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

NCT04254016 | Completed Phase 4 DMC

• 1 other identifier: HIBISTEVER
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Variation of mitral E' velocity

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

  8 weeks

Secondary Outcomes (4)

• Urinary excretion of albumin

  8 weeks

• Variation of transmitral flow parameters such as E velocity

  8 weeks

• Variation of blood pressure.

  8 weeks

• Variation of lipid profile.

  8 weeks

Study Arms (1)

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.

Dietary Supplement: HIBISTEVER1

Interventions

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.

Non-randomized single-arm of HIBISTEVER1

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yaounde Central Hospital: lead

Study Sites (1)

Yaounde Central Hospital, NAtional Obesity Center

Yaoundé, Cameroon

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr, Principal investigator

Study Record Dates

• First Submitted: January 31, 2020
• First Posted: February 5, 2020
• Study Start: November 1, 2016
• Primary Completion: May 1, 2017
• Study Completion: May 1, 2017
• Last Updated: February 5, 2020

Record last verified: 2020-01

Locations

CA (1)