Cardiovascular Benefits of Zingiber Officinale Roscoe in Patients With Type 2 Diabetes Mellitus Before and After 6 Weeks of add-on Therapy
Conditions
Keywords
Diabetes mellitus, Diastolic function, Blood pressure, Zingiber officinale
Brief summary
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.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTGINOFF1
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.
Sponsors
NGATI Denetria NYONGA, Dr
SOBNGWI Eugène, Pr
MBANYA Jean Claude, Pr
Yaounde Central Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Variation of mitral E' velocity | 6 weeks | The mitral E' velocity is one of the methods for evaluating diastolic function. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Variation of transmitral flow parameters such as E velocity | 6 weeks | E (early diastolic filling velocity) |
| Variation of blood pressure. | 6 weeks | Change in systolic and diastolic blood pressure by using ABPM (mmHg) |
| Variation of weight loss | 6 weeks | Change in weight (Kgs) |
| Variation of HbA1c | 6 weeks | Change in HbA1c (%) |
| Variation of lipid profile. | 6 weeks | Change of triglycerides, LDL cholesterol, HDL cholesterol |
Countries
Cameroon
Outcome results
None listed