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IRCT20220305054199N1 IRCT 2022-11-01 Mazandaran University of Medical Sciences Effect of metformin in patients with concurrent asthma and metabolic syndrome Effect of metformin on outcomes of hyperglycemia, inflammatory markers, asthma control test (ACT) and spirometry in patients with concurrent asthma and metabolic syndrome 2022-04-03 anticipated 110 Complete https://irct.ir/trial/62400 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization in intervention and control groups will be done as block randomization in blocks of 4 by using the sealedenvelope website (online randomization website). The output of the software is A and B, one for intervention and the other one for control group. In this way, the samples are divided into two intervention and control groups. The second colleague communicates with the first colleague using central randomization based on the order in which the participants entered the study and asks about the random assignment of the participant to a specific group, Blinding description: Metformin or metformin placebo will be coded in sealed envelopes by a project partner, other than the treating physician. Placebo is designed as pills that are similar in shape, size and color to the original Metformin drug. 3 Condition 1: Asthma. Condition 2: Metabolic Syndrome. Intervention 1: Intervention group: Patients receiving standard treatment for severe asthma attacks, according to the GINA guideline, based on random allocation using blockade, are treated with metformin 500 mg in tablets. The drug will start by giving one pill on the first day and increase to one capsule twice a day on the third day. This dose will continue until the end of the three-month follow-up period. Intervention 2: Control group: According to the GINA guideline, patients receive standard treatment for severe asthma attacks based on random allocation using blockade treated with a Pharmed placebo in the same shape as metformin tablets. The placebo will start by giving one pill on the first day and increase to one capsule twice a day on the third day. This dose will continue until the end of the three-month follow-up period. Yes - There is a plan to make this available What will be shared: Due to the novelty of this study and the lack of other similar articles, for the sake of transparency of the study, the initial data of the project can be shared as an Excel file after de-identifying people. When: The data access period is six months after the results are published. To whom: Researchers working in academic and scientific institutions can access the data. Conditions: The use of these data in articles and scientific research is allowed. Where to obtain: To receive the data, send an email to hmehravaran@mazums.ac.ir, which belongs to Dr. Hossein Mehravaran. How to obtain: After sending the applicant's personal details and scientific background and information related to the study, including the purpose of the study, it will be checked and if approved, the information will be provided to the person. Comments:
public Hosein Mehravaran
Sari, AmirMazandarani Ave, Emam Hospital
Sari Iran (Islamic Republic of) 4816633131 +98 11 3337 3689 hmehravaran@mazums.ac.ir Mazandaran University of Medical Sciences scientific Hosein Mehravaran
Sari, AmirMazandarani Ave, Emam Hospital
Sari Iran (Islamic Republic of) 4816633131 +98 11 3337 3689 hmehravaran@mazums.ac.ir Mazandaran University of Medical Sciences Iran (Islamic Republic of) Patients with concurrent asthma and metabolic syndrome 18 years no limit Both Patients with COPD, hypercapnic respiratory failure, bronchiectasis and respiratory system cancers Patients with diabetes People at high risk of malnutrition Patients with renal failure with creatinine clearance less than 30 cc per minute Heart Failure class 4 Hemoglobinopathy includes thalassemia major and intermedia and sickle cell anemia severe liver failure Patient with severe sepsis Patient with cancer Treatment - Drugs Placebo Intervention group: Patients receiving standard treatment for severe asthma attacks, according to the GINA guideline, based on random allocation using blockade, are treated with metformin 500 mg in tablets. The drug will start by giving one pill on the first day and increase to one capsule twice a day on the third day. This dose will continue until the end of the three-month follow-up period. Control group: According to the GINA guideline, patients receive standard treatment for severe asthma attacks based on random allocation using blockade treated with a Pharmed placebo in the same shape as metformin tablets. The placebo will start by giving one pill on the first day and increase to one capsule twice a day on the third day. This dose will continue until the end of the three-month follow-up period. Capillary blood glucose concentration and HbA1C. Timepoint: Before meals and two hours after breakfast at the beginning of hospitalization and discharge and one and three months after discharge. Method of measurement: Using Pars Azmoon Kit. The rate of asthma attacks leads to emergency room visits and hospitalization. Timepoint: At the time of hospitalization and one and three months after hospitalization. Method of measurement: Asthma control test (ACT) and spirometry and clinical history. The rate of inflammatory markers. Timepoint: At the time of hospitalization and discharge and one and three months after discharge. Method of measurement: Measurement of C-reactive protein (CRP) levels. HbA1C. Timepoint: At the time of hospitalization and one and three months after hospitalization. Method of measurement: Using Pars Azmoon Kit. Body mass index. Timepoint: At the beginning of hospitalization and one and three months after starting metformin. Method of measurement: By a doctor. Mazandaran University of Medical Sciences Approved 2022-02-02 Ethics committee of Mazandaran University of Medical Sciences Sari Amir Mazandarani Ave, Emam Hospital Sari Mazandaran Iran (Islamic Republic of)