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IRCT20100706004329N9 IRCT 2020-12-15 Tehran University of Medical Sciences The effect of metformin on breast density Comparison of metformin and placebo on breast mammography density in healthy women over 40 years 2020-11-24 anticipated 146 Complete https://irct.ir/trial/52499 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: The randomization process is performed by a simple random method with a random table of numbers, Blinding description: The random allocation list will be provided exclusively to the epidemiologist. To conceal the random allocation process,146 drugs envelopes with the same shape will be numbered with a 10-digit random code, which is the drug identification number. The code recognition key will be only available to the methodologist. All envelopes will be placed in a box in the order and on the basis of the random allocation list and will be available to the corresponding member. When the breast surgeon declares the patient's eligibility, the methodologist will provide the doctor with the envelope. The treatment plan will be selected based on the type of treatment mentioned in the envelope. In this study, the placebo is quite similar to the main drug (metformin).None of the patients should be aware of the type and treatment process they are seeking. Also, the person evaluating the outcomes is a third party who is unaware of the random allocation process and the type of treatment. The statistician who will analyze the data will be unaware of the type of intervention performed. 3 Breast density. Intervention 1: Intervention group: Consumption of 500 mg oral Metformin tablets twice a day for 6 months. Intervention 2: Control group: Consumption of oral placebo tablets (that are completely similar to the metformin tablets) twice a day for 6 months. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is It is not yet known if there will be a plan to make this available
public Sadaf Alipour
Arash Women 's Hospital, Rashid Ave, Resalat Highway, Tehranparse
Tehran Iran (Islamic Republic of) 1653915981 00982177888751 - 00982177883195 salipour@sina.tums.ac.ir Tehran University of Medical Sciences scientific D.r Sadaf Alipour
Arash Women 's Hospital, Rashid Blvd, Resalat Highway, Tehranparse
Tehran Iran (Islamic Republic of) 1653915981 +98 21777719922 salipour@Sina.tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Female gender Age over 40 years 40 years no limit Female Suspicion of malignancy Used of drugs that affect metabolic status, such as weight, glucose, and lipid-lowering agents During the study or three months before the study History of breast cancer Proven or suspected pregnancy and lactation during the intervention Other medical conditions, such as cardiovascular disease, epilepsy, renal or hepatic disorders Contraindications for metformin use (such as hypersensitivity to biguanides, acidemia, heart disease, alcohol consumption, gastroparesis, hepatic disease, hyperthyroidism or hypothyroidism, severe iron deficiency anemia, renal impairments) History of unwanted and intolerable side effects of metformin (such as abdominal pain, chest pain, chills, cholestasis, diarrhea, dizziness, increased liver enzymes, severe headache, hepatitis, hypoglycemia, megaloblastic anemia, myalgia, nausea, Palpitations, rash, rash, vomiting) Suffering from hormonal disorders and metabolic diseases such as hypo or hyperthyroidism, metabolic syndrome, diabetes, severe hyperlipidemia, galactorrhea Treatment - Drugs Placebo Intervention group: Consumption of 500 mg oral Metformin tablets twice a day for 6 months Control group: Consumption of oral placebo tablets (that are completely similar to the metformin tablets) twice a day for 6 months Breast density. Timepoint: At the beginning of the study (before the intervention) and six months after the intervention. Method of measurement: Mammography scan. Tehran University of Medical Sciences Approved 2020-11-11 Ethics Committee of Tehran University of Medical Sciences Qods St, Keshavarz Blvd Tehran Tehran Iran (Islamic Republic of)