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.
The aim of this Double Blind Randomized Controlled Trial, is to compare the effect of Bisphosphonate on blood glucose, sensitivity index and insulin premonition in Osteopenic menopause women in 2016-2017. The RCT will be carried out in the Endocrine and Metabolism Research Centre of Isfahan University of Medical Sciences and Hope Hospital Bone Densitometry Center (BMD). Among all patients who referred to Hope Hospital for bone densitometry, 60 eligible Osteopenic and prediabetes and menopause patients will be recruited and randomly allocated to intervention and control groups. The trial group will receive 70 mg Alendronate and control group placebo weekly for 3 months. The outcomes, blood Glucose, sensitivity index and insulin resistance will be measured at the baseline and at the end of follow up and compared between trial and control group.
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.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016101530309N1
Registration date:2016-12-31, 1395/10/11
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-12-31, 1395/10/11
Registrant information
Name
Maryam Karimifard
Name of organization / entity
Vice chancellor for research, Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3778 0358
Email address
m.karimifard@rums.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan Endocrine and Metabolism Research Center, Isfahan University of Medical Sciences
Expected recruitment start date
2016-03-20, 1395/01/01
Expected recruitment end date
2016-11-21, 1395/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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.
Public title
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.
Purpose
Prevention
Inclusion/Exclusion criteria
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.
Age
From 45 years old to 60 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee Isfahan University of Medical Sciences
Street address
No.4, Hezar jarib St, Isfahan
City
Isfahan
Postal code
8187698191
Approval date
2016-06-09, 1395/03/20
Ethics committee reference number
Ir.mui.rec.1395.3.292
Health conditions studied
1
Description of health condition studied
Prediabetes
ICD-10 code
R73, N95,
ICD-10 code description
Impaired glucose tolerance, Menopausal and other perimenopausal disorders, Postmenopausal osteoporosis
Primary outcomes
1
Description
25 OH D3
Timepoint
Before and three months after the study
Method of measurement
Blood test
2
Description
Plasma glucose, Insulin Sensitivity and Insulin Resistance, HbA1C
Timepoint
Before and three months after the study
Method of measurement
Blood test
3
Description
Lipid Profile TG - Total Cholostrol LDL-HDL
Timepoint
Before and three months after the study
Method of measurement
Blood test
Secondary outcomes
empty
Intervention groups
1
Description
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.
Category
Treatment - Drugs
2
Description
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.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Isfahan Endocrine and Metabolism Research Center, Isfahan University of Medical Sciences
Full name of responsible person
Dr.Kachuie
Street address
No.8, Khoram St, Jomhuri square, Isfahan
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Isfahan University of Medical Sciences
Full name of responsible person
Dr.Siavash
Street address
No.4, Hezar jarib St, Isfahan
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Isfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Isfahan Endocrine and Metabolism Research Center, Isfahan University of Medical Sciences
Full name of responsible person
Dr. Karimifard Maryam
Position
Assistant Professor of Endocrinology
Other areas of specialty/work
Street address
No.8, Khoram St, Jomhuri square, Isfahan
City
Isfahan
Postal code
Phone
+98 913 290 9538
Fax
Email
Karimifardmaryam6@GMAIL.COM
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan Endocrine and Metabolism Research Center, Isfahan University of Medical Sciences
Full name of responsible person
Dr.Ashraf Aminalroaya
Position
Professor
Other areas of specialty/work
Street address
No.8, Khoram St, Jomhuri square, Isfahan
City
Isfahan
Postal code
Phone
+98 3109131175398
Fax
Email
Ashraf.Aminorroaya42@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Isfahan Endocrine and Metabolism Research Center, Isfahan University of Medical Sciences
Full name of responsible person
Dr. karimifard Maryam
Position
Assistant Professor of Endocrinology
Other areas of specialty/work
Street address
No.8, Khoram St, Jomhuri square, Isfahan
City
Isfahan
Postal code
Phone
00
Fax
Email
M.KARIMIFARD@RUMS.AC.IR
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)