Clinical trial NCT04222738: The Cardiovascular Effects of Ginger (Zingiber Officinale) in Patients With Type II Diabetes Mellitus
Official title: Short Term Cardiovascular Effects of Zingiber Officinale as add-on Therapy in a Population of Type 2 Diabetes Individuals
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cardiovascular Benefits of Zingiber Officinale Roscoe in Patients With Type 2 Diabetes Mellitus Before and After 6 Weeks of add-on Therapy
Keywords: Diabetes mellitus
Diastolic function
Blood pressure
Zingiber officinale
Lead sponsor: Yaounde Central Hospital
Sponsor class: OTHER_GOV
Collaborators: name: NGATI Denetria NYONGA, Dr
name: SOBNGWI Eugène, Pr
name: MBANYA Jean Claude, Pr
First posted: 2020-01-10
Enrollment: 21
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Variation of mitral E' velocity
timeFrame: 6 weeks
Secondary outcomes:
measure: Variation of transmitral flow parameters such as E velocity
timeFrame: 6 weeks
measure: Variation of blood pressure.
timeFrame: 6 weeks
measure: Variation of weight loss
timeFrame: 6 weeks
measure: Variation of HbA1c
timeFrame: 6 weeks
measure: Variation of lipid profile.
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Yaounde
country: Cameroon
facility: Yaounde Central Hospital, NAtional Obesity Center
Study officials:
affiliation: Yaounde Central Hospital
name: Chris Nadege NGANOU-GNINDJIO, MD, MAS
role: PRINCIPAL_INVESTIGATOR
affiliation: Yaounde Central Hospital
name: Eugene SOBNGWI, Professor
role: STUDY_DIRECTOR
affiliation: Yaounde Central Hospital
name: Jean Claude MBANYA, Professor
role: STUDY_CHAIR
References:
citation: Nganou-Gnindjio CN, Ngati Nyonga D, Wafeu GS, Nga EN, Sobngwi E. Cardiometabolic effects of ZingiberOfficinale Roscoe extracts in Type 2 diabetic Cameroonians patients after six weeks of add-on Therapy : A single clinical-arm trial. Ann Cardiol Angeiol (Paris). 2022 Jun;71(3):160-165. doi: 10.1016/j.ancard.2021.09.010. Epub 2022 Jan 14. French.