The people with pre-diabetes are insulin resistant. This situation can increased the risk of diabetes mellitus and cardiovascular diseases. On the other hand may affects thyroid function or its size and so may cause thyroid nodule. In the present study we are going to investigate the effects of metformin on the thyroid gland ( volume and function) in pre-diabetic patients. Our study is a double blind placebo- control clinical trial. The participants are selected from the first degree relatives of type-2 diabetes mellitus who are screened during a diabetes primary preventive program in Isfahan Endocrine and Metabolism Research Center. The patients target sample size will be 72 patients. The patients are randomly allocated to the 2 treatment groups. The first group will receive metformin and the second, placebo for 3 consequent months. After taking history and physical examination, blood sample will be taken and stored in -20 ˚C in Isfahan Endocrine and Metabolism Research Center lab until, laboratory assay will be done( CBC diff-Creatinin-AST-ALT-ALKP-T3-T4-TSH-T3RU-AntiThyroid Peroxidase Antibody- Anti Thyroglobulin Antibody –Triglyceride -Cholesterol -HDL Cholesterol -LDL Cholesterols- Insulin- HbA1C-FBS).
Thyroid ultrasound will be done before and 3 months after staring metformin or placebo. The patients will be seen every month and drug adherence was assessed by pill count. All the laboratory tests will be repeated after 3 months of receiving metformin or placebo. All patients with thyroid nodules >1 cm were offered to undergo fine needle aspiration biopsy (FNAB).
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013121215765N1
Registration date:2014-05-29, 1393/03/08
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-05-29, 1393/03/08
Registrant information
Name
Mozhgan Karimifar
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1441 4680
Email address
mozh.karimifar@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan Endocrine and Metabolism Research Center, Raha Pharmaceutical Company
Expected recruitment start date
2013-04-01, 1392/01/12
Expected recruitment end date
2014-03-16, 1392/12/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Metformin and placebo effects on TSH and thyroid volume in patients with pre-diabetes
Public title
Metformin and placebo effects on TSH and thyroid volume in patients with pre-diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria :patients with pre-diabetes [Impaired fasting plasma glucose (100 to 125 mg/dl) or impaired glucose tolerance (IGT) (2-h PG OGTT values of 140–199 mg/dL and having 18 to 65 years old] were initially included.
Exclusion criteria:
Those patients with thyroid malignancy or any other malignancy; previous-thyroxin suppression therapy at any time; obesity due to endocrine disease; Pregnancy and lactation; renal failure or liver failure; neurological or psychological disorders (depression, epilepsy, schizophrenia); heart failure; hypothyroidism or hyperthyroidism; smoking and finally iodinated contrast material exposure in the previous 6 months ago all were excluded from the study.
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:
76
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
Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, Hezar Jarib Avenu,Isfahan, Iran
City
Isfahan
Postal code
Approval date
2013-08-20, 1392/05/29
Ethics committee reference number
392299
Health conditions studied
1
Description of health condition studied
Thyroid gland
ICD-10 code
E00-E07,E0
ICD-10 code description
Disorders of thyroid gland
2
Description of health condition studied
Prediabetes
ICD-10 code
R73.0
ICD-10 code description
Impaired glucose tolerance
Primary outcomes
1
Description
Thyroid Stimulating Hormone
Timepoint
Baseline and 3 months later
Method of measurement
TSH : were performed using immunoassay system by an automated analyzer Siemens 2010 (ADVIA Centaur CP Immunoassay System).
2
Description
Thyroid volume
Timepoint
Before and after 3 months treatment
Method of measurement
Thyroid ultrasonography was performed by single physician, who was unaware of the patients’ any clinical conditions, using a 7 - 9 MHz linear probe ( Logiq 500 Pro, GE Medical Systems, WI, USA).
Secondary outcomes
1
Description
Thyroid Nodule
Timepoint
Baseline and 3 months later
Method of measurement
Thyroid ultrasound by logic 500 general electric probe 7-9
2
Description
IR=Homeostasis Model Assessment Of Insulin Resistance
One group will receive placebo with a sercret code.
(Subjects were instructed to take 1 tablet 500 mg placebo daily. But in the 1st week, subjects were instructed to take 2 tablet 500 mg daily, if subjects tolerated the dose-escalation protocol without significant side effects, the daily dose was increased to 1500 mg daily).
Category
Placebo
2
Description
The other group will receive metformin with a secret code. (Subjects were instructed to take 1 tablet 500 mg Metformin daily. But in the 1st week, subjects were instructed to take 2 tablet 500 mg daily, if subjects tolerated the dose-escalation protocol without significant side effects, the daily dose was increased to 1500 mg daily).
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Endocrine and Metabolism Research Center, Isfahan University of Medical Sciences
Full name of responsible person
Mozhgan Karimifr,Internist,Fellowship of Endocrinology and metabolism
Street address
Isfahan Endocrine and Metabolism Research Center, Khorram avenue, Isfahan, Iran
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Isfahan Endocrine and Metabolism Research Center
Full name of responsible person
Ashraf Aminorroaya MD-Professor of Internal Medicine and Endocrinology-Head of Endocrinology Departm
Street address
Isfahan Endocrine and Metabolism Research Center, Khorram Street ,Isfahan,Iran
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Isfahan Endocrine and Metabolism Research Center
Proportion provided by this source
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
2
Sponsor
Name of organization / entity
Raha Pharmaceutical Company
Full name of responsible person
Mohammadali Mansouri Tehrani - Director of sales and marketing of Raha pharmaceutical company
Street address
Unit 11, Shahrak Sanaty Soffe , kilometer Seven , Shiraz road.
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Raha Pharmaceutical Company
Proportion provided by this source
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
Full name of responsible person
Mozhgan karimifar
Position
Fellowship of endocrinology
Other areas of specialty/work
Street address
Isfahan Endocrine and Metabolism Research Center, Khorram Street ,Isfahan,Iran
City
Isfahan
Postal code
Phone
+98 31 1335 9933
Fax
Email
mozh.karimifar@med.mui.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan Endocrine and Metabolism Research Center
Full name of responsible person
Ashraf Aminorroaya
Position
Professor of Internal Medicine and Endocrinology
Other areas of specialty/work
Street address
Isfahan Endocrine and Metabolism Research Center, Khorram Street ,Isfahan,Iran
City
Isfahan
Postal code
Phone
+98 31 1335 9933
Fax
Email
Ashraf.aminorroaya42@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Mozhgan karimifar
Position
Fellowship of endocrinology
Other areas of specialty/work
Street address
Alzahra hospital, Soffe avenue, Isfahan,Iran
City
Isfahan
Postal code
Phone
+98 31 1624 9031
Fax
Email
mozh.karimifar@med.mui.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)