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IRCT2016101530309N1 IRCT 2016-12-31 Vice chancellor for research, Isfahan University of Medical Sciences Comparison of the effect of Bisphosphonate on the prevention of type 2 diabetes among Osteopenic menopause prediabetes women and Referred to Isfahan Endocrine and Metabolism Research Center. Comparison of the effect of Bisphosphonate on the prevention of type 2 diabetes among Osteopenic menopause prediabetes women and Referred to Isfahan Endocrine and Metabolism Research Center. 2016-03-20 anticipated 60 Complete https://irct.ir/trial/24126 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention. 2-3 Prediabetes. Intervention 1: Randomisation and blinding: Patients who are screened, signed the consent form, and fulfilled inclusion criteria and meet no exclusion criteria will be randomised using a sealed envelope to either 70 mg Alendronate (trial group) or placebo (control group). The randomisation and preparation of sealed envelopes are performed by an independent party at the Hope Hospital. Randomisation will be performed using a computerised random number generator. The research team is blinded to block size. Measurements of, blood Glucose, sensitivity index and insulin resistance will be performed by a member of the research team who is blinded to the treatment allocation at the baseline and at the end of follow up. Control group: Thirty patients whom allocated to placebo group, will be treated as trial group. They will receive placebo tablet exactly the same size and colour of Alendronate tablet without substance with therapeutic effect. Control group patients will also be asked to take one tablet once a week for 12 weeks in the morning while fasting with one glass of water and no lying down, at least, an hour after taking the tablet. They will receive information on all potential side effects and how to cope with if any side effect happened. Intervention 2: Randomisation and blinding: Patients who are screened, signed the consent form, and fulfilled inclusion criteria and meet no exclusion criteria will be randomised using a sealed envelope to either 70 mg Alendronate (trial group) or placebo (control group). The randomisation and preparation of sealed envelopes are performed by an independent party at the Hope Hospital. Randomisation will be performed using a computerised random number generator. The research team is blinded to block size. Measurements of, blood Glucose, sensitivity index and insulin resistance will be performed by a member of the research team who is blinded to the treatment allocation at the baseline and at the end of follow up. Trial group: Both trial and control group will be asked to take one Alendronate tablets is a bisphosphonate drug, it is chemically related to inorganic pyrophosphate, the endogenous regulator of bone turnover, once a week for 12 weeks in the morning while fasting with one glass of water and no lying down, at least, an hour after taking the tablet. All patients will be given information on all potential side effects and how to cope with if any side effect happened.
public Dr. Karimifard Maryam
No.8, Khoram St, Jomhuri square, Isfahan
Isfahan Iran (Islamic Republic of) +98 913 290 9538 Karimifardmaryam6@GMAIL.COM Isfahan Endocrine and Metabolism Research Center, Isfahan University of Medical Sciences scientific Dr.Ashraf Aminalroaya
No.8, Khoram St, Jomhuri square, Isfahan
Isfahan Iran (Islamic Republic of) +98 3109131175398 Ashraf.Aminorroaya42@gmail.com Isfahan Endocrine and Metabolism Research Center, Isfahan University of Medical Sciences Iran (Islamic Republic of) Inclusion and exclusion criteria Inclusion criteria Prediabetes and menopause female patients who are resistant to insulin at age between 45 to 60 will be included if fulfilling the following two criteria: Osteopenia based on bone density measured by DAX machine Hologic 2008 model; Written consent by the patient to participate in the study obtained at the baseline Exclusion criteria Patients fulfilling any of the following criteria will be excluded from the study; Failure to use vitamin of OTC or trace element; Patients who do not like to continue with the study for any reason; Patients who take drugs that affect metabolism of glucose; The Osteoporotic patient; Patients with kidney failure problem. 45 years 60 years Female R73, N95, Impaired glucose tolerance, Menopausal and other perimenopausal disorders, Postmenopausal osteoporosis Treatment - Drugs Treatment - Drugs Randomisation and blinding: Patients who are screened, signed the consent form, and fulfilled inclusion criteria and meet no exclusion criteria will be randomised using a sealed envelope to either 70 mg Alendronate (trial group) or placebo (control group). The randomisation and preparation of sealed envelopes are performed by an independent party at the Hope Hospital. Randomisation will be performed using a computerised random number generator. The research team is blinded to block size. Measurements of, blood Glucose, sensitivity index and insulin resistance will be performed by a member of the research team who is blinded to the treatment allocation at the baseline and at the end of follow up. Control group: Thirty patients whom allocated to placebo group, will be treated as trial group. They will receive placebo tablet exactly the same size and colour of Alendronate tablet without substance with therapeutic effect. Control group patients will also be asked to take one tablet once a week for 12 weeks in the morning while fasting with one glass of water and no lying down, at least, an hour after taking the tablet. They will receive information on all potential side effects and how to cope with if any side effect happened. Randomisation and blinding: Patients who are screened, signed the consent form, and fulfilled inclusion criteria and meet no exclusion criteria will be randomised using a sealed envelope to either 70 mg Alendronate (trial group) or placebo (control group). The randomisation and preparation of sealed envelopes are performed by an independent party at the Hope Hospital. Randomisation will be performed using a computerised random number generator. The research team is blinded to block size. Measurements of, blood Glucose, sensitivity index and insulin resistance will be performed by a member of the research team who is blinded to the treatment allocation at the baseline and at the end of follow up. Trial group: Both trial and control group will be asked to take one Alendronate tablets is a bisphosphonate drug, it is chemically related to inorganic pyrophosphate, the endogenous regulator of bone turnover, once a week for 12 weeks in the morning while fasting with one glass of water and no lying down, at least, an hour after taking the tablet. All patients will be given information on all potential side effects and how to cope with if any side effect happened. 25 OH D3. Timepoint: Before and three months after the study. Method of measurement: Blood test. Plasma glucose, Insulin Sensitivity and Insulin Resistance, HbA1C. Timepoint: Before and three months after the study. Method of measurement: Blood test. Lipid Profile TG - Total Cholostrol LDL-HDL. Timepoint: Before and three months after the study. Method of measurement: Blood test. Vice chancellor for research, Isfahan University of Medical Sciences Approved 2016-06-09 Ethics Committee Isfahan University of Medical Sciences No.4, Hezar jarib St, Isfahan Isfahan Iran (Islamic Republic of)