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

NCT03189407 | Completed

• 1 other identifier: DHI001
• Study Type: interventional
• Target: 25
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Type 2 Diabetes Mellitus

Keywords

Moringa Oleifera tea; Type 2 Diabetes Mellitus; Metformin Steady state concentrations; Herb-drug interaction

Outcome Measures

Primary Outcomes (5)

• Change in Fasting Blood Glucose

  Blood glucose (mmol/L) after overnight fast after 7-day Moringa tea, with continuous use of metformin

  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

  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

  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

  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

  Change in estimated glomerular filtration rate at 1 week

Study Arms (1)

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.

Dietary Supplement: Moringa oleifera tea

Interventions

Moringa oleifera tea DIETARY_SUPPLEMENT

Moringa oleifera tea in T2DM patients

Eligibility Criteria

• Age: 49 Years - 77 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Titilayo O Fakeye: lead

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Toyin Famurewa, B.Pharm;MSc

  Obafemi Awolowo University Hospitals Complex, Ile-Ife, Nigeria

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 5, 2017
• First Posted: June 16, 2017
• Study Start: March 1, 2016
• Primary Completion: April 30, 2016
• Study Completion: April 30, 2016
• Last Updated: June 16, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share