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CompletedNCT01341886Updated Apr 26, 2011

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

An interventional study of Metformin in Malignant Neoplasm of Thyroid Stage I and Malignant Neoplasm of Thyroid Stage II, sponsored by Mashhad University of Medical Sciences. Completed at 1 site in Iran, Islamic Republic of. Open to participants aged Up to 80 Years. Per ClinicalTrials.gov, last updated 2011-04-26.

Sponsored by Mashhad University of Medical Sciences · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
51
Allocation
Randomized
Ages
Up to 80 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Malignant Neoplasm of Thyroid Stage I
  • Malignant Neoplasm of Thyroid Stage II

Keywords

  • differentiated thyroid cancer
  • THS suppression
  • metformin
03

In context

Neoplasms

9,365 studies on the registry are indexed under Neoplasms; 2,486 are open to participants now.

This study's enrollment of 51 is close to the median of 50 across 7,250 interventional studies indexed under Neoplasms.

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Lead sponsor

Mashhad University of Medical Sciences is the lead sponsor of 90 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • cardiopulmonary failure
  • liver failure
  • renal failure
  • pregnancy
  • drugs (colestyramin, sucralfate, phenobarbital, phenytoin, carbamazepin, rifampin, amiodarone, chloroquin, androgens, sertraline, frusemide, heparin)
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
51 participants (actual)

Study arms

  • Active comparator
    metformin

    patients who receive metformin in addition to levothyroxine

    Drug: Metformin

  • Placebo comparator
    levothyroxine

    patients who receive only levothyroxine

    Drug: Metformin

Interventions

  • DrugMetformin

    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.

06

What researchers measure

Primary outcomes

  1. TSH

    Time frame: 3 months

Secondary outcomes

  1. freeT3,freeT4

    Time frame: 3months

07

Study locations

1 site
  • Mashad University of Medical Sciences
    Mashad, Khorasan Razavi, Iran, Islamic Republic of
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 26, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01341886
Lead sponsor
Mashhad University of Medical Sciences
First posted
Apr 26, 2011
Start date
Apr 2010
Primary completion
Apr 2011
Completion
Apr 2011
Last update
Apr 26, 2011

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2011. You cannot join it, but the record below documents what was studied.

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