Clinical trial NCT04254029: The Cardiovascular and Renal Effects of Moringa Oleifera Extracts and Stevia Rebaudiana Bertoni in Patients With Type II Diabetes Mellitus
Official title: Short Term Cardiovascular and Renal Effects of Moringa Oleifera Extracts and Stevia Rebaudiana Bertoni as add-on Therapy in a Population of Type II Diabetes Individuals
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
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
Keywords: Diastolic function
Blood pressure profile
moringa oleifera
Stevia rebaudiana bertoni
Diabetes mellitus
Lead sponsor: Yaounde Central Hospital
Sponsor class: OTHER_GOV
First posted: 2020-02-05
Enrollment: 19
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Variation of mitral E' velocity
timeFrame: 45 days
Secondary outcomes:
measure: Variation of transmitral flow parameters such as E velocity
timeFrame: 45 days
measure: Urinary excretion of albumin
timeFrame: 45 days
measure: Variation of blood pressure.
timeFrame: 45 days
Other outcomes:
Locations:
city: Yaounde
country: Cameroon
facility: Yaounde Central Hospital, NAtional Obesity Center
Study officials:
References: