The Cardiovascular and Renal Effects of Moringa Oleifera Extracts and Stevia Rebaudiana Bertoni in Patients With Type II Diabetes Mellitus
NCT ID: NCT04254029
Last Updated: 2020-02-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
19 participants
INTERVENTIONAL
2016-11-01
2017-05-01
Brief Summary
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Detailed Description
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Intervention consisted of the administration of a daily consummation of 425 ml of drink containing the extracts of 1,38mg of leaves extracts of moringa oleifera and 23,46 mg of stevia rebaudiana Bertoni leaves extracts lasting 45 days. 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, urinary excretion of albumin 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, blood pressure controls and urinary excretion albumin tests were done for safety purposes.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Non-randomized single-arm of MOROLSTEVER1
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 of a daily consummation of 425 ml of drink containing the extracts of 1,38mg of leaves extracts of moringa oleifera and 23,46 mg of stevia rebaudiana Bertoni leaves extracts lasting 45 days.
MOROLSTEVER1
The intervention consisted of a daily consummation of 425 ml of drink containing the extracts of 1,38mg of leaves extracts of moringa oleifera and 23,46 mg of stevia rebaudiana Bertoni leaves extracts lasting 45 days.
Interventions
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MOROLSTEVER1
The intervention consisted of a daily consummation of 425 ml of drink containing the extracts of 1,38mg of leaves extracts of moringa oleifera and 23,46 mg of stevia rebaudiana Bertoni leaves extracts lasting 45 days.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* Cardiac, renal disease and liver pathologies Sensitivity, intolerance or allergy to moringa or stevia Discontinued intervention
* Withdrawal of consent
21 Years
75 Years
ALL
No
Sponsors
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Yaounde Central Hospital
OTHER_GOV
Responsible Party
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CN NGANOU-GNINDJIO, MD, MSc
Dr, Principal investigator
Locations
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Yaounde Central Hospital, NAtional Obesity Center
Yaoundé, , Cameroon
Countries
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Other Identifiers
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MOROLSTEVER1
Identifier Type: -
Identifier Source: org_study_id
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