Clinical trial NCT05774015: Effect of Oral Magnesium Supplementation on Type II Diabetes Mellitus Guided by Serum Ionized Magnesium Level
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Type 2 Diabetes
Magnesium Disorder
Lead sponsor: Sultan Qaboos University
Sponsor class: OTHER
Collaborators: name: Karolinska Institutet
name: Nova Biomedical
First posted: 2023-03-17
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A prospective double-blind RCT with a control group and an interventional group
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: Glycated hemoglobin (HbA1c%)
timeFrame: 3-month and 12-month
measure: Fasting Blood Glucose (FBG)
timeFrame: 3-month and 12-month
Secondary outcomes:
measure: Emergency department (ED) visits, hospital admission, and length of hospital stay (LOS)
timeFrame: 3-month and 12-month
measure: Total dosage of insulin regimen
timeFrame: 3-month and 12-month
measure: Blood pressure
timeFrame: 3-month and 12-month
measure: lipid profile
timeFrame: 3-month and 12-month
measure: Serum creatinine
timeFrame: 3-month and 12-month
Other outcomes:
Locations:
city: Muscat
country: Oman
facility: Mohammed AlZa'abi
Study officials:
References: