Effects of Oral Magnesium Supplementation on Patients With Type 2 Diabetes

February 6, 2024 updated by: Samar Fares, MD

Evaluation of the Effects of Oral Magnesium Supplementation on Glycemic Control and Inflammation Among Patients With Type 2 Diabetes

A total of 74 Adult Patients with type 2 diabetes mellitus (T2D) will be enrolled and randomized into 2 groups. The intervention group will receive oral magnesium (Mg) supplementation. The study objectives are:

  1. To estimate level of Mg (total and ionized) in patient with type 2 DM.
  2. To determine the effect of Mg supplementation for diabetic patient on serum Mg level, glycemic control and level of inflammation.
  3. To assess the correlation between serum Mg level and glycemic control and level of inflammatory mediators (CRP)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A total of 74 Adult Patients of both genders who had been diagnosed with T2D and are on oral anti-hyperglycemic drug and their HbA1C between 7and 8 %, will be enrolled in the study. Initially the study protocol will be explained & informed written consent will be obtained from all participants. All subjects will be evaluated to ensure that they meet the eligibility criteria through: Full history taking, complete physical examination and investigations. the intervention group will receive oral magnesium (Mg) supplementation for 3 months (250 mg of elemental magnesium daily). The primary outcome is to determine the effect of Mg supplementation for diabetic patient on serum Mg level, glycemic control and level of inflammation.

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Phase 3

Contacts and Locations

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

Study Locations

  • Egypt
    • Mokattam
      • Cairo, Mokattam, Egypt, 11562
        • Mokattam primary health care unit

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients with type 2 diabetes with HbA1C between 7 and 8%.
  • Both genders will be included in this study.

Exclusion Criteria:

  • Patients on insulin.

    • Patients on diuretics or angiotensin-converting enzyme inhibitors in the last 2 weeks.
    • Patients taking Mg containing supplements within 3 months.
    • Patients with significant gastrointestinal disorders (eg, chronic diarrhea).
    • Patients with impaired renal functions (eGFR< 60 mL/min).
    • Heart block or heart failure
    • Patients treated with aldosterone antagonists.
    • Pregnant patients
    • Patients with evidence of infection.
    • Patients with chronic inflammatory conditions eg, SLE

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention group
This group group will receive oral magnesium supplementation (250 mg of elemental magnesium daily for three months) plus the standard care for diabetic patients
Dietary supplement: Oral Magnesium Supplementation
250 mg of elemental magnesium daily for three months
Other: Standard Care for diabetic patients
Health education, oral antihyperglycemic medications according to American Diabetes Association (ADA) guidelines
Active Comparator: Control group
This group will receive the standard care for diabetic patients
Other: Standard Care for diabetic patients
Health education, oral antihyperglycemic medications according to American Diabetes Association (ADA) guidelines

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Glycemic control
Time Frame: 3 months
To determine the effect of oral Mg supplementation for diabetic patient on Glycemic control
3 months
Inflammation
Time Frame: 3 months
To determine the effect of oral Mg supplementation for diabetic patient on inflammation (CRP)
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum magnesium level
Time Frame: 3 months
To determine the effect of Mg supplementation for diabetic patient on serum Mg level
3 months
Prevalence of hypomagnesemia
Time Frame: up to 4 weeks
To estimate prevalence of hypomagnesemia in patients with type 2 DM.
up to 4 weeks
Correlation of serum Mg level
Time Frame: up to 4 weeks
To assess the correlation between serum Mg level and glycemic control and level of inflammatory mediators (CRP).
up to 4 weeks
Total or ionized Mg
Time Frame: 3 months
Determine the more accurate measure for Mg in diabetic patient either total or ionized Mg
3 months

Collaborators and Investigators

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

Sponsor

Samar Fares, MD

Collaborators

Walaa Reda Abdel Fattah Mohamed Badr
Marwa Mostafa Ahmed
Moushira Hosny Ezzelarab Sayed
Nagwa Eid Sobhy Saad

Investigators

  • Principal Investigator: Nagwa E Saad, Professor, 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

Helpful Links

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)

November 1, 2020

Primary Completion (Actual)

October 31, 2021

Study Completion (Actual)

December 31, 2021

Study Registration Dates

First Submitted

November 8, 2020

First Submitted That Met QC Criteria

November 13, 2020

First Posted (Actual)

November 19, 2020

Study Record Updates

Last Update Posted (Actual)

February 7, 2024

Last Update Submitted That Met QC Criteria

February 6, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MD-164-2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The study data will be available upon reasonable request from central contact person

IPD Sharing Time Frame

After finalizing the study

IPD Sharing Access Criteria

The study data will be available upon reasonable request from central contact person

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

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.

Clinical Trials on Type2 Diabetes

Clinical Trials on Oral Magnesium Supplementation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Myanmar

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe