Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Perindopril Arm | Active Comparator | 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. |
|
| Losartan Arm | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Perindopril Arginine | Drug | 10 mg Perindopril tablet / day will be added to the usual treatment for each patient for a period of 8 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in rest urinary albumin excretion | Change in rest urinary albumin excretion (mg/l) from baseline to week 08. By nephelometry method. | 8 weeks |
| Change in mitral E/Ea ratio | Change in mitral E/Ea ratio from baseline to week 08. By tissue doppler on echocardiography. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Chris Nadege NGANOU-GNINDJIO, MD, MAS | Yaounde Central Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yaounde Central Hospital, NAtional Obesity Center | Yaoundé | Cameroon |
Not provided
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000608172 | Viacoram |
| D020913 | Perindopril |
| D019808 | Losartan |
| ID | Term |
|---|---|
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
CARE-PLP trial is a double blind, randomized, controlled parallel clinical trial conducted in the National Obesity Center, Yaounde, Cameroon
Not provided
Not provided
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.
| Losartan Potassium | Drug | 100 mg Losartan tablet will be added to the usual treatment for each patient for a period of 08 weeks. |
|
|
| 8 weeks |
| 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 |
| Change in concentration of antioxidants markers (micromol) | Change in concentration of antioxidants markers from baseline to week 08. By spectrophotometer | 8 weeks |
| 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 |
| Change in uricemia concentration | Change in uricemia concentration (mg/l) from baseline to week 08. By spectrophotometer | 8 weeks |
| D004700 | Endocrine System Diseases |
| D001713 | Biphenyl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D013777 | Tetrazoles |