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Effects of Oral Magnesium Supplementation on Patients With Type 2 Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04636411
Recruitment Status : Recruiting
First Posted : November 19, 2020
Last Update Posted : November 19, 2020
Sponsor:
Collaborators:
Walaa Reda Abdel Fattah Mohamed Badr
Marwa Mostafa Ahmed
Moushira Hosny Ezzelarab Sayed
Nagwa Eid Sobhy Saad
Information provided by (Responsible Party):
Samar Fares, MD, Cairo University

Brief Summary:

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)

Condition or disease Intervention/treatment Phase
Type2 Diabetes Dietary Supplement: Oral Magnesium Supplementation Other: Standard Care for diabetic patients Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 74 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The study participants will be randomized into 2 groups (intervention and control group) to be studied simultaneously
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation of the Effects of Oral Magnesium Supplementation on Glycemic Control and Inflammation Among Patients With Type 2 Diabetes
Actual Study Start Date : November 1, 2020
Estimated Primary Completion Date : October 1, 2021
Estimated Study Completion Date : November 1, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Magnesium

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




Primary Outcome Measures :
  1. Glycemic control [ Time Frame: 3 months ]
    To determine the effect of oral Mg supplementation for diabetic patient on Glycemic control

  2. Inflammation [ Time Frame: 3 months ]
    To determine the effect of oral Mg supplementation for diabetic patient on inflammation (CRP)


Secondary Outcome Measures :
  1. Serum magnesium level [ Time Frame: 3 months ]
    To determine the effect of Mg supplementation for diabetic patient on serum Mg level

  2. Prevalence of hypomagnesemia [ Time Frame: up to 4 weeks ]
    To estimate prevalence of hypomagnesemia in patients with type 2 DM.

  3. 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).

  4. Total or ionized Mg [ Time Frame: 3 months ]
    Determine the more accurate measure for Mg in diabetic patient either total or ionized Mg



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04636411


Contacts
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Contact: Samar H Fares, Lecturer 01009403943 ext 002 Samar.fares@kasralainy.edu.eg
Contact: Walaa R Badr, Specialist 01111787218 ext 002 walaareda84@hotmail.com

Locations
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Egypt
Mokattam primary health care unit Recruiting
Cairo, Mokattam, Egypt, 11562
Contact: Walaa R Badr, Specialist    01111787218 ext 002    walaareda84@hotmail.com   
Sponsors and Collaborators
Samar Fares, MD
Walaa Reda Abdel Fattah Mohamed Badr
Marwa Mostafa Ahmed
Moushira Hosny Ezzelarab Sayed
Nagwa Eid Sobhy Saad
Investigators
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Principal Investigator: Nagwa E Saad, Professor Cairo University
Additional Information:
Publications:
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Responsible Party: Samar Fares, MD, Lecturer of family medicine, Cairo University
ClinicalTrials.gov Identifier: NCT04636411    
Other Study ID Numbers: MD-164-2020
First Posted: November 19, 2020    Key Record Dates
Last Update Posted: November 19, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The study data will be available upon reasonable request from central contact person
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: After finalizing the study
Access Criteria: The study data will be available upon reasonable request from central contact person

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Samar Fares, MD, Cairo University:
Oral Magnesium
Type 2 Diabetes
Diabetes Control
HbA1c
Inflammation
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases