The objective of this study is to investigate 50 post-menopausal women with Type 2 diabetes and albuminuria (Albumin/Creatinine Ratio [ACR] ≥ 30 µg/mg) will be included in a 4-month, double-blind, placebo-controlled trial to receive either 60 mg raloxifene per day or placebo. Body mass index (BMI), blood pressure (BP), fasting blood glucose (FBS), HbA1C, lipid profiles, serum creatinine concentration (Cr), and random urine for ACR, will be measured for all the participants at the baseline and the end of the study.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138904151179N4
Registration date:2011-03-20, 1389/12/29
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-03-20, 1389/12/29
Registrant information
Name
Faranak Sharifi
Name of organization / entity
Zanjan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 24 1727 0815
Email address
zmdrc@zums.ac.ir
Recruitment status
Recruitment complete
Funding source
Metabolic Diseases Research Center, Zanjan University of Medical Sciences
Expected recruitment start date
2009-09-23, 1388/07/01
Expected recruitment end date
2010-09-23, 1389/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of raloxifen in post menopausal women with diabetic nephropathy
Public title
Effect of raloxifen on kidney function in post menopausal women with diabetic nephropathy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria : confirmed menopause (last period of the patient over the past year and FSH levels is more than 25mu/L, Age less than 70 years, confirmed albuminuria due to DM (ACR> 30mg/gr)
Exclusion criteria: History of Treatment with estrogen or SERM in the past six months, a personal history of breast or Genicologic cancer, History of thrombotic disorders, GFR less than 30 mL/min, hypertriglyceridemia over than 400 mg/dl, Active liver disease, intolerance to raloxifene or other Allergic reactions
Age
From 45 years old to 70 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
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
Zanjan University of Medical Sciences Ethical Committee
Street address
Azadi Boulevard
City
Zanjan
Postal code
4515613191
Approval date
2009-10-18, 1388/07/26
Ethics committee reference number
4526/3-3/19
Health conditions studied
1
Description of health condition studied
Diabetic Nephropathy
ICD-10 code
E10, E11,
ICD-10 code description
Primary outcomes
1
Description
Albuminuryia
Timepoint
at the begining of the study and 4month after intervention
Method of measurement
Nephelometry
Secondary outcomes
1
Description
lipid profile(TG, Cholesterol, HDL-C)
Timepoint
at the begining of the study and 4month after intervention
Method of measurement
Enzymatic methods
2
Description
Blood pressure
Timepoint
at the begining of the study and 2&4 month after intervention
Method of measurement
standard methods checking for BP
3
Description
HbA1c
Timepoint
at the beginning of the study and 4 months after intervention
Method of measurement
lone exchange
Intervention groups
1
Description
placebo for 4 months
Category
Placebo
2
Description
Raloxifen tablets 60mg/daily for 4 months
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Endocrine Clinic of Zanjan, Vali -e-Asr Hospital
Full name of responsible person
Dr.Faranak Sharifi
Street address
Vali-e-Asr Hospital, Zanjan , Iran
City
Zanjan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zanjan Metabolic Diseases Research Center, Zanjan University of Medical Sciences
Full name of responsible person
Dr.Alireza Biglari
Street address
Azadi Boulevard
City
Zanjan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zanjan Metabolic Diseases Research Center, Zanjan 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
Zanjan Metabolic Diseases Research Center
Full name of responsible person
Dr. Faranak Sharifi
Position
Associate professor
Other areas of specialty/work
Street address
Vali-e-Asr Hospital , Zanjan Metabolic Diseases Research Center
City
Zanjan
Postal code
45157-77978
Phone
+98 24 1727 0814
Fax
+98 24 1727 0815
Email
faranaksharifi@hotmail.com zmdrc@zums.ac.ir
Web page address
www.zums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zanjan Metabolic diseases Research Center
Full name of responsible person
Dr.Faranak Sharifi
Position
Associate professor
Other areas of specialty/work
Street address
Zanjan Metabolic diseases Research Center, Vali-e-Asr Hospital