The Cardiovascular Effects of Ginger (Zingiber Officinale) in Patients With Type II Diabetes Mellitus

Yaounde Central Hospital21 enrolled

Overview

The aim of the study was the evaluation of cardiovascular benefits of Zingiber officinale Roscoe in patients with type 2 diabetes mellitus before and after 6 weeks of add-on therapy.

the investigators performed a non-randomized single-arm clinical trial with a before and after design, carried out from December 2016 and May 2017. Intervention consisted of the administration of powdered ginger extracts in the form of capsules at a dose of 2g/day, for a period of 6 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 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 and blood pressure controls were done at day 21 for safety purposes.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Cardiovascular Benefits of Zingiber Officinale Roscoe in Patients With Type 2 Diabetes Mellitus Before and After 6 Weeks of add-on Therapy

Interventions

GINOFF1DIETARY_SUPPLEMENT

The intervention lasted for six weeks and consisted of the administration of powdered ginger extracts in the form of capsules at a dose of 2g/day.

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%). Exclusion Criteria: * Patient already on ginger supplementation or other herbal medication * Drugs that could interact with ginger or whose effects may be amplified such as NSAIDS, corticosteroids and anticoagulants like heparin or warfarin, as far back as 1 month before study. * Cardiac, renal disease and liver pathologies * Heartburn or peptic ulcer disease * Sensitivity, intolerance or allergy to ginger * 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: 6 weeks

Secondary Outcomes

Variation of transmitral flow parameters such as E velocity

E (early diastolic filling velocity)

Time frame: 6 weeks

Variation of blood pressure.

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

Time frame: 6 weeks

Variation of weight loss

Change in weight (Kgs)

Time frame: 6 weeks

Variation of HbA1c

Change in HbA1c (%)

Time frame: 6 weeks

Variation of lipid profile.

Change of triglycerides, LDL cholesterol, HDL cholesterol

Time frame: 6 weeks

Data from ClinicalTrials.gov

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