Type 2 Diabetes Mellitus
Conditions
Keywords
Angiotensin Converting Enzymes Inhibitor, Angiotensin II Receptor Blockers, Type 2 Diabetes, Exercise induced urinary albumin excretion, Blood pressure
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.
Interventions
10 mg Perindopril tablet / day will be added to the usual treatment for each patient for a period of 8 weeks.
DRUGLosartan Potassium
100 mg Losartan tablet will be added to the usual treatment for each patient for a period of 08 weeks.
Sponsors
Yaounde Central Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
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.
Intervention model description
CARE-PLP trial is a double blind, randomized, controlled parallel clinical trial conducted in the National Obesity Center, Yaounde, Cameroon
Eligibility
Sex/Gender
ALL
Age
21 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Variation of exercise-induced urinary albumin excretion | 8 weeks | Variation of exercise-induced urinary albumin excretion (mg/j) between week 0 and week 8. By nephelometry method. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in mitral E/Ea ratio | 8 weeks | Change in mitral E/Ea ratio from baseline to week 08. By tissue doppler on echocardiography. |
| Change in nycthemeral blood pressure profile (mmHg) | 8 weeks | Change in nycthemeral blood pressure profile from baseline to week 08. By using Arterial Blood Pressure Monitoring. |
| Change in rest urinary albumin excretion | 8 weeks | Change in rest urinary albumin excretion (mg/l) from baseline to week 08. By nephelometry method. |
| Change in lipid profile (triglycerides, Total cholesterol, HDL-cholesterol, LDL-cholesterol) on g/l | 8 weeks | Change in lipid profile from baseline to week 08. By spectrophotometer |
| Change in uricemia concentration | 8 weeks | Change in uricemia concentration (mg/l) from baseline to week 08. By spectrophotometer |
| Change in concentration of antioxidants markers (micromol) | 8 weeks | Change in concentration of antioxidants markers from baseline to week 08. By spectrophotometer |
Countries
Cameroon
Outcome results
None listed