Objectives: we evaluate the effect of metformin on thyroid nodules volume and size in the present study.
Design: Through a placebo-control double blind randomized clinical trial of phase 1, 240 euthyroid women from three endocrine clinics with benign thyroid nodules are selected and classified into four equal groups.
Setting and conduct: Thyroid nodule volume is detected by using ellipsoid formula (lengh×width×depth×π/6). Levothyroxine dose is adjusted based on serum TSH level, so that TSH is maintained between 0.5-2.5 mU/L and TSH is measured each month.
Participants: Euthyroid women with benign thyroid nodules between 0.5-3 cm and TSH between 0.5-2.5 mU/L.
Intervention: The first group take metformin 500 mg twice a day and the second group take levothyroxine 100 mcg once a day and the third group take a combination of metformin 500 mg twice a day and levothyroxine 100 mcg once a day for three months. The fourth group don,t take any drug during three months.
Main outcome measures: Primary outcome variables are the changes of thyroid nodules size. Secondary outcome variables are the changes of thyroid nodules numbers.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016022325895N3
Registration date:2016-12-04, 1395/09/14
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-12-04, 1395/09/14
Registrant information
Name
Afsaneh Talaei
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 3417 3612
Email address
talaei@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Arak University of Medical Sciences
Expected recruitment start date
2016-11-21, 1395/09/01
Expected recruitment end date
2017-03-21, 1396/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The evaluation of the effect of metformin on thyroid benign nodules
Public title
The effect of metformin on thyroid nodule
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Female sex, benign thyroid nodule with the size of 0.5-3 cm, euthyroid, negative TPO-Ab, TSH between 0.5-2.5 mU/L, lack of chronic disease, lack of drug usage
Exclusion criteria: Chronic usage of any kind of drugs more than three months, thyroid cystic nodules, malignant thyroid nodules
Age
From 20 years old to 70 years old
Gender
Female
Phase
1
Groups that have been masked
No information
Sample size
Target sample size:
240
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
random permuted blocks
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Arak University of Medical Sciences
Street address
Amiralmomenin Hospital, Baseej Square
City
Arak
Postal code
Approval date
2013-06-25, 1392/04/04
Ethics committee reference number
92-147-4
Health conditions studied
1
Description of health condition studied
Thyroid nodule
ICD-10 code
E04.1
ICD-10 code description
Nontoxic single thyroid nodule
Primary outcomes
1
Description
The changes of thyroid nodule size
Timepoint
The beginning of the study, after three months
Method of measurement
Ultrasonography
Secondary outcomes
1
Description
The changes of serum TSH level
Timepoint
The beginning of the study, the beginning of the second month, the beginning of the third month, the end of the third month
Method of measurement
Blood test
Intervention groups
1
Description
Intervention group 1: One tablet of metformin, 500 mg, oral, twice a day, produced by Iran Hormone co, for three months
Category
Treatment - Drugs
2
Description
Intervention group 2: One tablet of levothyroxine, 0.1 mg, oral, once a day, produced by Iran Hormone co, for three months
Category
Treatment - Drugs
3
Description
Intervention group 3: Combination of one tablet of metformin, 500 mg, oral, twice a day, produced by Iran Hormone co and one tablet of levothyroxine, 0.1 mg, oral, once a day, produced by Iran Hormone co, for three months
Category
Treatment - Drugs
4
Description
Control group: Without usage of any drugs for three months
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Amiralmomenin Hospital
Full name of responsible person
Afsaneh Talaei
Street address
Amiralmomenin Hospital, Baseej Square
City
Arak
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Arak University of Medical Sciences
Full name of responsible person
Mohammad Rafeie
Street address
Arak University of Medical Sciences, Baseej Square
City
Arak
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, Arak 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
Arak University of Medical Sciences
Full name of responsible person
Afsaneh Talaei
Position
Associate Professor of Endocrinology and Metabolism
Other areas of specialty/work
Street address
Amiralmomenin Hospital, Baseej Square
City
Arak
Postal code
3848176941
Phone
+98 86 3417 3612
Fax
Email
afsanehtalaeii@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Afsaneh Talaei
Position
Associate Professor of Endocrinology and Metabolism
Other areas of specialty/work
Street address
Amiralmomenin Hospital, Baseej Square
City
Arak
Postal code
3848176941
Phone
+98 86 3417 3612
Fax
Email
afsanehtalaeii@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Afsaneh Talaei
Position
Associate Professor of Endocrinology and Metabolism
Other areas of specialty/work
Street address
Amiralmomenin Hospital, Baseej Square
City
Arak
Postal code
3848176941
Phone
+98 86 3417 3612
Fax
Email
afsanehtalaeii@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)