The aim of this clinical trial was evaluation of the effect of Metformin on reduction of Tirotropine level in patients with Subclinical hypothyroidism. Inclusion criteria included, do not use Thyrotropin-lowering drugs and Thyrotropin level between 5-10 miu/L. Exclusion criteria included lack of consent, renal insufficiency or GFR less than 50, Intolerance of oral Metformin and Pregnancy or post partum state. This study that performed on patients with Subclinical hypothyroidism. Sixty patients evaluated in two intervention and control groups. In intervention group, Tablet metformin 1 gr every 12 hours for 3 months and in the control group, Placebo will be prescribed. Thyroid function tests Will be measured before and after the study.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201304073565N8
Registration date:2015-07-05, 1394/04/14
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-07-05, 1394/04/14
Registrant information
Name
Akbar Aliasgarzadeh
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1335 7850
Email address
asgharzadeha@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Bone disease health center, Tabriz University of Medical Sciences
Expected recruitment start date
2015-05-22, 1394/03/01
Expected recruitment end date
2015-07-23, 1394/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effects of Metformin on thyroid function in patients with sub-clinical Hypothyroidism
Public title
Evaluation of the effect of Metformin on thyroid function
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Having metabolic syndrome criteria; Thyrotropin levels between 5 to 10 miu / L
Exclusion criteria: lack of consent; Renal insufficiency or GFR less than 50; Pregnancy
Age
From 18 years old to 65 years old
Gender
Both
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)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tabriz University of Medical Sciences
Street address
Tabriz University of Medical Sciences, Daneshgah Sq Tabriz Eastern Azarbyjan Iran, Islamic Republic Of
City
Tabriz
Postal code
Approval date
2015-01-10, 1393/10/20
Ethics committee reference number
93152
Health conditions studied
1
Description of health condition studied
Subclinical hypothyroidism
ICD-10 code
E02
ICD-10 code description
Subclinical iodine-deficiency hypothyroidism
Primary outcomes
1
Description
TSH Level
Timepoint
Before and 3 months after study
Method of measurement
Elisa method
2
Description
T4 Level
Timepoint
Before and 3 months after study
Method of measurement
Elisa method
Secondary outcomes
empty
Intervention groups
1
Description
In intervention group:
Tablet Metformin 1gr each 12 hours for 3 months
Category
Treatment - Drugs
2
Description
In control group:
Placebo each 12 hours for 3 months
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Endocrinology Clinic of Imam Reza Hospital
Full name of responsible person
Dr Zynolabedin Nurcheshmeh
Street address
Imam Reza medical research and training hospital, Daneshgah Ave, Tabriz
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Bone Research Center
Full name of responsible person
Dr. Amir Bahrami
Street address
Bone Research Center, Imam Reza medical research and training hospital, Daneshgah Ave, Tabriz
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bone Research Center
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
Tabriz University of Medical Sciences
Full name of responsible person
Dr Zynolabedin Nurcheshmeh
Position
Fellowship of Endocinologhy
Other areas of specialty/work
Street address
Bone Research Center, Imam Reza medical research and training hospital, Daneshgah Ave, Tabriz
City
Tabriz
Postal code
Phone
+98 41 3337 3966
Fax
Email
Nurcheshmehz@tbzmed.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
DR Nurcheshmeh
Position
Fellowship of Endocinologhy
Other areas of specialty/work
Street address
Imam Reza Hospital, Tabriz Department Of Internal Medicine Tabriz Eastern Azarbijan Iran, Islamic Republic Of
City
Tabriz
Postal code
Phone
+98 41 3337 3966
Fax
Email
Nurcheshmehz@tbzmed.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
DR Nurcheshmeh
Position
Fellowship of Endocinologhy
Other areas of specialty/work
Street address
Imam Reza Hospital, Tabriz Department Of Internal Medicine Tabriz Eastern Azarbijan Iran, Islamic Republic Of
City
Tabriz
Postal code
Phone
+98 41 3337 3966
Fax
Email
Nurcheshmehz@tbzmed.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)