Type 2 Diabetes MellitusNCT03189407
Effect of Moringa Oleifera on Metformin Plasma Level in Type 2 Diabetes Mellitus Patients
A study testing Moringa oleifera tea in people with Type 2 Diabetes Mellitus, run by Titilayo O Fakeye.
Trial summary
Type 2 diabetes mellitus (T2DM) patients from our previous survey tend to co-administer various herbs with their oral hypoglycemic agents (OHA). Some of these herbs are known to possess antidiabetic activities. One of such is Moringa oleifera leaves. Read more about this study
- Who is it for?
- Ages 49 to 77 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Moringa oleifera tea
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2016to 30 Apr 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 49 to 77 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ambulatory type 2 diabetes mellitus patients from 40 years of age who had supplemented their oral hypoglycaemic drugs with Moringa oleifera in the past but had stopped for over one month were recruited into the study.
Who cannot join
- Patients with co-morbidities such as congestive heart failure, liver disease, and those who had undergone recent surgical procedure were excluded from the study. Other types of patient excluded from the study were: patients on insulin or whose oral hypoglycaemic drug therapy does not include metformin, patients who take alcohol, patients who were on cimetidine, furosemide, nifedipine, ciprofloxacin, rifampicin, anti-retroviral therapy or any other medication with known interactions with metformin. Patients who smoked were also excluded.
About this study
Official title: Evaluation of the Effect of Moringa Oleifera Tea on Metformin Steady State Plasma Level in Type 2 Diabetes Mellitus Patients - a Pre and Post Non-randomised Trial
Type 2 diabetes mellitus (T2DM) patients from our previous survey tend to co-administer various herbs with their oral hypoglycemic agents (OHA). Some of these herbs are known to possess antidiabetic activities. One of such is Moringa oleifera leaves.
The present study evaluated the effects of seven days, twice-daily administration of hot water infusion of dried Moringa oleifera leaves on the steady state plasma concentrations of Metformin, one of the most widely used OHAs using T2DM patients who have been on Metformin for a period of not less than three months. The included patients had also been on Moringa supplementation but had terminated the use of Moringa at least a month to the start of the study.
Read more
Patients who had other comorbidities such as heart diseases, renal or hepatic impairments were excluded from the study. The patients were recruited from Endocriniology clinic of the Obafemi Awolowo University Teaching Hospitals complex, a tertiary hospital from southwest Nigeria.
Each patient served as his/her control.
Read the detailed description
Background Plant parts of Moringa oleifera Lam. (Moringaceae) is known to lower blood glucose level and as a result, type 2 diabetes mellitus patients (T2DM) sometimes use it as herbal supplements. This study therefore sought to evaluate the effects of coadministration of Moringa oleifera tea on steady state concentration of metformin in ambulatory T2DM patients attending a tertiary health facility in Nigeria.
Method This study used a non-randomized pre-test and post-test design to evaluate the effects of coadministration of Moringa tea and metformin on selected parameters in T2DM patients. Consented patients, aged 49 -77 years were stabilised on the same brand of metformin for seven days. On day 8 after an overnight fast, baseline fasting blood sugar (FBG) and 2-hour post prandial blood sugar (2-hPPBG) were determined using a glucometer. Blood samples were also collected at the appropriate times for evaluation of serum creatinine, trough and peak metformin plasma concentrations.
Thereafter, patients were given fourteen sachets of pre-packed 400 g dried Moringa oleifera leaves for preparation of Moringa tea for seven days (twice daily) while on their normal doses of metformin. On day 15 after an overnight fast, a repeat of FBG and 2-hPPBG was done using a glucometer. At the appropriate times, blood samples were also collected for determination of serum creatinine, trough and peak metformin plasma concentrations.
Serum was obtained from aliquots of the blood samples to determine serum creatinine for calculation of estimated glomerular filtration rate, eGFR. Plasma was obtained from the blood samples and were analysed using modified previously-validated HPLC method.
The values of FBG, 2-hPPBG, trough and peak metformin plasma concentrations obtained were compared with the baseline values using Paired sample t-test at P<0.05 considered significant in order to evaluate the effect of Moringa tea on the parameters.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Moringa oleifera tea
- Keywords
- Moringa Oleifera tea, Type 2 Diabetes Mellitus, Metformin Steady state concentrations, Herb-drug interaction
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moringa oleifera teaDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Moringa oleifera tea in T2DM patients | Other | The study was a pre/post design for type 2 diabetes mellitus patients on metformin in which each patient acted as his/her control. Intervention of twice daily pre-packed 400g dried Moringa oleifera leaves to be prepared as tea by the patients was done. Evaluation of the effect of the tea on metformin steady state concentrations and blood glucose measurements were done. Receives: Dietary Supplement: Moringa oleifera tea |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Fasting Blood Glucose
Blood glucose (mmol/L) after overnight fast after 7-day Moringa tea, with continuous use of metformin
Measured: Change from Baseline Fasting Blood Glucose at 1 week
Change in Two-hour Post Prandial Blood Glucose
Blood glucose (mmol/L) two hours after breakfast after 7-day Moringa tea, with continuous use of metformin
Measured: Change from Baseline Two-hour Post Prandial Blood Glucose at 1 week
Change in metformin trough plasma concentration
Plasma level of metformin (ug/mL) pre-dose in the morning after 7-day Moringa tea, with continuous use of metformin
Measured: Change in metformin trough concentration at 1 week
Change in metformin peak plasma concentration
Plasma level of metformin (ug/mL) two hours post dose after 7-day Moringa tea, with continuous use of metformin
Measured: Change in metformin peak concentration at 1 week
Change in estimated glomerular filtration rate
Calculation of glomerular filtration rate (mL/min) from serum creatinine level, pre and post 7-day Moringa tea supplementation and continuous use of metformin
Measured: Change in estimated glomerular filtration rate at 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2017
- Study start1 Mar 2016
- Primary completion30 Apr 2016
- Study completion30 Apr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Titilayo O Fakeye
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Titilayo O Fakeye, University of Ibadan
- Investigators
- Toyin Famurewa, B.Pharm;MSc, Principal investigator, Obafemi Awolowo University Hospitals Complex, Ile-Ife, Nigeria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03189407
- Sponsor's protocol ID
- DHI001
- Status last verified
- Jun 2017
- First submitted
- 5 Jun 2017
- Last updated
- 16 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data will only be made public as a publication in a peer-reviewed journal. Also, the Endocrinologist in the team is aware of the results obtained and the implications of using Moringa tea on therapy outcome for a patient on metformin
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Moringa Oleifera Tea on Metformin Steady State Plasma Level in Type 2 Diabetes Mellitus Patients - a Pre and Post Non-randomised Trial
- ClinicalTrials.gov ID
- NCT03189407
- Acronym / sponsor ID
- DHI001
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- Moringa Oleifera tea, Type 2 Diabetes Mellitus, Metformin Steady state concentrations, Herb-drug interaction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Titilayo O FakeyeUniversity, hospital or other
- Study start
- 1 Mar 2016 (actual)
- Primary completion
- 30 Apr 2016 (actual)
- Study completion
- 30 Apr 2016 (actual)
- First posted
- 16 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Type 2 diabetes mellitus (T2DM) patients from our previous survey tend to co-administer various herbs with their oral hypoglycemic agents (OHA). Some of these herbs are known to possess antidiabetic activities. One of such is Moringa oleifera leaves.
The present study evaluated the effects of seven days, twice-daily administration of hot water infusion of dried Moringa oleifera leaves on the steady state plasma concentrations of Metformin, one of the most widely used OHAs using T2DM patients who have been on Metformin for a period of not less than three months. The included patients had also been on Moringa supplementation but had terminated the use of Moringa at least a month to the start of the study.
Patients who had other comorbidities such as heart diseases, renal or hepatic impairments were excluded from the study. The patients were recruited from Endocriniology clinic of the Obafemi Awolowo University Teaching Hospitals complex, a tertiary hospital from southwest Nigeria.
Each patient served as his/her control.
Detailed description
Background Plant parts of Moringa oleifera Lam. (Moringaceae) is known to lower blood glucose level and as a result, type 2 diabetes mellitus patients (T2DM) sometimes use it as herbal supplements. This study therefore sought to evaluate the effects of coadministration of Moringa oleifera tea on steady state concentration of metformin in ambulatory T2DM patients attending a tertiary health facility in Nigeria.
