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IRCT20230522058258N2 IRCT 2026-01-02 Shahid Beheshti University of Medical Sciences The effect of oral Magnesium supplementation on Hypertension in patients with type 2 diabetes HTN A comparative study on the effect of oral Magnesium supplementation versus placebo on Hypertension in patients with type 2 diabetes 2026-01-04 anticipated 60 Complete https://irct.ir/trial/88047 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Diagnostic, Randomization description: 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, Blinding description: 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. 3 Hypertension. Intervention 1: Intervention group: They are treated with 300 mg of oral magnesium daily for 2 months. Intervention 2: Control group: they are treated with a placebo for 2 months. Yes - There is a plan to make this available What will be shared: All variables and information about participants can be shared after de-identifying people When: At the time of publication To whom: All treatment staff, researchers and people who intend to verify the data will be able to access the data Conditions: If the source is mentioned, the data will be made available to the requesters Where to obtain: Refer to the organizers of the plan or to Loghman Hakim Hospital in Tehran How to obtain: The request is made by email or phone and the information will be sent in the form of e-mail Comments:
public Arezoo Ranjbar Arani
Loghman Hakim Hospital, Kamali St., South Kargar Ave.
تهران Iran (Islamic Republic of) 1333625445 +98 21 5541 7243 drranjbar.ar@gmail.com Shahid Beheshti University of Medical Sciences scientific Arezoo Ranjbar Arani
Loghman hakim Hospital, Kamali Street, South Karegar Avenue
تهران Iran (Islamic Republic of) 1333625445 +98 21 5541 9005 drranjbar.ar@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Diagnosis of type 2 diabetes mellitus according to the American Diabetes Association (ADA) criteria Controlled or uncontrolled hypertension under pharmacological treatment Provision of written informed consent Presence of severe renal disease (eGFR < 30 ml/min/1.73 m²) Presence of heart failure classified as New York Heart Association (NYHA) class III or IV History of magnesium supplementation or use of medications affecting serum magnesium levels Systolic blood pressure < 90 mmHg or blood pressure ≥ 160/90 mmHg at baseline requiring therapeutic intervention or medication adjustment Pregnancy Presence of gastrointestinal disorders that impair magnesium absorption 30 years 70 years Both I10 Essential (primary) hypertension Treatment - Drugs Placebo Intervention group: They are treated with 300 mg of oral magnesium daily for 2 months Control group: they are treated with a placebo for 2 months. Systolic Blood Pressure. Timepoint: Before the intervention and 1 and 2 months after the intervention. Method of measurement: Sphygmomanometer. Diastolic blood pressure. Timepoint: Before the intervention and 1 and 2 months after the intervention. Method of measurement: Sphygmomanometer. Shahid Beheshti University of Medical Sciences Approved 2025-12-09 Ethics committee of Sahid Beheshti University of Medical Sciences Loqman Hakim hospital - special St. - Lashgar intersection تهران Tehran Iran (Islamic Republic of)