Effect of Oral Magnesium Supplementation on Type II Diabetes Mellitus Guided by Serum Ionized Magnesium Level

NCT05774015 | Completed

• 1 other identifier: SQUH-ionized magnesium
• Study Type: interventional
• Target: 247
• Locations: 1 country
• Sites: 1

Brief Summary

Studies have shown that type 2 diabetic patients (T2DM) may have low serum magnesium levels leading to poor control and outcome of the disease. Supplementation with Mg might improve overall diabetic control and disease outcome. However, there is yet no consensus on whether the ionized (iMg) or the total Mg (tMg) level should be used as a basis to determine the status of Mg in the blood. Recently it was shown that iMg may correlate better with diabetes control than tMg. Therefore, Mg supplements to diabetic patients may improve their disease status. Unfortunately, and to the best of our knowledge all of the available trials on Mg supplementation guided by iMg levels were conducted on healthy volunteers rather than T2DM patients, and they were all for a short period of time (10 days to 10 weeks). Here we hypothesize that supplementations of T2DM patients with Mg based on serum iMg levels correlate better with diabetes control and prognosis. Such hypothesis is supported by a retrospective study that concluded that iMg correlate better with BP control than tMg. In addition, another trial that investigated the effects of three Mg dietary supplements; Mg oxide, Mg citrate and Mg carbonate on healthy female young adults, showed that only Mg oxide led to an increase in the levels of iMg and tMg concentrations when compared to baseline. Furthermore, a case-control study on older diabetic patients revealed a significant association between iMg and HbA1c. This study aims to investigate the effect of supplementing Mg oxide tablets versus placebo tablets guided by serum iMg levels in T2DM patients with or without hypomagnesemia on diabetic control and prognosis.

Conditions

Type 2 Diabetes; Magnesium Disorder

Outcome Measures

Primary Outcomes (2)

• Glycated hemoglobin (HbA1c%)

  To evaluate the reduction in HbA1c% levels after 3 and 12 months of Mg supplementation versus placebo between the interventional group verse the control group.

  3-month and 12-month

• Fasting Blood Glucose (FBG)

  To evaluate the reduction in FBG levels after 3 and 12 months of Mg supplementation versus placebo between the interventional group verse the control group.

  3-month and 12-month

Secondary Outcomes (5)

• Emergency department (ED) visits, hospital admission, and length of hospital stay (LOS)

  3-month and 12-month

• Total dosage of insulin regimen

  3-month and 12-month

• Blood pressure

  3-month and 12-month

• lipid profile

  3-month and 12-month

• Serum creatinine

  3-month and 12-month

Study Arms (2)

Interventional group (Mg oxide supplementation):

ACTIVE COMPARATOR

Interventional group (Mg oxide supplementation): Patients in this group will receive Mg oxide tablet 500 mg (302 mg elemental), with a dosage regimen of 1 table once daily as per the recommended range of the daily dose (from 250 to 500 mg elemental) (29, 31, 41, 45). Tablets should be taken with food and 2 hrs. apart from other medications for 12 consecutive months.

Dietary Supplement: Magnesium Oxide tablet 500 mg

Control group (placebo tablets)

PLACEBO COMPARATOR

Control group (placebo tablets): Patients in this group will receive placebo tablets labeled as 500 mg (302 mg elemental), with a dosage regimen of 1 tablet once daily. Tablets should be taken with food and 2 hrs. apart from other medications for 12 consecutive months.

Dietary Supplement: Magnesium Oxide tablet 500 mg

Interventions

Magnesium Oxide tablet 500 mg DIETARY_SUPPLEMENT

To supplement T2DM with Mg oxide tablets (500 mg total, 302 mg elemental) regardless on their magnesium level

Control group (placebo tablets); Interventional group (Mg oxide supplementation):

Eligibility Criteria

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

You may qualify if:

• Adults (≥18 years old).
• Treated with oral hypoglycemic agents (OHA) ± insulin regimen.
• Had HbA1c ≥ 7% in the last 3 months

You may not qualify if:

• HbA1c of \< 7%.
• Fully dependent patients as per clinical frailty score
• End stage renal disease (creatinine clearances (CrCl) at \< 10ml/min)
• With neuromuscular disease
• With active solid or hematological malignancies.
• With cognitive disorders.
• With the following regular medications (baloxavir marboxil, calcium/sodium polystyrene sulfate, raltegravir, or unithiol) due to X category drug-drug interaction (contraindicated combinations) when given concurrently Mg oxide

Sponsors & Collaborators

• Sultan Qaboos University: lead
• Nova Biomedical: collaborator

Study Sites (1)

Mohammed AlZa'abi

Muscat, Oman

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Magnesium Oxide

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Magnesium Compounds; Inorganic Chemicals; Oxides; Oxygen Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The Mg oxide tablets or placebo tablets (a total of 4 bottles, 90 tablets in each coded bottle) will be provided for each participant during the study period. The 4 bottles for each participant will be per-coded to match the randomization labels to ensure a double-blinded process
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: A prospective double-blind RCT with a control group and an interventional group

Study Record Dates

• First Submitted: March 7, 2023
• First Posted: March 17, 2023
• Study Start: September 25, 2023
• Primary Completion: September 30, 2024
• Study Completion: September 11, 2025
• Last Updated: September 18, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: no limits

Locations

OM (1)