CompletedNot Applicable

Effect of Moringa Oleifera on Metformin Plasma Level in Type 2 Diabetes Mellitus Patients

25 participantsStarted 2016-03-01

Plain-language 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. 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.

Who can participate

Age range

49 Years – 77 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Fasting Blood Glucose

Timeframe: Change from Baseline Fasting Blood Glucose at 1 week

Change in Two-hour Post Prandial Blood Glucose

Timeframe: Change from Baseline Two-hour Post Prandial Blood Glucose at 1 week

Change in metformin trough plasma concentration

Timeframe: Change in metformin trough concentration at 1 week

Change in metformin peak plasma concentration

Timeframe: Change in metformin peak concentration at 1 week

Change in estimated glomerular filtration rate

Timeframe: Change in estimated glomerular filtration rate at 1 week

Trial details

NCT IDNCT03189407

SponsorTitilayo O Fakeye

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2016-04-30

View on ClinicalTrials.gov More Type 2 Diabetes Mellitus trials