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

NCT ID: NCT05774015

Last Updated: 2025-09-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 247 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-25
• Study Completion Date: 2025-09-11

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: QUADRUPLE

Study Groups

Interventional group (Mg oxide supplementation):

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.

Group Type: ACTIVE_COMPARATOR

Magnesium Oxide tablet 500 mg

Intervention Type: DIETARY_SUPPLEMENT

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

Control group (placebo tablets)

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.

Group Type: PLACEBO_COMPARATOR

Magnesium Oxide tablet 500 mg

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

Magnesium Oxide tablet 500 mg

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

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nova Biomedical

INDUSTRY

Sponsor Role: collaborator

Sultan Qaboos University

OTHER

Sponsor Role: lead

Responsible Party

Prof. Mohammed Al za'abi

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Mohammed AlZa'abi

Muscat, , Oman

Countries

Oman

Other Identifiers

SQUH-ionized magnesium

Identifier Type: -

Identifier Source: org_study_id