Effect of Metformin on Decrement in Levothyroxin Dose Required for Thyroid Stimulating Hormone (TSH) Suppression in Patients With Differentiated Thyroid Cancer

This study has been completed.

Sponsor:

Information provided by:

Mashhad University of Medical Sciences

ClinicalTrials.gov Identifier:

NCT01341886

First received: April 18, 2011

Last updated: April 25, 2011

Last verified: April 2011

History of Changes

Tracking Information
First Received Date ^ICMJE	April 18, 2011
Last Updated Date	April 25, 2011
Start Date ^ICMJE	April 2010
Primary Completion Date	April 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: April 25, 2011)	TSH [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01341886 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: April 25, 2011)	freeT3,freeT4 [ Time Frame: 3months ] [ Designated as safety issue: Yes ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Effect of Metformin on Decrement in Levothyroxin Dose Required for Thyroid Stimulating Hormone (TSH) Suppression in Patients With Differentiated Thyroid Cancer
Official Title ^ICMJE	Not Provided
Brief Summary	Differentiated thyroid cancer is the most common neoplasm of endocrine system. After surgery and radioiodine treatment, thyroid stimulating hormone (TSH) suppression is the main goal which is achieved with levothyroxine treatment. Levothyroxine causes increased thyroid hormones which can have negative impact on bone and cardiovascular system. Anecdotal reports have shown that metformin can induce TSH suppression without change in T3 and T4 concentration. The purpose of this study was to prescribe metformin as additional drug to levothyroxin in order to decrease levothyroxine dosage.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Malignant Neoplasm of Thyroid Stage I Malignant Neoplasm of Thyroid Stage II
Intervention ^ICMJE	Drug: Metformin in case group metformin is added to levothyroxine and levothyroxine is decreased by 30% .in control group levothyroxine is reduced by 30% and no metformin is added to the regimen.
Study Arm (s)	Active Comparator: metformin patients who receive metformin in addition to levothyroxine Intervention: Drug: Metformin Placebo Comparator: levothyroxine patients who receive only levothyroxine Intervention: Drug: Metformin
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	51
Completion Date	April 2011
Primary Completion Date	April 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: papillary or follicular thyroid cancer stage 1 or 2 according to TNM system version 6 surgery and radioiodine treatment levothyroxine suppression treatment Exclusion Criteria: cardiopulmonary failure liver failure renal failure pregnancy drugs (colestyramin, sucralfate, phenobarbital, phenytoin, carbamazepin, rifampin, amiodarone, chloroquin, androgens, sertraline, frusemide, heparin)
Gender	Both
Ages	up to 80 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Iran, Islamic Republic of

Administrative Information
NCT Number ^ICMJE	NCT01341886
Other Study ID Numbers ^ICMJE	METTC
Has Data Monitoring Committee	Yes
Responsible Party	haleh rokni, endocrine research center
Study Sponsor ^ICMJE	Mashhad University of Medical Sciences
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Mashhad University of Medical Sciences
Verification Date	April 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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