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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non-randomized single-arm of HIBISTEVER1 | Experimental | Non-randomized single-arm clinical trial with a before and after design. The study population consisted on all type 2 diabetes mellitus (T2DM) patients with a target population of T2DM patients with HbA1c between 42 to 64mmol/mol (6-8%) with no change in anti-diabetic treatment during the last three months, previous the study. The intervention consisted on the administration of 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 and after meals. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HIBISTEVER1 | Dietary 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Variation of mitral E' velocity | The mitral E' velocity is one of the methods for evaluating diastolic function. | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Urinary excretion of albumin | Urinary excretion of albumin level | 8 weeks |
| Variation of transmitral flow parameters such as E velocity | E (early diastolic filling velocity) |
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Inclusion Criteria:
Exclusion Criteria:
Cardiac, renal disease and liver pathologies Sensitivity, intolerance or allergy to hibiscus or stevia Discontinued intervention Withdrawal of consent
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yaounde Central Hospital, NAtional Obesity Center | Yaoundé | Cameroon |
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| 8 weeks |
| Variation of blood pressure. | Change in systolic and diastolic blood pressure by using ABPM (mmHg) | 8 weeks |
| Variation of lipid profile. | Change of triglycerides, LDL cholesterol, HDL cholesterol | 8 weeks |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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