The effectiveness of oral magnesium administration on blood sugar, glycosylated hemoglobin, and lipid profile parameters of patients with type 1 diabetes

The effectiveness of oral magnesium administration on glycemic and metabolic control of patients with type 1 diabetes

Randomized(By assigning coded envelopes), Controlled, double-blinding clinical trial, with the parallel groups, Phase 3 on 120 patients

In this randomized double-blind clinical trial study, 120 eligible patients, referring to Imam Hossein Hospital of Isfahan, will be included in the study and will be randomly divided into two groups (each group in two sections of diabetic patients with and without overweight and obesity). Oral magnesium sachets are prescribed for the intervention group and the placebo for the control group. The intervention will be performed in such a way that the patient, the researcher, and the statistical analyst will have no knowledge of the type of intervention. Then the blood parameters, lipidemia, and body mass index of the patients before and after the intervention will be compared between the groups.

The inclusion criteria for the study include having type 1 diabetes, age range from 6 to 18 years, and having consent to participate in the study; Exclusion criteria include having a history of sensitivity to magnesium compounds, suffering from chronic diseases, using special drugs other than insulin, and using calcium-containing compounds.

Control group: For patients in this group, the placebo (in the form of sachets) is prescribed daily for 6 months. Intervention group: For patients in this group, oral magnesium sachets are prescribed daily according to the standard instructions(according to the age of the child), for 6 months.

Blood sugar; Glycosylated hemoglobin; High-density lipoprotein cholesterol (HDL); Low-density lipoprotein cholesterol (LDL); Body mass index(BMI)

First, 60 eligible to enter study patients with type 1 diabetes, who are overweight or obese, are selected non-randomly. Then the letter A is written on 30 leaves and the letter B is written on 30 leaves and each is placed in an envelope. Then each patient is asked to choose one envelope from among the envelopes. Then,60 eligible to enter study patients with type 1 diabetes, who are not overweight or obese are selected non-randomly. Then the letter C is written on 30 leaves and the letter D is written on 30 leaves and each is placed in an envelope. Then each patient is asked to choose one envelope from among the envelopes. In this way, according to the envelope selected without the researcher's intervention, the patients will be randomly assigned to one of the intervention and control groups.

In this study, magnesium sulfate and the placebo are prepared by the pharmacist in the same shape, size, and color and will be marked with A and B labels and provided to the researcher. He/She also prescribe them without knowing the type of each medicine. Therefore, the patient, the Investigator, the person recording the clinical and basic information of the patients as well as the statistical analyst will not be aware of the type of intervention.