Evaluation of Losartan and Perindopril in Blacks Type 2 Diabetics Patients

NCT04222686 | Completed Phase 4 DMC

• 1 other identifier: CARE-PLP
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes Mellitus

Keywords

Angiotensin Converting Enzymes Inhibitor; Angiotensin II Receptor Blockers; Type 2 Diabetes; Exercise induced urinary albumin excretion; Blood pressure

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Change in rest urinary albumin excretion

  8 weeks

• Change in mitral E/Ea ratio

  8 weeks

• Change in nycthemeral blood pressure profile (mmHg)

  8 weeks

• Change in concentration of antioxidants markers (micromol)

  8 weeks

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

  8 weeks

Study Arms (2)

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.

Drug: Perindopril Arginine

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.

Drug: Losartan Potassium

Interventions

Perindopril Arginine DRUG

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

Also known as: Perindopril

Perindopril Arm

Losartan Potassium DRUG

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

Also known as: Losartan

Losartan Arm

Eligibility Criteria

• Age: 21 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Side effects affecting life quality of patients (determined by the Data Safety Monitoring Board).
• Signs of exercise intolerance
• Out of sight.
• Withdrawal of consent

Sponsors & Collaborators

• Yaounde Central Hospital: lead

Study Sites (1)

Yaounde Central Hospital, NAtional Obesity Center

Yaoundé, Cameroon

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Viacoram; Perindopril; Losartan

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Tetrazoles

Study Officials

• Chris Nadege NGANOU-GNINDJIO, MD, MAS

  Yaounde Central Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr, Principal investigator

Model Details: CARE-PLP trial is a double blind, randomized, controlled parallel clinical trial conducted in the National Obesity Center, Yaounde, Cameroon

Study Record Dates

• First Submitted: April 8, 2019
• First Posted: January 10, 2020
• Study Start: December 20, 2017
• Primary Completion: February 15, 2018
• Study Completion: April 30, 2018
• Last Updated: January 10, 2020

Record last verified: 2020-01

Locations

CA (1)