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

April 18, 2011
April 25, 2011
April 2010
April 2011   (final data collection date for primary outcome measure)
TSH [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01341886 on ClinicalTrials.gov Archive Site
freeT3,freeT4 [ Time Frame: 3months ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Effect of Metformin on Decrement in Levothyroxin Dose Required for Thyroid Stimulating Hormone (TSH) Suppression in Patients With Differentiated Thyroid Cancer
Not Provided

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Malignant Neoplasm of Thyroid Stage I
  • Malignant Neoplasm of Thyroid Stage II
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.
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
51
April 2011
April 2011   (final data collection date for primary outcome measure)

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)
Both
up to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Iran, Islamic Republic of
 
NCT01341886
METTC
Yes
haleh rokni, endocrine research center
Mashhad University of Medical Sciences
Not Provided
Not Provided
Mashhad University of Medical Sciences
April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP