Metformin Usage Index and Vitamin B12 Status in Egyptian Type 2 Diabetic Patients

March 22, 2022 updated by: Mona Youssry Helmy, Cairo University

Metformin Usage Index and Vitamin B12 Status in Egyptian Type 2 Diabetic Patients : A Case Control Study .

Current data estimated that 451 million people, (age 18-99 years) suffered from diabetes world wide in 2017, and are expected to rise to 693 million by 2045. Among them, type 2 diabetes mellitus (T2DM) accounts for around 90% of all cases with diabetes.

T2DM is associated with several deterimental microvascular and macrovascular complications (Annani-Akollor ME et al ., 2019) . As such, effective management of the disease is crucial.

The American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD) recommend metformin as the first therapeutic choice for T2DM management with concurrent lifestyle modifications. Reports indicated that metformin improves peripheral insulin sensitivity and reduces the risk of cardiovascular mortality in T2DM in addition to its beneficial effects on weight loss and vascular protection.

Nonetheless, as with most medications, metformin has some side effects. Though most of these side effects are mild, reports indicated that metformin use is associated with diminution of vitamin B12 level . Also, advanced age of patients with T2DM, nutritional deficiency, and malabsorption are other contributing factors for its deficiency .

The proposed mechanisms for deficiency include, impairment of calcium dependent absorption from the gut, alteration in small bowel motility resulting in bacterial overgrowth, and a reduction in intrinsic factor levels .

Metformin-induced vitamin B12 deficiency has also been associated with neuropathy. The neuropathy associated with vitamin B12 deficiency ranges from paresthesia and attenuated peripheral sensation in response to changes in mental status and proprioception which overlap with diabetic neuropathy.

The progression of vitamin B12 deficiency-induced neurologic damage can, however, be abated through early detection and vitamin B12 therapy. Nonetheless, if peripheral neuropathy due to deficiency of vitamin B12 is misconstrued as diabetic peripheral neuropathy , permanent neurological damage may occur.

Several studies have investigated the individual effects of the dose and duration of metformin therapy on vitamin B12 levels .The reported results are inconsistent, with some studies reporting an association with the dose but not the duration and other studies reporting an association only for the duration. however, A few studies did not find an association with either the dose or the duration..

This could be attributed to the fact that, in any given patient with T2DM, vitamin B12 levels could be influenced predominantly by either the dose or the duration of metformin therapy. Hence, it is important to involve both the dose and duration of metformin therapy into the assessment of vitamin B12 deficiency.

Micronutrient deficiencies constitute a global health issue, particularly among countries in the Middle East .The World Health Organization (WHO) has divided this region into overlapping country clusters with regard to nutrition stages and dominant nutrition problems, including major risk factors and underlying causes, program interventions, and gaps in response to these problems.

Countries in early nutrition transition (e.g., Egypt, Jordan, Lebanon, Morocco, and Palestine) are typically characterized by a moderate prevalence of overweight and obesity, moderate levels of undernutrition in specific population groups, and widespread micronutrient deficiencies/inadequacies.

Metformin Usage Index is the product of the dose of metformin (mg) used and its duration divided by 1000. An index which incorporates both of these factors would not only be useful to understand the cumulative impact on vitamin B12 levels but also provide an objective threshold for initiating vitamin B12 supplementation .

So , the aim of this study is to assess the relationship between the dose and duration of metformin therapy with vitamin B12 levels using the "Metformin Usage Index" (MUI) in Egyptian type 2 diabetic patients where the incidence of nutritional deficiencies are not uncommom in order to formulate their appropriate management strategies .

The aim of our study is to evaluate the combined effect of both dose and duration of metformin therapy on vitamin B12 levels in Egyptian patients with type 2 diabetes mellitus (T2D).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

108

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Egypt
    • Manial
      • Cairo, Manial, Egypt, 11521
        • Recruiting
        • Cairo University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

108 patients aged 20 to 65 years old with controlled and uncontrolled type 2 DM

Description

Inclusion Criteria:

  • Men and women aged 20 to 65 years old with controlled and uncontrolled type 2 DM

Exclusion Criteria:

  • T2DM patients who are pregnant/lactating women,
  • newly diagnosed with T2DM (< 3 months),
  • who receive vitamin B12 supplementation or proton-pump inhibitors over the last 6 months,
  • alcoholics ,
  • known cases of malabsorption (gastrointestinal surgery, inflammatory bowel diseases and gluten allergy),
  • chronic kidney disease,
  • pernicious anemia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
metformin usage index and vitamin B12 level
Samples for correlation between metformin usage index and vitamin B1 level will be withdrawn from 108 type 2 diabetes patients
Other: sampling for diabetes control parameters
Intravenous blood withdrawal for a sample of fasting blood glucose (FBG), 2 hr postprandial blood glucose (2 hr -PPG), fasting lipids {total cholesterol (TC), triglycerides (TAG), low density lipoprotein cholesterol (LDL-C), high density lipoprotein cholesterol (HDL-C)}, glycosylated hemoglobin (Hb A1c) ,fasting insulin level and Vitamin B 12 levels
Other: Sampling for vitamin B12 level
Intravenous blood sampling for a sample of vitamin B12 level

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation between Metformin Usage Index and Vitamin B12 status among Egyptian patients with type 2 diabetes
Time Frame: 6 months
The relationship between MUI and vitamin B12 levels will be assessed among the studied groups
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • Ahmed MA, Muntingh G, Rheeder P (2016) Vitamin B12 deficiency in metformin-treated type-2 diabetes patients, prevalence and association with peripheral neuropathy. BMC Pharmacol Toxicol 17(1):44. https ://doi.org/10.1186/s4036 0-016-0088-3. Alvarez M, Sierra OR, Saavedra G, Moreno S (2019) Vitamin B12 deficiency and diabetic neuropathy in patients taking metformin: a cross-sectional study. Endocr Connect 8(10):1324- 1329. https ://doi.org/10.1530/EC-19-0382. Annani-Akollor ME, Addai-Mensah O, Fondjo LA, et al.(2019) Predominant complications of type 2 diabetes in kumasi: a 4-year retrospective cross-sectional study at a teaching hospital in Ghana. Medicina (B Aires). 2019;55(5): 125.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 5, 2021

Primary Completion (Anticipated)

September 1, 2022

Study Completion (Anticipated)

October 1, 2022

Study Registration Dates

First Submitted

April 28, 2021

First Submitted That Met QC Criteria

May 8, 2021

First Posted (Actual)

May 11, 2021

Study Record Updates

Last Update Posted (Actual)

March 24, 2022

Last Update Submitted That Met QC Criteria

March 22, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • N-25-2021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

not to share

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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