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IRCT20230930059564N1 IRCT 2023-11-20 Shahid Beheshti University of Medical Sciences Investigating the effect of metformin on vascular function and cardiovascular risk factors in children and adolescents with type 1 diabetes Investigating the effect of metformin on vascular function and cardiovascular risk factors in children and adolescents with type 1 diabetes: a randomized, double-blind clinical trial 2023-12-21 anticipated 52 Complete https://irct.ir/trial/72863 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization will be done by block allocation. The method of randomization will be such that 13 blocks of four will be considered using the software to equalize the distribution of people in two groups, and then random allocation of people in each block will be done to intervention and control groups, Blinding description: This study will be double-blindness, so that researchers and all participants are unaware of intervention and control groups. 4 Type 1 diabetes. Intervention 1: Intervention group: receiving 500 mg metformin twice a day for 6 months. Intervention 2: Control group: receiving 500 mg placebo twice a day for 6 months. Yes - There is a plan to make this available What will be shared: Information on the main implications can be shared at the end of the study. When: The access period will be 6 months after the results are published. To whom: The data from this study will be available only to researchers working in academic and scientific institutions. Conditions: 6 months after the publication of the articles obtained from the data of this project, at the request of the person in charge of the project and his consent, the study data can be made available to researchers. Where to obtain: Applicants can contact the responsible author via the following email to obtain the required data. mosalladr@sbmu.ac.ir How to obtain: Applicants will be able to access the study data by sending an email to the responsible author within a maximum of one week. Comments:
public Asieh Mosalanejad
No. 1057, Mofid Children's Hospital, above Hosseinieh Ershad, Shariati St., Tehran, Iran.
Tehran Iran (Islamic Republic of) 1546815514 +98 21 2222 7021 mosalladr@sbmu.ac.ir Shahid Beheshti University of Medical Sciences scientific Asieh Mosallanejad
No. 1057, Mofid Children's Hospital, above Hosseinieh Ershad, Shariati St., Tehran, Iran.
Tehran Iran (Islamic Republic of) 1546815514 +98 21 2222 7021 mosalladr@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Age 8 to 21 years Body mass index (BMI) percentile for ages 5 to 85 Receiving insulin (Recombinant, NPH, Regular) Not using metformin in the past year Diagnosis of type 1 diabetes (at least 5 years) Not suffering from diabetic ketoacidosis or hypoglycemia (blood sugar level less than 50 mg/dL) in the last 6 months Not using metformin in the past year Not taking anti-hypertensive, anti-inflammatory, anti-coagulant, fat-reducing, weight-reducing and antioxidant drugs in the last 6 months Willingness to participate in the plan 8 years 21 years Both Pregnant or lactating people Having severe side effects of metformin (lactic acidosis, severe digestive problems) Suffering from endocrine disorders such as hypothyroidism Any acute illness that leads to hospitalization of the patient Lack of compliance (the patient does not want to continue participating in the study for any reason) E10 Type 1 diabetes mellitus Treatment - Drugs Placebo Intervention group: receiving 500 mg metformin twice a day for 6 months Control group: receiving 500 mg placebo twice a day for 6 months Flow-mediated dilatation. Timepoint: At the beginning of the study and at the end of 6 month. Method of measurement: Sonography. Glycated hemoglobin A1C. Timepoint: At the beginning of the study and at the end of 6 month. Method of measurement: Elisa kit. Triglyceride. Timepoint: At the beginning of the study and at the end of 6 month. Method of measurement: Elisa kit. Fasting blood sauger. Timepoint: At the beginning of the study and at the end of 6 month. Method of measurement: Elisa kit. Body mass index. Timepoint: At the beginning of the study and at the end of 6 month. Method of measurement: Calculate weight divided by height (cm) to the power of two. Shahid Beheshti University of Medical Sciences Approved 2023-09-22 Ethic Committee of Shahid beheshti University of Medical Sciences Arabi Ave, Daneshjoo Blvd, Velenjak Tehran Tehran Iran (Islamic Republic of)