1)objectives: evaluation of metformin effect on progression of autosomal dominant polycystic kidney disease. 2)Design: double blind randomized placebo controlled trial. 3)Setting and conduct: measurement of kidneys volume with MRI in 30 patients with autosomal dominant polycystic kidney disease in Firoozgar hospital, then prescription of drug or placebo for 6 months after random allocation to two groups, then measurement of kidneys volume again. 4)Participants: patients with diagnosis of autosomal dominant polycystic kidney disease. major eligibility criteria: age between 18-60 years old; glomerular filtration rate >=60cc/min. exclusion criteria: history of diabetes mellitus; history of congestive heart failure; history of liver failure. 5)Interventions: metformin or placebo. 6)main outcome measures: kidneys volume
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012102111194N1
Registration date:2013-02-13, 1391/11/25
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-02-13, 1391/11/25
Registrant information
Name
Foroogh Sabzghabaei
Name of organization / entity
Tehran University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 21 8214 1600
Email address
f-sabzghabaei@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research,Tehran University of Medical Science
Expected recruitment start date
2013-02-01, 1391/11/13
Expected recruitment end date
2014-02-01, 1392/11/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of metformin effect on progression of autosomal dominant polycystic kidney disease; a clinical trial
Public title
Evaluation of metformin effect on progression of autosomal dominant polycystic kidney disease; a clinical trial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion: Known case of Autosomal dominant polycystic kidney disease (by sonography); age between 18-60 years old; GFR>=60 cc/min.
Exclusion: history of diabetes mellitus; history of heart failure; history of liver failure
Age
From 18 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
1
Registry name
no
Secondary trial Id
no
Registration date
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic committee of Tehran University of Medical Science
Street address
Ghods st., Keshavarz Blvd.
City
Tehran
Postal code
Approval date
2012-12-26, 1391/10/06
Ethics committee reference number
17059
Health conditions studied
1
Description of health condition studied
Autosomal Dominant Polycystic Kidney Disease
ICD-10 code
Q61.2
ICD-10 code description
Polycystic kidney, adult type
Primary outcomes
1
Description
kidneys volume
Timepoint
6 months
Method of measurement
Magnetic Resonance Imaging
Secondary outcomes
empty
Intervention groups
1
Description
Tablet Metformin 500 mg three times a day
Category
Treatment - Drugs
2
Description
Tablet placebo one tab three times a day
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Firoozgar Hospital
Full name of responsible person
Dr. Foroogh Sabzghabaei
Street address
Behafarin St., Karimkhan Zand Ave., Valiasr Sq.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor for research,Tehran University of Medical Science
Full name of responsible person
Akbar Fotuhi M.D.
Street address
Ghods st., Keshavarz Blvd.
City
Tehran
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,Tehran University of Medical Science
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
Tehran University of Medical Science
Full name of responsible person
Dr. Foroogh Sabzghabaei
Position
Nephrologist/ assistant professor
Other areas of specialty/work
Street address
Behafarin St., Karimkhan Zand Ave., Valiasr Sq.
City
Tehran
Postal code
Phone
+98 21 8214 1600
Fax
+98 21 8214 1321
Email
f-sabzghabaei@tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Science
Full name of responsible person
Dr. Foroogh Sabzghabaei
Position
nephrologist/ assistant professor
Other areas of specialty/work
Street address
Behafarin St., Karimkhan Zand Ave., Valiasr Sq.
City
Tehran
Postal code
Phone
+98 21 8214 1600
Fax
+98 82141321
Email
f-sabzghabaei@tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Science
Full name of responsible person
Dr Foroogh Sabzghabaei
Position
Nephrologist/ assistant professor
Other areas of specialty/work
Street address
Behafarin St., "Karimkhan zand" Ave., Valiasr Sq.
City
Tehran
Postal code
Phone
+98 82141600
Fax
Email
f-sabzghabaei@tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)