Text Size

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
  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: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • TSH [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • freeT3,freeT4 [ Time Frame: 3months ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   up to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: haleh rokni, endocrine research center
ClinicalTrials.gov Identifier: NCT01341886     History of Changes
Other Study ID Numbers: METTC
Study First Received: April 18, 2011
Last Updated: April 25, 2011
Health Authority: Iran: Ethics Committee

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

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

ClinicalTrials.gov processed this record on May 16, 2013