Clinical trial NCT04254016: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
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
Keywords: Diastolic function
Blood pressure
Diabetes mellitus
Hibiscus Sabdariffa
Stevia Rebaudiana
Lead sponsor: Yaounde Central Hospital
Sponsor class: OTHER_GOV
First posted: 2020-02-05
Enrollment: 22
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 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.

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 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.

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 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

Primary outcomes:
measure: Variation of mitral E' velocity
timeFrame: 8 weeks
Secondary outcomes:
measure: Urinary excretion of albumin
timeFrame: 8 weeks
measure: Variation of transmitral flow parameters such as E velocity
timeFrame: 8 weeks
measure: Variation of blood pressure.
timeFrame: 8 weeks
measure: Variation of lipid profile.
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Yaounde
country: Cameroon
facility: Yaounde Central Hospital, NAtional Obesity Center
Study officials:
References: