Type 2 DiabetesNCT05774015
Effect of Oral Magnesium Supplementation on Type II Diabetes Mellitus Guided by Serum Ionized Magnesium Level
A study testing Magnesium Oxide tablet 500 mg in people with Type 2 Diabetes and Magnesium Disorder, run by Sultan Qaboos University at 1 site in Oman.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes, Magnesium Disorder
- What is being tested?
- Magnesium Oxide tablet 500 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 247 participants
- Where
- 1 siteOman
- Study dates
- 25 Sep 2023to 11 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults (≥18 years old).
- Treated with oral hypoglycemic agents (OHA) ± insulin regimen.
- Had HbA1c ≥ 7% in the last 3 months
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- Magnesium Oxide tablet 500 mg
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnesium Oxide tablet 500 mgDietary supplement
To supplement T2DM with Mg oxide tablets (500 mg total, 302 mg elemental) regardless on their magnesium level
| Study group | Role | What they receive |
|---|---|---|
| Interventional group (Mg oxide supplementation): | Active comparator | 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. Receives: Dietary Supplement: Magnesium Oxide tablet 500 mg |
| Control group (placebo tablets) | Placebo comparator | 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. Receives: Dietary Supplement: Magnesium Oxide tablet 500 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3-month and 12-month
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.
Measured: 3-month and 12-month
Secondary outcomes (5)
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.
Measured: 3-month and 12-month
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.
Measured: 3-month and 12-month
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.
Measured: 3-month and 12-month
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.
Measured: 3-month and 12-month
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.
Measured: 3-month and 12-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2023
- Study start25 Sep 2023
- Primary completion30 Sep 2024
- Study completion11 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A prospective double-blind RCT with a control group and an interventional group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 247 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sultan Qaboos University
- Sponsor type
- University, hospital or other
- Collaborators
- Nova Biomedical
- Responsible party
- Principal investigator, Prof. Mohammed Al za'abi, Sultan Qaboos University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05774015
- Sponsor's protocol ID
- SQUH-ionized magnesium
- Status last verified
- Sep 2025
- First submitted
- 7 Mar 2023
- Last updated
- 18 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: the whole IPD can be shared
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05774015
- Acronym / sponsor ID
- SQUH-ionized magnesium
- Conditions
- Type 2 Diabetes, Magnesium Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 247 participants (actual)
- Lead sponsor
- Sultan Qaboos UniversityUniversity, hospital or other
- Collaborators
- Nova Biomedical
- Study start
- 25 Sep 2023 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 11 Sep 2025 (actual)
- First posted
- 17 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A prospective double-blind RCT with a control group and an interventional group
| Arm | Type | Receives |
|---|---|---|
| Interventional group (Mg oxide supplementation): | Active comparator | Dietary Supplement: Magnesium Oxide tablet 500 mgInterventional 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. |
| Control group (placebo tablets) | Placebo comparator | Dietary Supplement: Magnesium Oxide tablet 500 mgControl 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults (≥18 years old).
- Treated with oral hypoglycemic agents (OHA) ± insulin regimen.
- Had HbA1c ≥ 7% in the last 3 months
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnesium Oxide tablet 500 mgTo supplement T2DM with Mg oxide tablets (500 mg total, 302 mg elemental) regardless on their magnesium level | Dietary supplement | Control group (placebo tablets), Interventional group (Mg oxide supplementation): |
Primary outcome
Glycated hemoglobin (HbA1c%)
Time frame: 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)
Time frame: 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.
5 secondary outcomes
Emergency department (ED) visits, hospital admission, and length of hospital stay (LOS)
Time frame: 3-month and 12-month
Total dosage of insulin regimen
Time frame: 3-month and 12-month
Blood pressure
Time frame: 3-month and 12-month
lipid profile
Time frame: 3-month and 12-month
Serum creatinine
Time frame: 3-month and 12-month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2025.
- Individual participant dataSharing planned: Yes. the whole IPD can be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magnesium Oxide tablet 500 mg in people with Type 2 Diabetes and Magnesium Disorder, run by Sultan Qaboos University at 1 site in Oman.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Oman. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glycated hemoglobin (HbA1c%) (time frame: 3-month and 12-month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2025.