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IRCT20151028024756N4 IRCT 2023-10-14 Esfahan University of Medical Sciences Effect of thiamine and magnesium sulfate in treatment of diabetes TMg Investigating the effect of magnesium and thiamine combination to improve hyperglycemia and insulin resistance in type 2 diabetic patients 2023-11-22 anticipated 100 Complete https://irct.ir/trial/71783 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: After obtaining a written consent and explaining how to conduct the research, the patients by using of rand function in Excel software divided into two groups (the patients and the treating physician and the person responsible for the statistical analysis do not know the type of drug), only one person who It directs people between two groups. It is aware of the study and replaces another person if one sample is removed, Blinding description: The doctor, the patient and the statistician do not know about the type of groupings and drugs. 2 Diabetes-Insulin resistance. Intervention 1: Intervention group: Type 2 diabetic patients received metformin and capsule containing 300 mg magnesium sulphate and 100 mg thiamin. Intervention 2: Control group: Type 2 diabetic patients received metformin and placebo. Yes - There is a plan to make this available What will be shared: After data analysis, the data will be presented as an article and a final report. Data will be made available to legal requesters after the information is de-identified When: After printing the articles and sending the final report to the vice president of research and technology of Isfahan University of Medical Sciences To whom: Vice President of Research and Technology of Isfahan University of Medical Sciences and Endocrine Research Center of Isfahan University of Medical Sciences Conditions: Expanding the research or repeating the research by other endocrinologists Where to obtain: Endocrine Research Center or Vice President of Research and Technology of Isfahan University of Medical Sciences How to obtain: After receiving the request, correspondence will be made with the responsible executive, Vice President of Research and Technology and Endocrine Research Center of Isfahan University of Medical Sciences Comments:
public Bijan Iraj
Hezar Jerib
Isfahan Iran (Islamic Republic of) 8174673461 009837929001 bijaniraj@gmail.com Esfahan University of Medical Sciences scientific Nepton Soltani
Hezar Jerib
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3792 9019 neptun.soltani@med.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Patients with a definitive diagnosis of type 2 diabetes for more than 5 years by a physician (plasma glucose level greater than 126 mg/dL and HbA1c between 6.5 and 8 percent at least 3 months before the start of the study) Men or women in the age range is over 18 years with a body mass index of 18.5 to 30 kg/m2 . 3 Patients taking metformin Being able to communicate and volunteer to participate in the research. Signature written consent Residence in Isfahan city The possibility of continuous monitoring of patients. 18 years 70 years Both Pregnancy and breastfeeding Smoking and alcohol consumption during study and in the last year Suffering from other underlying diseases such as severe liver failure, kidney failure (serum creatinine more than 4 mg/dL), severe cardiovascular diseases, stroke up to 3 months before the start of the research, cancer, inflammatory diseases, severe infection, and thyroid disorders. Taking drugs such as insulin, immunosuppressive drugs, anti-inflammatories. Taking medicinal supplements containing magnesium, thiamine or a history of allergy to these drugs. Patients with severe ketosis. Change in the type or dose of diabetes medication during the intervention. Patients with poor and inappropriate nutrition and with persistent anemia (hemoglobin less than 6 mg/dL). Patients who consume less than 90% of the tested medication will be excluded from the study Traveling for more than two weeks E11.01 Type 2 diabetes mellitus with hyperosmolarity with coma Treatment - Drugs Placebo Intervention group: Type 2 diabetic patients received metformin and capsule containing 300 mg magnesium sulphate and 100 mg thiamin Control group: Type 2 diabetic patients received metformin and placebo Fasting blood glucose-. Timepoint: Before intervention and every 3 months. Method of measurement: By using kit and according to the kit instructions. HbA1c. Timepoint: Before intervention and every 3 months. Method of measurement: By using kit and according to the kit instructions. HOMA-IR. Timepoint: Before intervention and every three months. Method of measurement: By using specific kits. GLUT4 gene expression. Timepoint: Before intervention and every three months. Method of measurement: By using specific kit. FOXO1 gene expressions. Timepoint: Before intervention and every three months. Method of measurement: By using specific kit. Esfahan University of Medical Sciences Approved 2023-10-02 Ethics committee of Isfahan University of Medical Sciences Hezar Jerib Isfahan Isfehan Iran (Islamic Republic of)