Short Term Effects of a Hibiscus Sabdariffa and Stevia Rebaudiana Drink on Cardiac Relaxation and Urinary Albumin Excretion in a Group of Diabetic Type 2 Subjects

Yaounde Central Hospital22 enrolled

Overview

The aim of this study is to evaluate the effects of a Hibiscus Sabdariffa and Stevia Rebaudiana drink on cardiac relaxation and urinary albumin excretion in a group of diabetic type II patients.

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 Hibiscus-Stevia drink at a dose of 4 mg / kg / day for Stevia and 4 g / day for Hibiscus for a period of 8 weeks. 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 at the 30th and 60th days for safety purposes.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Benefits of a Hibiscus Sabdariffa and Stevia Rebaudiana Drink in Patients With Type 2 Diabetes Mellitus Before and After 8 Weeks of add-on Therapy

Interventions

HIBISTEVER1DIETARY_SUPPLEMENT

During 8 weeks, administration of a Hibiscus-Stevia drink for 8 weeks at a dose of 4 mg / kg / day for Stevia and 4 g / day for Hibiscus. Evaluation will take place the 30th and 60th 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 Hibiscus or stevia supplementation or other herbal medication Drugs that could interact with hibiscus 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 hibiscus 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: 8 weeks

Secondary Outcomes

Urinary excretion of albumin

Urinary excretion of albumin level

Time frame: 8 weeks

Variation of transmitral flow parameters such as E velocity

E (early diastolic filling velocity)

Time frame: 8 weeks

Variation of blood pressure.

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

Time frame: 8 weeks

Variation of lipid profile.

Change of triglycerides, LDL cholesterol, HDL cholesterol

Time frame: 8 weeks

Data from ClinicalTrials.gov

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