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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Short Term Cardiovascular Effects of Zingiber Officinale as add-on Therapy in a Population of Type 2 Diabetes Individuals

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

Intervention / Treatment
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* Dietary Supplement: GINOFF1


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Non-randomized single-arm of GINOFF1<br>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 Zingiber officinale Roscoe extracts, at a daily dose of 2g/day (equivalent overall daily dose of extract in simple powdered form) for a period of 6weeks. The extracts were given as capsules, either one capsule three times per day (1 capsule x 3 / day) and after meals. Each capsule contains 399mg of pure Zingiber officinale Roscoe extracts. | Dietary Supplement: GINOFF1<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Variation of mitral E' velocity | The mitral E' velocity is one of the methods for evaluating diastolic function. | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Variation of transmitral flow parameters such as E velocity | E (early diastolic filling velocity) | 6 weeks | 
| Variation of blood pressure. | Change in systolic and diastolic blood pressure by using ABPM (mmHg) | 6 weeks | 
| Variation of weight loss | Change in weight (Kgs) | 6 weeks | 
| Variation of HbA1c | Change in HbA1c (%) | 6 weeks | 
| Variation of lipid profile. | Change of triglycerides, LDL cholesterol, HDL cholesterol | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes mellitus, Diastolic function, Blood pressure, Zingiber officinale