Method This study used a non-randomized pre-test and post-test design to evaluate the effects of coadministration of Moringa tea and metformin on selected parameters in T2DM patients. Consented patients, aged 49 -77 years were stabilised on the same brand of metformin for seven days. On day 8 after an overnight fast, baseline fasting blood sugar (FBG) and 2-hour post prandial blood sugar (2-hPPBG) were determined using a glucometer. Blood samples were also collected at the appropriate times for evaluation of serum creatinine, trough and peak metformin plasma concentrations.
Thereafter, patients were given fourteen sachets of pre-packed 400 g dried Moringa oleifera leaves for preparation of Moringa tea for seven days (twice daily) while on their normal doses of metformin. On day 15 after an overnight fast, a repeat of FBG and 2-hPPBG was done using a glucometer. At the appropriate times, blood samples were also collected for determination of serum creatinine, trough and peak metformin plasma concentrations.
Serum was obtained from aliquots of the blood samples to determine serum creatinine for calculation of estimated glomerular filtration rate, eGFR. Plasma was obtained from the blood samples and were analysed using modified previously-validated HPLC method.
The values of FBG, 2-hPPBG, trough and peak metformin plasma concentrations obtained were compared with the baseline values using Paired sample t-test at P<0.05 considered significant in order to evaluate the effect of Moringa tea on the parameters.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Moringa oleifera tea in T2DM patients | Other | Dietary Supplement: Moringa oleifera teaThe study was a pre/post design for type 2 diabetes mellitus patients on metformin in which each patient acted as his/her control. Intervention of twice daily pre-packed 400g dried Moringa oleifera leaves to be prepared as tea by the patients was done. Evaluation of the effect of the tea on metformin steady state concentrations and blood glucose measurements were done. |
Who may qualify
- Ages
- 49 to 77 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Ambulatory type 2 diabetes mellitus patients from 40 years of age who had supplemented their oral hypoglycaemic drugs with Moringa oleifera in the past but had stopped for over one month were recruited into the study.
Key exclusion criteria (1 listed)
- Patients with co-morbidities such as congestive heart failure, liver disease, and those who had undergone recent surgical procedure were excluded from the study. Other types of patient excluded from the study were: patients on insulin or whose oral hypoglycaemic drug therapy does not include metformin, patients who take alcohol, patients who were on cimetidine, furosemide, nifedipine, ciprofloxacin, rifampicin, anti-retroviral therapy or any other medication with known interactions with metformin. Patients who smoked were also excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Moringa oleifera tea | Dietary supplement | Moringa oleifera tea in T2DM patients |
Primary outcome
Change in Fasting Blood Glucose
Time frame: Change from Baseline Fasting Blood Glucose at 1 week
Blood glucose (mmol/L) after overnight fast after 7-day Moringa tea, with continuous use of metformin
Change in Two-hour Post Prandial Blood Glucose
Time frame: Change from Baseline Two-hour Post Prandial Blood Glucose at 1 week
Blood glucose (mmol/L) two hours after breakfast after 7-day Moringa tea, with continuous use of metformin
Change in metformin trough plasma concentration
Time frame: Change in metformin trough concentration at 1 week
Plasma level of metformin (ug/mL) pre-dose in the morning after 7-day Moringa tea, with continuous use of metformin
Change in metformin peak plasma concentration
Time frame: Change in metformin peak concentration at 1 week
Plasma level of metformin (ug/mL) two hours post dose after 7-day Moringa tea, with continuous use of metformin
Change in estimated glomerular filtration rate
Time frame: Change in estimated glomerular filtration rate at 1 week
Calculation of glomerular filtration rate (mL/min) from serum creatinine level, pre and post 7-day Moringa tea supplementation and continuous use of metformin
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2017.
- Individual participant dataSharing planned: No. The data will only be made public as a publication in a peer-reviewed journal. Also, the Endocrinologist in the team is aware of the results obtained and the implications of using Moringa tea on therapy outcome for a patient on metformin
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Toyin Famurewa, B.Pharm;MSc principal investigator
Obafemi Awolowo University Hospitals Complex, Ile-Ife, Nigeria
Questions about this trial
What is this clinical trial studying?
A study testing Moringa oleifera tea in people with Type 2 Diabetes Mellitus, run by Titilayo O Fakeye.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Fasting Blood Glucose (time frame: Change from Baseline Fasting Blood Glucose at 1 week). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2017.