]>
IRCT20240520061850N1 IRCT 2024-11-09 Shiraz University of Medical Sciences Effect of metformin versus dapagliflozin in treatment of polycystic ovary syndrom. Effect of sodium-glucose co-transporter inhibitor on metabolic and hormonal profiles in polycystic ovary syndrome 2024-06-21 anticipated 100 Complete https://irct.ir/trial/77108 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Permuted block randomization Randomization method: The permutation block randomization method with blocks of four will be used. We assign different permutations to numbers 1 to 6 in the following order 1. AABB2. ABAB3. ABBA4. BBAA5. BABA6. BAAB Now, using the table of random numbers, we extract the numbers from the table and depending on whether one of the numbers 1 to 6 comes, select each of the blocks assigned to these numbers until 36 blocks of 4 are selected. If the numbers zero, 7, 8, and 9 come, we ignore them and continue this order to provide a complete list for the entire sample size. 2 Polycystic ovary syndrome Based on Rotterdam Criteria. Intervention 1: Intervention group :Treatment of women with polycystic ovary syndrome aged 18-45 with a body mass index greater than or equal to 25, with metformin 500 mg TID for 3 months. Metformin is an oral hypoglycemic agent and belongs to the group of biguanides, which has been proven to play a role in the treatment of polycystic ovary syndrome. Educational sessions for patients of this group to explain the side effects and how to take the medicine are held at the first visit and then once a month. this drug is produced by Shafa Pharmaceutical Company. Intervention 2: Intervention group: Treatment of women with polycystic ovary syndrome aged 18-45 with a body mass index greater than or equal to 25, with dapagliflozin 10 md daily for 3 months. This blood sugar lowering drug is one of the drugs that inhibit the sodium-glucose transporter in the kidney, which lowers blood sugar by excreting glucose in the urine. Educational sessions for patients of this group to explain the side effects and how to take the medicine are held at the first visit and then once a month. This drug is produced by the Innovative Pharmaceutical Company of Kimia, under the name of Faxibet. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information.
public Farnaz Kamali Haghighi Shirazi
Nemazee Sq, Nemazee Hospital, Endocrinology and Metabolism Research Center
Shiraz Iran (Islamic Republic of) 7193613311 +98 71 3647 4332 F.kamali85@gmail.com Shiraz University of Medical Sciences scientific Farnaz Kamali Haghighi Shirazi
Nemazee Sq., Nemazee Hospital, Endocrinology and Metabolism Research Center
Shiraz Iran (Islamic Republic of) 7193613311 +98 917 700 1435 F.kamali85@gmail.com Shiraz University of Medical Sciences Iran (Islamic Republic of) Women aged 18-45 with polycystic ovary syndrome with body mass index more than 25 18 years 45 years Female Cushing syndrome inadequately controlled thyroid disease. androgen-secreting tumor pregnancy or intention to become pregnant Breast feeding documented use of oral hormonal contraceptives and hormone-releasing implants, clomiphene citrate or estrogen modulators, gonadotropin-releasing hormone (GnRH) modulators diagnosis of diabetes and use of antidiabetic agent congenital adrenal hyperplasia due to 21-hydroxilase defficiency hyperprolactinemia, age<18 year or >45 year, E28.2 Polycystic ovarian syndrome Treatment - Drugs Treatment - Drugs Intervention group :Treatment of women with polycystic ovary syndrome aged 18-45 with a body mass index greater than or equal to 25, with metformin 500 mg TID for 3 months. Metformin is an oral hypoglycemic agent and belongs to the group of biguanides, which has been proven to play a role in the treatment of polycystic ovary syndrome. Educational sessions for patients of this group to explain the side effects and how to take the medicine are held at the first visit and then once a month. this drug is produced by Shafa Pharmaceutical Company. Intervention group: Treatment of women with polycystic ovary syndrome aged 18-45 with a body mass index greater than or equal to 25, with dapagliflozin 10 md daily for 3 months. This blood sugar lowering drug is one of the drugs that inhibit the sodium-glucose transporter in the kidney, which lowers blood sugar by excreting glucose in the urine. Educational sessions for patients of this group to explain the side effects and how to take the medicine are held at the first visit and then once a month. This drug is produced by the Innovative Pharmaceutical Company of Kimia, under the name of Faxibet. The percentage of people with fasting blood sugar >/equal to 100. Timepoint: Measuring fasting blood sugar at the beginning of the study and after 12 weeks of using metformin or dapagliflozin. Method of measurement: Fasting venous blood sampling. Blood pressure measurement. Timepoint: Measuring blood pressure at the beginning of the study and after 12 weeks of using metformin or dapagliflozin. Method of measurement: Sphygmomonometer. Fasting plasma lipid level. Timepoint: Fasting plasma lipid measurement at the beginning of the study and after 12 weeks of using metformin or dapagliflozin. Method of measurement: Fasting venous blood sampling. Fasting plasma insulin level. Timepoint: Fasting plasma insulin level measurement at the beginning of the study and after 12 weeks of using metformin or dapagliflozin. Method of measurement: Fasting venous blood sampling. Fasting plasma androstenedione level. Timepoint: Fasting plasma androstenedione level measurement at the beginning of the study and after 12 weeks of using metformin or dapagliflozin. Method of measurement: Fasting venous blood sampling. Total plasma testosterone. Timepoint: Fasting plasma testosterone level measurement at the beginning of the study and after 12 weeks of using metformin or dapagliflozin. Method of measurement: Fasting venous blood sampling. C-reactive protein plasma level. Timepoint: Measuring the plasma level of C-reactive protein at the beginning of the study and after 12 weeks of using metformin or dapagliflozin. Method of measurement: Fasting venous blood sampling. Measurement of waist/Hip ratio. Timepoint: Measuring waist/Hip ratio at the beginning of the study and after 12 weeks of using metformin or dapagliflozin. Method of measurement: Meter. Body mass index. Timepoint: Measuring body mass index at the beginning of the study and after 12 weeks of using metformin or dapagliflozin. Method of measurement: Meter and scale. Shiraz University of Medical Sciences Approved 2024-05-20 Ethnic Committee of Shiraz University of Medical Sciences Office of Internal Medicine Department, Zand Blvd., Nemazee Hospital Shiraz Fars Iran (Islamic Republic of)