeral blood pressure profile (mmHg)	Change in nycthemeral blood pressure profile from baseline to week 08. By using Arterial Blood Pressure Monitoring.	8 weeks
Secondary	Change in concentration of antioxidants markers (micromol)	Change in concentration of antioxidants markers from baseline to week 08. By spectrophotometer	8 weeks
Secondary	Change in lipid profile (triglycerides, Total cholesterol, HDL-cholesterol, LDL-cholesterol) on g/l	Change in lipid profile from baseline to week 08. By spectrophotometer	8 weeks
Secondary	Change in uricemia concentration	Change in uricemia concentration (mg/l) from baseline to week 08. By spectrophotometer	8 weeks