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

Type 2 Diabetes Clinical Trial

Official title:

The Effect of Oral Magnesium Supplementation on The Control and Outcomes of Type II Diabetes Mellitus Guided by Serum Ionized Magnesium Level: A Double-Blind Randomized Control Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05774015
• Other study ID #: SQUH-ionized magnesium
• Status: Recruiting
• Phase: N/A
• Start date: September 25, 2023
• Est. completion date: February 2025

Study information

• Verified date: November 2023
• Source: Sultan Qaboos University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: February 2025
• Est. primary completion date: February 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Magnesium Disorder
• Type 2 Diabetes

Intervention

Dietary Supplement:
• Magnesium Oxide tablet 500 mg
To supplement T2DM with Mg oxide tablets (500 mg total, 302 mg elemental) regardless on their magnesium level

Locations

Country	Name	City	State
Oman	Mohammed AlZa'abi	Muscat

Sponsors (3)

Lead Sponsor	Collaborator
Sultan Qaboos University	Karolinska Institutet, Nova Biomedical

Country where clinical trial is conducted

Oman, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Emergency department (ED) visits, hospital admission, and length of hospital stay (LOS)	To determine the rate of ED visits, hospital admission, and LOS after 3 months and 12 months of Mg supplementation between the interventional group verse the control group.	3-month and 12-month
Secondary	Total dosage of insulin regimen	To evaluate the pattern of total dosage adjustment in the insulin regimen after 3 months and 12 months of Mg supplementation versus placebo between the interventional group verse the control group.	3-month and 12-month
Secondary	Blood pressure	To evaluate the reduction BP measurement after 3 months and 12 months of Mg supplementation versus placebo between the interventional group verse the control group.	3-month and 12-month
Secondary	lipid profile	To evaluate the reduction in lipid profile after 3 and 12 months of Mg supplementation versus placebo between the interventional group verse the control group.	3-month and 12-month
Secondary	Serum creatinine	To evaluate the rate of changes in serum creatinine after 3 and 12 months of Mg supplementation versus placebo between the interventional group verse the control group.	3-month and 12-month