A comparative study on the effect of oral Magnesium supplementation versus placebo on Hypertension in patients with type 2 diabetes

Randomized allocation of patients with type 2 diabetes and hypertension to standard treatment with or without oral magnesium, with measurement of systolic and diastolic blood pressure

A total of 30 participants per group will be enrolled consecutively based on eligibility criteria. Sample size was calculated as 26 per group using G*Power 3.1.9.7 (effect size = 0.8, 80% power, 95% confidence) and increased to 30 per group to account for potential dropouts. Participants will be randomly assigned to receive either oral magnesium supplementation or placebo)

Patients with type 2 diabetes and hypertension attending the Internal Medicine Clinic of LOGHMAN Hakim Hospital (2025-2026) will be enrolled. Those on Valsartan/Amlodipine and insulin analogs will, after informed consent, be randomly assigned to standard treatment with or without oral magnesium. Follow-up occurs at weeks 4 and 8, with blood pressure measured using a manual manometer

Patients with type 2 diabetes and hypertension without prior gastrointestinal complications

Patients aged 30 to 70 years with type 2 diabetes (diagnosed according to ADA criteria) who are treated with insulin analogs and who also have high blood pressure and are treated with valsartan/amlodipine, if they do not meet the exclusion criteria will be included in the study after obtaining informed written consent. After randomization, patients are assigned to two groups receiving oral magnesium citrate and placebo, and their blood pressure is assessed at baseline, four and eight weeks later.

Systolic blood pressure; Diastolic blood pressure; Fasting blood glucose; HbA1c; Serum magnesium; Adverse events (diarrhea, hypotension, arrhythmia)

The steps of random assignment of patients to two experimental and control groups will be as follows: 1- Creating a random sequence of Random Sequence Generation will be done in the form of simple randomization and through the preparation and shuffling of cards. So that a number of cards will be prepared as the first group and the same number of cards will be prepared for the next groups. Then, by removing them, a card is taken out and its assignment is registered, and that card is returned to the other cards. Then the cards are dealt again and another card is drawn. This process will continue until reaching a random sequence according to the sample size. 2- Random allocation concealment will be done by placing the aforementioned cards inside Sequentially Numbered Sealed Opaque Envelopes (SNOSE). 3- People from the research team who are responsible for the above steps will not enter the other steps of the research, especially the examination of people in terms of the dependent variable.

either the intervention group (magnesium supplementation) or the control group (placebo). The magnesium supplement and placebo are identical in appearance and packaging and are coded accordingly. Investigators and healthcare personnel are aware of group allocation and are responsible for administering the intervention and patient follow-up. Access to the allocation codes by the Data Safety and Monitoring Committee, if established, will be permitted only when required for safety reasons. All participants provide written informed consent prior to enrollment.

All variables and information about participants can be shared after de-identifying people

At the time of publication

All treatment staff, researchers and people who intend to verify the data will be able to access the data

If the source is mentioned, the data will be made available to the requesters

Refer to the organizers of the plan or to Loghman Hakim Hospital in Tehran

The request is made by email or phone and the information will be sent in the form of e-mail