Magnesium Disorder, Type 2 Diabetes
Conditions
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.
Interventions
DIETARY_SUPPLEMENTMagnesium Oxide tablet 500 mg
To supplement T2DM with Mg oxide tablets (500 mg total, 302 mg elemental) regardless on their magnesium level
Sponsors
Nova Biomedical
Sultan Qaboos University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
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
Intervention model description
A prospective double-blind RCT with a control group and an interventional group
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Glycated hemoglobin (HbA1c%) | 3-month and 12-month | 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. |
| Fasting Blood Glucose (FBG) | 3-month and 12-month | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Blood pressure | 3-month and 12-month | 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. |
| Emergency department (ED) visits, hospital admission, and length of hospital stay (LOS) | 3-month and 12-month | 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. |
| Serum creatinine | 3-month and 12-month | 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. |
| lipid profile | 3-month and 12-month | 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. |
| Total dosage of insulin regimen | 3-month and 12-month | 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. |
Countries
Oman
Outcome results
None listed