NCT05774015Completed
Effect of Oral Magnesium Supplementation on Type II Diabetes Mellitus Guided by Serum Ionized Magnesium Level
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
Source: ClinicalTrials.gov · Last updated 18 Sept 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 247 (actual)
- First submitted
- 7 Mar 2023
- Start date
- 25 Sept 2023
- Primary completion date
- 30 Sept 2024
- Lead sponsor
- Sultan Qaboos University
- Diseases
- Type 2 diabetes
- NCT number
- NCT05774015
What you commit to
- Study type: Interventional
- Participants enrolled: 247
- From 25 Sept 2023 to the primary completion date, 30 Sept 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- With neuromuscular disease
- With active solid or hematological malignancies.
- With cognitive disorders.
Lab values
- HbA1c of \< 7%.
- End stage renal disease (creatinine clearances (CrCl) at \< 10ml/min)
- 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
Other
- Fully dependent patients as per clinical frailty score
Who the study is looking for
- Adults (≥18 years old).
- Treated with oral hypoglycemic agents (OHA) ± insulin regimen.
- Had HbA1c ≥ 7% in the last 3 months
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Mohammed AlZa'abi Coordinator of this site? Confirm its status | Muscat | Oman | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.