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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:
ClinicalTrials.gov Identifier:
NCT01341886
First Posted: April 26, 2011
Last Update Posted: April 26, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Mashhad University of Medical Sciences
  Purpose
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.

Condition Intervention
Malignant Neoplasm of Thyroid Stage I Malignant Neoplasm of Thyroid Stage II Drug: Metformin

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Mashhad University of Medical Sciences:

Primary Outcome Measures:
  • TSH [ Time Frame: 3 months ]

Secondary Outcome Measures:
  • freeT3,freeT4 [ Time Frame: 3months ]

Enrollment: 51
Study Start Date: April 2010
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: metformin
patients who receive metformin in addition to levothyroxine
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.
Placebo Comparator: levothyroxine
patients who receive only levothyroxine
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.

  Eligibility

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Ages Eligible for Study:   up to 80 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01341886


Locations
Iran, Islamic Republic of
Mashad University of Medical Sciences
Mashad, Khorasan Razavi, Iran, Islamic Republic of
Sponsors and Collaborators
Mashhad University of Medical Sciences
  More Information

Responsible Party: haleh rokni, endocrine research center
ClinicalTrials.gov Identifier: NCT01341886     History of Changes
Other Study ID Numbers: METTC
First Submitted: April 18, 2011
First Posted: April 26, 2011
Last Update Posted: April 26, 2011
Last Verified: April 2011

Keywords provided by Mashhad University of Medical Sciences:
differentiated thyroid cancer
THS suppression
metformin

Additional relevant MeSH terms:
Neoplasms
Thyroid Diseases
Thyroid Neoplasms
Endocrine System Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs