The Cardiovascular and Renal Effects of Moringa Oleifera Extracts and Stevia Rebaudiana Bertoni in Patients With Type II Diabetes Mellitus

Yaounde Central Hospital19 enrolled

Overview

The aim of the study was the evaluation of cardiovascular and renal benefits of moringa oleifera and stevia rebaudiana Bertoni in patients with type 2 diabetes mellitus before and after 8 weeks of add-on therapy.

The investigators performed a non-randomized single-arm clinical trial with a before and after design, carried out from November 2016 and May 2017. Intervention consisted of the administration of a daily consummation of 425 ml of drink containing the extracts of 1,38mg of leaves extracts of moringa oleifera and 23,46 mg of stevia rebaudiana Bertoni leaves extracts lasting 45 days. Before and after intervention, the following were done by the participants: bioelectrical impedance analysis (BIA), blood pressure measurements, fasting blood sugar, HbA1c, lipid profiles, liver function tests, kidney function tests, urinary excretion of albumin tests and full blood counts. These were followed by morphological workup including Electrocardiograms (ECGs), transthoracic heart ultrasounds and Ambulatory Blood Pressure Measurements (ABPM), also done before and after intervention. Clinical evaluation with fasting blood sugar control, blood pressure controls and urinary excretion albumin tests were done for safety purposes.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Benefits of a Capsules of Moringa Oleifera and Stevia Rebaudiana Bertoni in Patients With Type 2 Diabetes Mellitus Before and After 45 Days of add-on Therapy

Interventions

MOROLSTEVER1DIETARY_SUPPLEMENT

The intervention consisted of a daily consummation of 425 ml of drink containing the extracts of 1,38mg of leaves extracts of moringa oleifera and 23,46 mg of stevia rebaudiana Bertoni leaves extracts lasting 45 days.

Eligibility

Sex: ALLMin age: 21 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Known T2DM patients aged above 21years * No change in anti-diabetic medication during the last three months HbA1c between 42 to 64mmol/mol (6-8%) * Clearance of creatinine calculated according to the Modification of Diet in Renal Disease equation\> 60ml/min/1.73 m2 Exclusion Criteria: * Patient already on moringa or stevia supplementation or other herbal medication drugs that could interact with moringa or whose effects may be amplified, as far back as 1 month before study. * Cardiac, renal disease and liver pathologies Sensitivity, intolerance or allergy to moringa or stevia Discontinued intervention * Withdrawal of consent

Locations (1)

Yaounde Central Hospital, NAtional Obesity Center

Yaoundé, Cameroon

Outcomes

Primary Outcomes

Variation of mitral E' velocity

The mitral E' velocity is one of the methods for evaluating diastolic function.

Time frame: 45 days

Secondary Outcomes

Variation of transmitral flow parameters such as E velocity

E (early diastolic filling velocity)

Time frame: 45 days

Urinary excretion of albumin

Urinary excretion of albumin level

Time frame: 45 days

Variation of blood pressure.

Change in systolic and diastolic blood pressure by using ABPM (mmHg)

Time frame: 45 days

Data from ClinicalTrials.gov

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