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

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: April 2011

Interventions

  • 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.

Arms, Groups and Cohorts

  • Active Comparator: metformin
    • patients who receive metformin in addition to levothyroxine
  • Placebo Comparator: levothyroxine
    • patients who receive only levothyroxine

Clinical Trial Outcome Measures

Primary Measures

  • TSH
    • Time Frame: 3 months

Secondary Measures

  • freeT3,freeT4
    • Time Frame: 3months

Participating in This Clinical Trial

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 Eligibility: All

Minimum Age: N/A

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Mashhad University of Medical Sciences
  • Provider of Information About this Clinical Study
    • haleh rokni, endocrine research center

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